LIGHT-PSMA-CART in Treating Patients With Castrate-Resistant Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04053062|
Recruitment Status : Suspended (Due to efficacy evaluation)
First Posted : August 12, 2019
Last Update Posted : April 11, 2022
|Condition or disease||Intervention/treatment||Phase|
|Castrate-Resistant Prostate Cancer||Biological: LIGHT-PSMA-CART cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||3 x 10^6/ KgBW; 6 x 10^6/ KgBW|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study to Evaluate the Safety and Efficacy of PSMA-CART Co-expressing LIGHT in Treating Patients With Castrate-Resistant Prostate Cancer (CRPC)|
|Actual Study Start Date :||July 16, 2020|
|Estimated Primary Completion Date :||November 15, 2022|
|Estimated Study Completion Date :||December 30, 2023|
Patients undergo leukapheresis. Patients then receive cyclophosphamide and fludarabine on days -6 to -4. Patients receive LIGH-PSMA-CART IV at split doses from day 0 on.
Biological: LIGHT-PSMA-CART cells
LIGHT-PSMA-CART cells will be given IV at split doses
Other Name: Autologous PSMA-specific chimeric antigen cells co-expressing LIGHT
- Incidence of toxicity graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 [ Time Frame: 28 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.
- PSA response rate [ Time Frame: 24 weeks ]proportion of patients with ≥50% PSA decline from baseline at any time point after therapy and maintained for ≥4 weeks
- Radiographic response rate by RECIST 1.1 & PCWG3. [ Time Frame: 24 weeks ]Proportion of patients with a best response of either complete response or partial response, assessed using Prostate Cancer Working group3(PCWG3) response criteria &RECIST 1.1.
- 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
|Shanghai, Shanghai, China, 200433|
|Principal Investigator:||Shancheng Ren, Professor||Changhai Hospital|