Clinical Trial Ongoing Third Party Oversight Document

2020 ◽  
Author(s):  
Keyword(s):  
Clinical Trial ◽  
Third Party

Evaluating the Financial Impact of Clinical Trials in Oncology: Results From a Pilot Study From the Association of American Cancer Institutes/Northwestern University Clinical Trials Costs and Charges Project

2000 ◽  
Vol 18 (15) ◽  
pp. 2805-2810 ◽  
Author(s):  
Charles L. Bennett ◽  
Tammy J. Stinson ◽  
Victor Vogel ◽  
Lyn Robertson ◽  
Donald Leedy ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Pilot Study ◽  
Medical Care ◽  
Phase Ii ◽  
Third Party ◽  
Disease Stage ◽  
Cancer Center ◽  
Policy Debate ◽  
Economic Analyses

PURPOSE: Medical care for clinical trials is often not reimbursed by insurers, primarily because of concern that medical care as part of clinical trials is expensive and not part of standard medical practice. In June 2000, President Clinton ordered Medicare to reimburse for medical care expenses incurred as part of cancer clinical trials, although many private insurers are concerned about the expense of this effort. To inform this policy debate, the costs and charges of care for patients on clinical trials are being evaluated. In this Association of American Cancer Institutes (AACI) Clinical Trials Costs and Charges pilot study, we describe the results and operational considerations of one of the first completed multisite economic analyses of clinical trials. METHODS: Our pilot effort included assessment of total direct medical charges for 6 months of care for 35 case patients who received care on phase II clinical trials and for 35 matched controls (based on age, sex, disease, stage, and treatment period) at five AACI member cancer centers. Charge data were obtained for hospital and ancillary services from automated claims files at individual study institutions. The analyses were based on the perspective of a third-party payer. RESULTS: The mean age of the phase II clinical trial patients was 58.3 years versus 57.3 years for control patients. The study population included persons with cancer of the breast (n = 24), lung (n = 18), colon (n = 16), prostate (n = 4), and lymphoma (n = 8). The ratio of male-to-female patients was 3:4, with greater than 75% of patients having stage III to IV disease. Total mean charges for treatment from the time of study enrollment through 6 months were similar: $57,542 for clinical trial patients and $63,721 for control patients (1998 US$; P = .4) CONCLUSION: Multisite economic analyses of oncology clinical trials are in progress. Strategies that are not likely to overburden data managers and clinicians are possible to devise. However, these studies require careful planning and coordination among cancer center directors, finance department personnel, economists, and health services researchers.

scholarly journals Continued Access to Investigational Medicinal Products for Clinical Trial Participants—An Industry Approach

2018 ◽  
Vol 28 (1) ◽  
pp. 124-133 ◽  
Author(s):  
ARIELLA KELMAN ◽  
ANNA KANG ◽  
BRIAN CRAWFORD
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Pharmaceutical Research ◽  
Development Program ◽  
Well Being ◽  
Third Party ◽  
Clinical Development Program ◽  
Clinical Trial Evidence ◽  
Access To Medical Care ◽  
Trial Participants

Abstract:In the conduct of clinical trials for pharmaceutical research, access to investigational medicines following clinical trials is often necessary for the continued health and well-being of the trial participants; it is an ethical obligation under some circumstances, as outlined in the Declaration of Helsinki 2013 Article 34. This obligation becomes particularly important in lower-income countries, where access to medical care may be limited. Although there is agreement among global research and bioethics communities that continued access should be provided with prospectively defined parameters and procedures, the process is complex, as many responsible parties and complicated logistics are involved. Roche Pharmaceuticals developed and publicly posted the company’s policy regarding continued access to investigational medicines in 2013. This article provides insights on the policy, including the parameters that determine when continued access is and is not considered to be appropriate, along with an example from an active clinical development program. It also describes how multiple stakeholders, including those in academia, industry, government, and patient advocacy, have worked together to assess approaches to continued access. Continued access plans should be transparent and agreed to by research participants, investigators, and governments prior to the study and reassessed based on clinical trial evidence of safety and efficacy and availability of adequate treatments, along with relevant international laws and customs. Conducting responsible continued access programs requires close partnerships with investigators, health authorities, and third-party research partners.

