PSMA-CART in Treating Patients With Refractory Castrate-Resistant Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT04053062|
Recruitment Status : Recruiting
First Posted : August 12, 2019
Last Update Posted : August 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Castrate-Resistant Prostate Cancer||Biological: PSMA-CART cells||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||0.5-1 x 10^7/ KgBW; 3-6 x 10^7/ KgBW|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study to Evaluate the Safety and Efficacy of PSMA-CART in Treating Patients With Refractory Castrate-Resistant Prostate Cancer (CRPC)|
|Actual Study Start Date :||August 8, 2019|
|Estimated Primary Completion Date :||August 10, 2020|
|Estimated Study Completion Date :||August 2022|
Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -6 to -4. Patients receive PSMA-specific CAR-expressing T lymphocytes IV over on day 0.
Biological: PSMA-CART cells
PSMA-CART cells will be given IV on day 0 over 20-30 mins
Other Name: Autologous PSMA-specific chimeric antigen cells
- 2. Incidence of toxicity graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 [ Time Frame: 35 days ]All adverse events (AEs) will be listed and summarized. Summaries of laboratory data will include, at a minimum, treatment-emergent laboratory abnormalities. Summaries of AEs and laboratory abnormalities will be based on the All Treated analysis set.
- Objective response rate (ORR) [ Time Frame: 24 weeks ]Proportion of patients with a best response of either complete response or partial response, assessed using Prostate Cancer Working group(PCWG) response criteria.
- Duration time of CART cells in vivo [ Time Frame: 24 weeks ]Number of persistent PSMA-CART cells detected by Q-PCR or flow cytometry
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04053062
|Contact: Wei Li, PhDfirstname.lastname@example.org|
|Shanghai, Shanghai, China, 200433|
|Contact: Shancheng Ren, Professor|
|Principal Investigator: Shancheng Ren, PhD|
|Principal Investigator:||Shancheng Ren, Professor||Changhai Hospital|