A Study of CAR-T Cells Targeting GPRC5D in the Treatment of r/r Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT05016778|
Recruitment Status : Active, not recruiting
First Posted : August 23, 2021
Last Update Posted : November 1, 2022
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: GPRC5D-CAR-T||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Arm, Open Label Clinical Study of CAR-T Cells Targeting GPRC5D in the Treatment of Relapsed / Refractory Multiple Myeloma(POLARIS)|
|Actual Study Start Date :||June 8, 2021|
|Estimated Primary Completion Date :||June 30, 2024|
|Estimated Study Completion Date :||June 30, 2025|
Experimental: Treatment Group
This is a open label, single arm clinical trial.
After enrollment, subjects complete the PBMC apheresis, then complete the Lymphocyte clearance, and then receive the dose climbing test: 1×10e6/kg，3×10e6/kg，6×10e6/kg.
- Dose limited toxicity (DLT) [ Time Frame: From date of initial treatment to Day 28 post GPRC5D CAR-T infusion. ]Dose limited toxicity
- AE and SAE [ Time Frame: From admission to the end of the follow-up, up to 2 years ]Adverse event and serious adverse event
- Concentration of CAR-T cells [ Time Frame: From admission to the end of the follow-up, up to 2 years ]In peripheral blood and bone marrow
- Objective Response Rate, ORR [ Time Frame: In 3 months of GPRC5D CAR-T cell infusion ]Proportion of subjects with complete or partial remission
- Disease control rate, DCR [ Time Frame: From Day 28 GPRC5D CAR-T infusion up to 2 years ]The percentage of patients with remission and stable disease after treatment in the total evaluable cases.
- Duration of remission, DOR [ Time Frame: 24 months post GPRC5D CAR-T cells infusion ]The time from the first assessment of remission or partial remission of the tumor to the first assessment of disease progression or death from any cause;
- Progression-free survival, PFS [ Time Frame: 24 months post GPRC5D CAR-Tcells infusion ]The time from cell reinfusion to the first assessment of tumor progression or death from any cause
- Overall survival, OS [ Time Frame: From GPRC5D CAR-T infusion to death，up to 2 years ]The time from the cell reinfusion to death due to any cause.
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): NCT05016778
|The first affiliated hospital of medical college of zhejiang university|
|Hangzhou, Zhejiang, China, 310003|
|Principal Investigator:||Huang He||Hematology|