Blockchain in Clinical Trials

2021 ◽  
pp. 278-292
Author(s):  
Shaveta Malik ◽  
Archana Mire ◽  
Amit Kumar Tyagi ◽  
Arathi Boyanapalli
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Data Sharing ◽  
Study Protocol ◽  
Data Security ◽  
Personal Data ◽  
Third Party ◽  
Report Generation ◽  
Blockchain Technology

Clinical research comprises participation from patients. Often there are concerns of enrolment from patients. Hence, it has to face various challenges related to personal data, such as data sharing, privacy and reproducibility, etc. Patients and researchers need to track a set plan called study protocol. This protocol spans through various stages such as registration, collection and analysis of data, report generation, and finally, results in publication of findings. The Blockchain technology has emerged as one of the possible solutions to these challenges. It has a potential to address all the problem associated with clinical research. It provides the comfort for building transparent, secure services relying on trusted third party. This technology enables one to share the control of the data, security, and the parameters with a single patient or a group of patients or any other stakeholders of clinical trial. This chapter addresses the use of blockchain in execution of secure and trusted clinical trials.

scholarly journals A randomized clinical trial of nasogastric tube insertion in intubated patient: comparison between finger method and reverse Sellick maneuver

2019 ◽  
Vol 28 (4) ◽  
pp. 311-5
Author(s):  
Rahendra ◽  
Aida Rosita Tantri ◽  
Liliana Mangkuwerdojo
Keyword(s):  
Clinical Trial ◽  
Success Rate ◽  
Randomized Clinical Trial ◽  
Nasogastric Tube ◽  
Complication Rate ◽  
Third Party ◽  
Chi Square ◽  
Group 13 ◽  
Blood Spots ◽  
Chi Square Test

BACKGROUND Finger method is a new simple technique of nasogastric tube (NGT) insertion for intubated patients which only requires the practitioner’s own fingers. This study was aimed to compare the feasibility of finger method and the standard reverse Sellick maneuver in NGT insertion for intubated patients. METHODS This was a single-blinded, randomized clinical trial that included 210 patients aged 18–65 years old who were intubated under general anesthesia and needed NGT insertion. Initially, subjects were randomly allocated by the third party into two groups: subjects who had NGT insertion with finger method and those with reverse Sellick maneuver. Success rate of NGT insertion at the first attempt, duration of the procedure, and complication rate of blood spots were all recorded. Chi-square test and Mann–Whitney analysis were used to analyze the data. RESULTS Success rate of NGT insertion at the first attempt in finger method group was higher in comparison with reverse Sellick maneuver group (81.6% versus 60%, respectively, p = 0.002). Likewise, the median of NGT insertion duration was longer in finger group compared to reverse Sellick maneuver group (13 sec versus 12 sec, respectively, p < 0.001) but it was not clinically significant. Moreover, the complication rate of blood spots found during the procedure was lower in subjects with finger method than with reverse Sellick maneuver (10.7% versus 28%, respectively, p = 0.003). CONCLUSIONS Using finger method was more feasible than reverse Sellick maneuvers in NGT insertion.

A “Talent Agency” refers children for research: A case study

2021 ◽  
pp. 147775092110366
Author(s):  
David C Schwebel ◽  
Anna Johnston ◽  
Leslie A McClure
Keyword(s):  
Clinical Trial ◽  
Research Participation ◽  
Third Party ◽  
Ethical Standards ◽  
Undue Influence ◽  
Ethical Violations ◽  
Institutional Review ◽  
Study Results ◽  
Rate Of Learning

Objective Ethical standards state research participation must be voluntary and free of coercion and undue influence, but what if a third party appears to engage in research-relevant coercion, without the researchers’ knowledge? This case study describes this type of situation and its resolution. Methods We are engaged in a randomized clinical trial evaluating pedestrian safety with 7- and 8- years old. Depending on children's rate of learning, families receive up to $1275 for their time. We recently learned a third-party “talent agency,” a firm placing children in modeling and acting jobs, was referring families to our research with the expectation that families would share 20% of study reimbursements. Results We sensed clear impropriety, but identified no ethical violations on our part as researchers. Once paid a study reimbursement, participants can spend funds how they wish. We were concerned, however, that the third-party was exploitatively coercing families to participate. Conclusions We pursued four avenues to resolve the issue. First, we documented the situation to our university Institutional Review Board. Second, we contacted the talent agency and requested they stop referring families to our research. They agreed. Third, we retained children engaged in our study who were referred from the talent agency; removing them partway through the clinical trial could impact study results. In doing so, we explained that we were unaware of the talent agency referral and that they were not obligated by us to offer a portion of the study reimbursement to the talent agency. Last, we asked newly enrolled families about their referral source.

