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Clinical Trial Summary

A Phase 1/2 Open label, multicenter, clinical trial of autologous CAR T-cell therapy targeting GPRC5D, in participants with relapsed/refractory multiple myeloma or relapsed/refractory primary plasma cell leukemia.


Clinical Trial Description

This is an open-label, multicenter, Phase 1/2 trial of CT071 in adult participants with relapsed or refractory multiple myeloma (RRMM) or relapsed or refractory primary plasma cell leukemia (RRpPCL). The study will be conducted in two phases. Phase 1 of the study will be dose escalation followed by dose expansion. After recommended Phase 2 dose is identified in Phase 1, the enrollment of Phase 2 will start. Following consent, enrolled subjects will undergo apheresis to collect cells for manufacture of the CAR-T cells. Following the manufacture of the CAR-T cells, subjects will receive lymphodepletion prior to CAR T-cell infusion. All subjects who complete the study, as well as those who withdraw from the study after receiving CAR T-cell infusion for reasons other than death or meeting the early termination criteria, will be asked to undergo a 15-year long-term follow-up. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06333509
Study type Interventional
Source CARsgen Therapeutics Co., Ltd.
Contact CARsgen US
Phone CentralNumber
Email clinicalUS@carsgen.com
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date April 15, 2024
Completion date December 31, 2027

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