scholarly journals Safety and Efficacy of Vacuum Bottle Plus Catheter for Drainage of Iatrogenic Pneumothorax

2021 ◽  
Author(s):  
Shih-Yu Chen ◽  
Yao-Wen Kuo ◽  
Chao-Chi Ho ◽  
Huey-Dong Wu ◽  
Hao-Chien Wang
Keyword(s):  
Clinical Trial ◽  
Median Duration ◽  
Related Complication ◽  
Catheter Drainage ◽  
Initial Management ◽  
Efficient Procedure ◽  
Safety And Efficacy ◽  
Median Size ◽  
Duration Of Hospitalization ◽  
Tunneled Catheter

Abstract Iatrogenic pneumothorax is common after thoracic procedures. For pneumothorax larger than 15%, simple aspiration is suggested. This clinical trial (NCT03724721) assessed the safety and efficacy of vacuum bottle plus non-tunneled catheter air drainage, which has long been performed in many institutions. From August 2018 to February 2020, patients older than 20 years of age who developed iatrogenic pneumothorax were prospectively enrolled. Totally 21 patients underwent vacuum bottle plus catheter drainage. The median size of pneumothorax was 19.6%, as measured by Rhea’s method. Of the 21 patients, 15 had successful air drainage, and the remaining 6 patients required subsequent pigtail placement. The end-expiratory intrapleural pressure of all patients remained less than -20 cmH2O during drainage. The median duration of hospitalization was 2 (interquartile range [IQR], 1-4) days. No procedure-related complication was observed. A retrospective analysis of patients who received conservative treatment showed that the median duration of hospitalization was longer in patients with larger pneumothorax (1 day vs. 5 days [IQR, 1-1 day vs. 3-7 days]). This study showed that vacuum bottle plus catheter drainage of iatrogenic pneumothorax is a safe and efficient procedure. It is recommended as initial management of stable iatrogenic pneumothorax with size larger than 15%.

Safety and efficacy of a novel anti-CD20/CD19 bi-specific CAR T-cell therapy (C-CAR039) in relapsed or refractory (r/r) B-cell non-Hodgkin lymphoma (B-NHL).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 2507-2507
Author(s):  
Aibin Liang ◽  
Lili Zhou ◽  
Ping Li ◽  
Wenjuan Yu ◽  
Min Yang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Median Time ◽  
Median Duration ◽  
Conditioning Regimen ◽  
Early Clinical Trial ◽  
Safety And Efficacy ◽  
Car T ◽  
Duration Of Response ◽  
Grade 3

2507 Background: C-CAR039 has been developed as a novel 2nd generation 4-1BB bi-specific CAR-T targeting both CD19 and CD20 antigens with an optimized bi-specific antigen binding domain. C-CAR039 can eradicate CD19/CD20 single or double positive tumor cells in vitro and in vivo. The tissue cross reactivity and whole genome membrane proteome array studies further confirmed the specificity of C-CAR039. Methods: GMP manufacturing of C-CAR039 was carried out in a serum free and fully closed semi-automatic system. Dose escalation and expansion studies were conducted to evaluate the safety and efficacy of C-CAR039 in r/r B-NHL patients. C-CAR039 was administered as a single intravenous dose after a 3-day cyclophosphamide plus fludarabine conditioning regimen. Results: As of 1/31/2021, 28 patients were infused and 25 (DLBCL, n = 22; PMBCL, n = 1; tFL, n = 1; FL, n = 1) were evaluable for safety and efficacy at dose ranges of 1.0 x 106 to 5.0x106 CAR-T cells/kg. The median age was 54 (range, 28-71) years, median number of prior lines of therapy was 3 (range, 1–5), 76% (19/25) of patients were in Ann Arbor Stage III/IV, and 80% (20/25) were refractory to their last treatment. 5 patients (20%) received bridging therapy. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were graded according to ASTCT 2019 criteria. Of the 25 patients, 24 (96%) experienced CRS, 23 (92%) were grade 1 or 2, 1 patient was grade 3. Median time to onset of CRS was 3 days (range, 0-10), with median duration of 4 days (range, 1-25). 2 patients had a grade 1 ICANS. Grade≥3 neutropenia, anemia, thrombocytopenia and infection were reported in 88%, 40%, 16% and 0% of patients, respectively. The best overall response rate was 92%, complete response (CR) rate was 84% and median time to response was 1.0 month (range, 0.9-1.2). With a median follow-up of 5.3 months, 76% remained in CR. Kaplan Meyer estimation of PFS at 6 months was 87.3% (95% CI, 71.2 to 100.0). Median duration of response has not been reached. Furthermore, C-CAR039 showed an encouraging cellular kinetic profile. In 25 evaluable patients, the median Tmax was 11 day, the median Cmax was 139,497 copies/mg gDNA, and the median AUC0̃28DAY of 1,673,844 day*copies/μg gDNA. Conclusions: C-CAR039 demonstrated a favorable safety profile and promising efficacy in this early clinical trial in patients with r/r B-NHL that might allow it to differentiate from existing therapies. The early clinical efficacy signal is encouraging and compares favorably to anti-CD19 CAR-T and peer therapies. These findings will be evaluated in more patients with longer follow-up to confirm safety, efficacy and duration of response. Clinical trial information: NCT04317885 , NCT04655677 , NCT04696432 , NCT04693676 .