A phase I clinical trial testing the safety of IL-21-expanded, off-the-shelf, natural killer cells for relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. TPS7562-TPS7562
Author(s):  
Sumithira Vasu ◽  
Nidhi Sharma ◽  
Lynn Odonnell ◽  
Kevin Bosse ◽  
Dean Anthony Lee
Keyword(s):  
Clinical Trial ◽  
Acute Myeloid Leukemia ◽  
Myelodysplastic Syndrome ◽  
Phase I ◽  
Nk Cells ◽  
Natural Killer ◽  
Myeloid Leukemia ◽  
Nk Cell ◽  
Third Party ◽  
Acute Myeloid

TPS7562 Background: Allogeneic transplantation (Allo-HCT) demonstrates the enduring and potent role of the immune system in the control and eradication of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). However, patients with relapsed, refractory (R/R) disease or comorbidities are not eligible for Allo-HCT. We sought to develop an allogeneic Natural killer (NK) cell-based immunotherapy approach to induce remission for these patients. The efficacy of haploidentical NK cells expanded ex vivo using a K562 feeder-cell line transfected with IL-21 and 41BBL has been established in R/R AML patients. However, haploidentical donor-derived NK cell manufacturing exceeds three weeks with the possibility of fulminant malignancy rendering patients ineligible for cellular therapy. To address this limitation we established a third-party NK cell bank derived from KIR and HLA-mismatched ‘ideal’ donors that allows scalable, affordable mass-production of large numbers of NK cells suitable for banking and immediate ‘off-the-shelf’ (OTS) administration to a broad population of recipients. Methods: This phase I study follows a 3+3 design to investigate the safety of mIL-21-expanded, third-party, OTS NK cells for treatment of R/R AML and MDS patients. Patients aged ≥18 or ≤80 years are enrolled into two cohorts: those <60 years and able to tolerate intensive chemo will receive Fludarabine 30mg/m2/day (days -6 to -2) and Cytarabine 2g/m2/day (days -6 to -2). Patients >60 years or <60 years and unable/unwilling to tolerate intensive chemo will receive Fludarabine 30mg/m2/day (days -5 to -2) and Decitabine 20mg/m2/day (days -6 to -2). All patients subsequently receive a total of 6 infusions of NK cells administered thrice weekly for two weeks (between days 0-21) and will be followed up to day 56 from first NK cell infusion. Three NK cell dose-levels: 1x107, 3x107 and 1x108 cells/kg/dose will be explored to determine maximum tolerated dose (MTD). 3-18 patients/cohort/dose may be enrolled for MTD determination plus an additional 10 patients/dose in an expansion phase (maximum 28/cohort = 56 total subjects). Primary objective is to determine safety and feasibility of NK cell infusions. Secondary objectives will explore rates of remission PFS, overall survival and measurable residual disease negativity, cell counts, infectious complications, and patients proceeding to transplant. Enrollment in dose level 1 has started. Clinical trial information: NCT04220684 .

Single-centre study on the use of virtual reality in the reduction of pain after the administration of vaccines in children aged 3 to 6 years in primary care centres in Central Catalonia: randomized clinical trial (Preprint)

2021 ◽  
Author(s):  
Mercedes de la Cruz Herrera ◽  
Aïna Fuster Casanovas ◽  
Queralt Miró Catalina ◽  
Mireia Cigarrán Mensa ◽  
Pablo Alcántara Pinillos ◽  
...  
Keyword(s):  
Primary Care ◽  
Clinical Trial ◽  
Virtual Reality ◽  
Intervention Group ◽  
Third Party ◽  
Primary Care Centre ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Care Centre ◽  
Reduction Of Pain

