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BCMA CAR-T in Relapsed/Refractory Multiple Myeloma
NCT05594797Phase 2
Key facts
- Status
- Recruiting
- Start
- Jul 2022
- Primary completion
- Jul 2025
- Countries
- 1
- Sponsor
- Shanghai HRAIN Biotechnology
- Modality
- CAR-T Cells
- Drugs
- HRC0202
- Conditions
- multiple myeloma (MM)
01
Overview
Phase 2, open-label, single-arm trial of HRC0202 in multiple myeloma (MM), sponsored by Shanghai HRAIN Biotechnology. Primary endpoint: Objective Response Rate at 3 months. Started Jul 2022; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Human BCMA Targeted T Cells Injection
Single infusion of BCMA CAR-T cells following lymphodepletion
03
Who it enrols
Patients with relapsed/refractory multiple myeloma aged 18-75 who have received at least 3 prior lines of therapy (including a proteasome inhibitor and an immunomodulator) and have not received prior CAR-T or BCMA-targeted therapy. Patients must have adequate organ function and no CNS disease.
04
Endpoints
Primary
Objective Response Rate
Secondary
Duration of Remission
Progression-Free Survival
Overall Survival
Objective Response Rate
Percentage of Subjects With Negative Minimal Residual Disease
Number of Subjects with Adverse Events
Occurrence rate of adverse events grade >= 3
Maximum CAR level in peripheral blood or bone marrow
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