Safety and efficacy of a novel anti-CD20 chimeric antigen receptor (CAR)-T cell therapy in relapsed/refractory (r/r) B-cell non-Hodgkin lymphoma (B-NHL) patients after failing CD19 CAR-T therapy.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 2508-2508
Author(s):  
Aibin Liang ◽  
Shiguang Ye ◽  
Ping Li ◽  
Jiaqi Huang ◽  
Shigui Zhu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Median Time ◽  
Median Duration ◽  
Chimeric Antigen Receptor ◽  
Antigen Receptor ◽  
Cell Transplant ◽  
Bridging Therapy ◽  
Safety And Efficacy ◽  
Medical Need ◽  
Car T

2508 Background: Relapse due to loss of the CD19 targeted epitope presents a therapeutic challenge of CD19 CAR-T therapy. These patients universally have a poor outcome and the unmet medical need is high. CD20 is a proven therapeutic target for B-NHL, supported by approved and widely used monoclonal antibody therapy. C-CAR066 is a novel 2nd generation chimeric antigen receptor T (CAR-T) therapy targeting CD20 antigen. Preclinical studies suggest that C-CAR066 has superior anti-tumor activity compared to CAR-Ts derived from scFVs of Leu16, Rituximab and Obinutuzumab and anti-CD19 BBZ CAR with FMC63. Methods: A phase I clinical trial (NCT04036019) was conducted to evaluate the safety and efficacy of C-CAR066 in subjects with r/r B-NHL who were previously treated with anti-CD19 CAR-T therapy. Patients (≥ 18 years) with r/r DLBCL, r/r FL or r/r MCL, ECOG < 2 were eligible. GMP manufacture of C-CAR066 was in a serum free and fully closed semi-automatic system. A 3-day cyclophosphamide plus fludarabine regimen was followed by a single infusion of C-CAR066. Bridging therapy was allowed. Results: As of Jan 31, 2021, 7 patients (6 DLBCL, 1 tFL) were enrolled and infused with C-CAR066 at dose ranges of 2.0 x 106 to 4.8x106 CAR-T cells/kg. The manufacturing success rate was 100%. The median age was 51 (range, 41-62) years, and 42.9% (3/7) patients were male. The median number of prior lines of therapy was 5 (range, 2-6). One patient (14.3%) underwent autologous stem cell transplant (ASCT) and one patient received bridging therapy. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were graded according to ASTCT 2019 criteria. All 7 patients experienced CRS and most (85.7%) were grade 1 or 2. One patient had grade 4 CRS and recovered after treatment with tocilizumab and corticosteroids. Median time to onset of CRS was 5 days (range, 1-9), with median duration of 4 days (range, 2-17). There were no episodes of ICANS. Grade ≥3 neutropenia, anemia, thrombocytopenia, and infections were reported in 57.1%, 42.9%, 28.6%, and 14.3% of patients, respectively. At a median follow-up of 7.8 months, the best overall response rate was 100%, with 71.4% (5/7) achieving complete response (CR). Median time to response was 1.0 month (range, 0.9-2.7). Median time to CR was 2.7 months (range, 0.9-2.8). By the cutoff date, 3 patients (2 PR, 1 CR) had disease progression. Median duration of response was not reached. Conclusions: C-CAR066 has shown a favorable safety profile and promising efficacy in patients with r/r B-NHL following failure of CD19 CAR-T therapy. These results show that C-CAR066 has a different mechanism of action compared to anti-CD-19 CAR-T therapy and could provide a solution to address the unmet medical need in B-NHL patients that have failed anti-CD19 CAR-T therapy. Clinical trial information: NCT04036019.