BACKGROUND Pain and anxiety caused by vaccination and other medical procedures in childhood can cause discomfort for both the patient and their parents. Virtual reality (VR) is a technology capable of entertaining and distracting the user. Among its many applications, we find the improvement of pain management and the reduction of anxiety in patients undergoing medical interventions. OBJECTIVE Reduction of pain and anxiety after the administration of two vaccines in children aged 3 to 6 years. METHODS Randomized, parallel, controlled clinical trial with two assigned groups. The intervention group will wear virtual reality goggles during the administration of two vaccines, while the control group will receive standard primary care centre care for the procedure. Randomization will be carried out using the "RandomizedR" computer system, a randomization tool of the R Studio program. This is an open or unblinded trial, both the subject and the investigator will know the assigned treatment group. Due to the nature of the VR intervention, it is impossible to blind patients, caregivers or observers. However, a blind third party assessment will be carried out. The study population focuses on children aged 3 to 6 years, included in the patient registry and cared for in the primary care centre of the region of Central Catalonia, who will receive the following vaccines during the well child check-up: triple viral + varicella at 3 years of age and hepatitis A + Diphtheria-Tetanus-Pertussis at 6 years of age. RESULTS The study is scheduled to begin in January 2022 and is scheduled to end in January 2023 when the statistical analysis will begin. CONCLUSIONS Virtual reality can be a useful tool in paediatric procedures that generate pain and anxiety. CLINICALTRIAL The clinical trial has been approved by the IDIAP Jordi Gol i Guirna ethics committee with code 4R21/061.

Adverse selection and moral hazard in the provision of clinical trial ancillary care

2012 ◽  
Vol 8 (2) ◽  
pp. 225-234 ◽  
Author(s):  
Michael R. Richards ◽  
Lorens A. Helmchen
Keyword(s):  
Clinical Trial ◽  
Moral Hazard ◽  
Medical Care ◽  
Adverse Selection ◽  
Financial Risk ◽  
Third Party ◽  
Care Utilization ◽  
Insurance Benefit ◽  
Ancillary Care ◽  
Study Participants

AbstractAs more and more clinical trials are conducted in developing countries, concerns arise about non-trial medical care available to study participants. Recent work argues for ancillary care – medical care not part of the clinical trial per se – to be formally incorporated into these studies. Although the provision of ancillary care is often justified on ethical grounds, a number of crucial implementation issues remain unresolved, including its scope, duration and financing. Drawing on lessons from health insurance benefit design, we highlight two overlooked challenges for ancillary care adoption – adverse selection and moral hazard – and offer recommendations that could attenuate their consequences. Specifically, adverse selection and moral hazard could be reduced by offering a choice between ancillary medical care and monetary compensation or rewarding low ancillary care utilization. Alternatively, researchers’ financial risk due to ancillary care could be shifted to a third-party insurer. Recognizing participants’ behavioral responses to prospective offers of ancillary medical care would allow funders and research teams to forecast the demand for ancillary care more accurately and to prepare for its provision more adequately.

scholarly journals Double-Unit Cord Blood (CB) Transplantation with Haplo-Identical CD34+ Cells (haplo-dCBT) May Speed Neutrophil Recovery Although Successful Bridging Is Contingent on Close Haplo-Winning CB Unit HLA-Match

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 2078-2078
Author(s):  
Ioannis Politikos ◽  
Sean M Devlin ◽  
Christopher Mazis ◽  
Molly Maloy ◽  
Kristine Naputo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Aplastic Anemia ◽  
Research Funding ◽  
Ex Vivo ◽  
Univariate Analysis ◽  
Third Party ◽  
Acute Leukemias ◽  
Platelet Recovery ◽  
Neutrophil Recovery ◽  
Cell Dose

Abstract Background : While dCBT is associated with high rates of sustained donor engraftment, delayed neutrophil recovery in adults is frequent and can contribute to extended hospitalization and early transplant-related mortality. Methods : We investigated engraftment after myeloablative dCBT supplemented with CD34+ selected haploidentical PBSC (haploCD34+) in patients (pts) with high risk hematologic malignancies or aplastic anemia in a phase II clinical trial. The aim was to abrogate neutropenia (ANC >/= 500 within 14 days) with a haplo myeloid bridge prior to CB engraftment. Pts did not receive ATG due to the increased mortality risk reported in adult CBT. Double unit CB grafts allowed comparison to dCBT controls without haploidentical graft supplementation. Results : 78 adult pts [median age 48.5 years (range 21-68), median weight 82 kgs (range 48-138), 44 (56%) CMV+, 3 with prior allografts] underwent haplo-dCBT between 9/2012-12/2017. Diagnoses included 54 (69%) acute leukemias, 10 (13%) MDS/ MPN (all ≤ 10% blasts at work-up), 10 (17%) NHL/ HD and 1 aplastic anemia. Conditioning was myeloablative (1 Cy 120/ Flu 75/ TBI 1375, 77 intermediate intensity Cy 50/ Flu 150/ Thio 5-10/ TBI 400) with CSA/ MMF. CB units had a median infused TNC of 2.3 (range 1-5.7) x 107/kg/unit & median infused viable CD34+ cell dose of 1.1 (range 0.1-3.1) x 105/kg/unit with a median 5/8 (range 2-7) unit-recipient HLA-allele match. Haplo CD34+ grafts [procured from children (46%), siblings (31%), parents (13%) or extended family (10%)] had a median infused CD34+ dose of 5.2 x 106/kg (range 1.1-16.8) and a median infused CD3+ dose of 1.6 x 103/kg (range 0.3-13.7). Sixty-one (78%) haplos were 4/8 and 17 (22%) were 5-7/8 HLA-matched to the pt. In 77 evaluable pts (1 pt died on day 14), 4 engraftment patterns were observed (Table 1). All but 2 pts had sustained CB engraftment with either an optimal haplo-bridge (Gp. 1, 34/77, 44%), a transient bridge with a second nadir preceding CB engraftment (Gp. 2, 20/77, 26%), or no bridge (Gp. 3, 21/77, 27%). The 2 remaining pts had CB/ haplo graft failure (Gp. 4, 2/77, 3%); both were successfully re-transplanted with single CB units. While there was no difference in the day 100 TRM in the 34 optimal bridge pts vs pts with transient or no bridge [9% (95%CI 2-21) vs 15% (95%CI 6-27), p = 0.388], optimal bridge pts had faster platelet recovery [19 (range 14-41) vs 44.5 days (range 14-67)] and earlier hospital discharge [28.5 (range 20-60) vs 36 days (range 28-98)]. Similar to dCBT alone, chimerism analysis revealed sustained engraftment in haplo-dCBT is mediated by a "winning" CB unit. This was heralded by winning unit-derived T-cells seen as early as day +28. Although universal, the speed of haplo rejection varied, and a high haplo chimerism percentage early post-transplant did not guarantee successful bridging. Analysis of factors potentially predicting an optimal bridge is shown in Table 2. The median winning CB unit-haplo 8-allele HLA-match was 3/8 (range 1-7/8). In univariate analysis, higher haplo CD34+ dose/kg, > 4/8 haplo-recipient HLA-match and ≥ 3/8 winning unit-haplo HLA-match were associated with a higher likelihood of bridging. Haplo CD34+ dose and winning unit-haplo HLA-match remained significant in multivariate analysis. Conclusions: While haplo-dCBT can be associated with enhanced neutrophil recovery, this platform does not guarantee a successful myeloid bridge due to early haplo rejection by the winning CB unit. This universal haplo rejection highlights the importance of the CB graft dose and quality with this ATG-free strategy as the CB will mediate sustained engraftment. Our findings have significance for strategies that combine unmanipulated CB with any third-party or ex vivo expanded T-cell depleted product given higher product CD34+ cell dose and better HLA-match to the unmanipulated CB unit could improve the likelihood of successful myeloid bridging. The data also support alternative approaches to improve myeloid recovery after CBT such as optimized unit selection and vivo expansion. Disclosures O'Reilly: Atara Biotherapeutics: Consultancy, Patents & Royalties, Research Funding. Perales:Takeda: Other: Personal fees; Novartis: Other: Personal fees; Incyte: Membership on an entity's Board of Directors or advisory committees, Other: Personal fees and Clinical trial support; Merck: Other: Personal fees; Abbvie: Other: Personal fees. Sauter:Juno Therapeutics: Consultancy, Research Funding; Sanofi-Genzyme: Consultancy, Research Funding; Spectrum Pharmaceuticals: Consultancy; Novartis: Consultancy; Precision Biosciences: Consultancy; Kite: Consultancy. Shah:Janssen: Research Funding; Amgen: Research Funding.

scholarly journals A Phase I Clinical Trial Testing the Safety of IL-21-Expanded, Universally Alloreactive Donor-Derived Natural Killer Cells for Relapsed/Refractory Acute Myeloid Leukemia and Myelodysplastic Syndrome

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 1732-1732
Author(s):  
Sumithira Vasu ◽  
Nidhi Sharma ◽  
Alison R. Walker ◽  
Sarah A Wall ◽  
James S. Blachly ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Nk Cells ◽  
Board Of Directors ◽  
Dose Level ◽  
Research Funding ◽  
Nk Cell ◽  
Third Party ◽  
Advisory Committees ◽  
Refractory Aml