scholarly journals Platform study of genotyping-guided precision medicine for rare solid tumours: a study protocol for a phase II, non-randomised, 18-month, open-label, multiarm, single-centre clinical trial testing the safety and efficacy of multiple Chinese-approved targeted drugs and PD-1 inhibitors in the treatment of metastatic rare tumours

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e044543
Author(s):  
Shuhang Wang ◽  
Hui-Yao Huang ◽  
Dawei Wu ◽  
Hong Fang ◽  
Jianming Ying ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Targeted Therapy ◽  
Single Agent ◽  
Solid Tumours ◽  
Targeted Drugs ◽  
Gene Fusions ◽  
Single Centre ◽  
Open Label ◽  
Safety And Efficacy ◽  
Rare Tumours

IntroductionLimited clinical studies have been conducted on rare solid tumours, and there are few guidelines on the diagnosis and treatment, including experiences with targeted therapy and immunotherapy, of rare solid tumours in China, resulting in limited treatment options and poor outcomes. This study first proposes a definition of rare tumours and is designed to test the preliminary efficacy of targeted and immunotherapy drugs for the treatment of rare tumours.Methods and analysisThis is a phase II, open-label, non-randomised, multiarm, single-centre clinical trial in patients with advanced rare solid tumours who failed standard treatment; the study aims to evaluate the safety and efficacy of targeted drugs in patients with advanced rare solid tumours with corresponding actionable alterations, as well as the safety and efficacy of immune checkpoint (programmed death receptor inhibitor 1, PD-1) inhibitors in patients with advanced rare solid tumours without actionable alterations. Patients with advanced rare tumours who fail standardised treatment and carry actionable alterations (Epidermal growth factor receptor (EGFR) mutations, ALK gene fusions, ROS-1 gene fusions, C-MET gene amplifications/mutations, BRAF mutations, CDKN2A mutations, BRCA1/2 mutations, HER-2 mutations/overexpressions/amplifications or C-KIT mutations) will be enrolled in the targeted therapy arm and be given the corresponding targeted drugs. Patients without actionable alterations will be enrolled in the PD-1 inhibitor arm and be treated with sintilimab. After the patients treated with vemurafenib, niraparib and palbociclib acquire resistance, they will receive combination treatment with sintilimab or atezolizumab. With the use of Simon’s two-stage Minimax design, and the sample size was estimated to be 770. The primary endpoint of this study is the objective response rate. The secondary endpoints are progression-free survival in the targeted treatment group and single-agent immunotherapy group; the duration of response in the targeted therapy and single-agent immunotherapy groups; durable clinical benefit in the single-agent immunotherapy group; and the incidence of adverse events.Ethics and disseminationEthics approval was obtained from the Chinese Academy of Medical Sciences (ID: 20/132-2328). The results from this study will be actively disseminated through manuscript publications and conference presentations.Trial registration numbersNCT04423185; ChiCTR2000039310.

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