Abstract Background: Natural Killer (NK) cells are cytotoxic lymphocytes that are able to exert an anti-tumor effect in an MHC-I independent manner, but are dysfunctional and reduced in number in patients with leukemia. Several studies have shown therapeutic potential for related donor NK cells expanded and/or activated ex vivo when administered to cancer patients, including patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). However, personalized, donor-derived cell therapies require time for donor identification, manufacturing and product release, resulting in patient attrition. As NK alloreactivity and NKG2C expression play critical roles in mediating anti-tumor effects, we identified 'ideal' NK cell donors (in partnership with "Be the Match Biotherapies") for collection. Human leukocyte antigen (HLA) and Killer immunoglobulin receptor (KIR) genotyping were done to screen and select donors. Following this, a sample was collected from donors to expand NK cells under small-scale conditions. If donor NK cells showed robust expansion, they proceeded with apheresis. To ensure these therapeutic cells would be readily-available, we established a third-party NK cell bank through scalable, affordable mass-production with membrane-bound IL-21 feeder cells (FC21), and cryopreserved large numbers of these NK cells for immediate 'off-the-shelf' administration to recipients. Here, we report our initial experience in a Phase I trial of these off-the-shelf (OTS) alloreactive NK cells as immunotherapy for patients with relapsed/refractory AML and MDS. Methods: Patients were treated at Dose level 1, to allow infusion at a dose of 1 x 10e7 NK cells/ kg. Each dose level had two cohorts, stratified by age. Patients were enrolled into Cohort 1 (patients &lt;60 yrs. received Fludarabine (Flu) 30 mg/m2/day & Cytarabine 2 g/m2/day on days -6 to -2) and Cohort 2 (patients ≥ 60 yrs. received Flu 30 mg/m2/day (days -5 to -2) & Decitabine 20 mg/m2/day (days -6 to -2). Patients were evaluated to see if they had any donor-directed antibodies. After chemotherapy, NK cells were infused thrice weekly for 6 doses, to be given over a period of 2 weeks (Clinicaltrials.gov: NCT04220684). Persistence of donor NK cells was determined by flow cytometry using haplotype-discriminating anti-HLA antibodies (Figure 1, 2). NK cells were completely HLA-mismatched between donor and recipients. Results: 6 patients (3/cohort) were treated at the first dose level of 1x10 7 NK cells/kg/dose. All 6 patients had relapsed/refractory AML and had received at least two prior lines of treatment. One patient (005) withdrew from the study prior to infusion of NK cells. 6 patients received the first NK cell dose as an inpatient and were discharged to receive the remaining 5 doses as an outpatient. 5 patients tolerated infusion of all 6 doses of NK cells administered over 2 weeks. One patient (006) developed a Cytokine response (CRS) - like syndrome in the context of streptococcus bacteremia and received only one dose of NK cells. Symptoms suggestive of CRS responded fully with steroids and patient was able to successfully wean off steroids and discharged to the outpatient setting. One patient proceeded to allogeneic hematopoietic cell transplant. No infusion-related reactions, neurotoxicity or graft versus host disease was observed. In vivo persistence/expansion NK cells were superior with FLU/CY lymphodepletion (cohort 1). Conclusions: Cryopreserved, third-party donor-derived NK cells are safe and feasible in relapsed/refractory AML patients, and even at this first dose level, completely HLA-mismatched NK cells can persist and expand to high levels in vivo. Figure 1 Figure 1. Disclosures Vasu: Kiadis, Inc.: Research Funding; Seattle Genetics: Other: travel support; Boehringer Ingelheim: Other: Travel support; Omeros, Inc.: Membership on an entity's Board of Directors or advisory committees. Walker: Newave: Other: clinical trial support; Geron: Other: clinical trial support; Novartis: Other: clinical trial support. Blachly: INNATE: Consultancy, Honoraria; KITE: Consultancy, Honoraria; AbbVie: Consultancy, Honoraria; AstraZeneca: Consultancy, Honoraria. de Lima: Incyte: Membership on an entity's Board of Directors or advisory committees; Pfizer: Membership on an entity's Board of Directors or advisory committees; BMS: Membership on an entity's Board of Directors or advisory committees; Miltenyi Biotec: Research Funding. Lee: Kiadis Pharma: Divested equity in a private or publicly-traded company in the past 24 months, Honoraria, Membership on an entity's Board of Directors or advisory committees, Patents & Royalties, Research Funding; Courier Therapeutics: Current holder of individual stocks in a privately-held company.

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