BCMA CAR-T Cell Therapy in High-risk NDMM Patients With Positive MRD After First-line ASCT (NCT05846737) | Clinical Trial Compass
WithdrawnPhase 2
BCMA CAR-T Cell Therapy in High-risk NDMM Patients With Positive MRD After First-line ASCT
Stopped: The study was withdrawn due to the inability to enroll participants.
China0Started 2023-05-29
Plain-language summary
This study is a open-label, single-center Phase 2 study to evaluate the efficacy and safety of BCMA CAR-T Cell Therapy in High-risk NDMM Patients With Positive MRD After First-line ASCT. A total of 40 subjects will be enrolled into this study.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years.
✓. Participants with documented NDMM according to IMWG diagnostic criteria.
✓. High-risk MM, as determined by R2-ISS（J Clin Oncol, 2022,40(29):3406-3418.）, Stage III or Stage IV.
✓. Has received 3 to 6 cycles of induction therapy, followed by conditioning regimen and ASCT.
✓. Screening must be completed within 100 days of ASCT.
✓. For subjects receiving consolidation therapy after ASCT, screening must be completed within 60 days after consolidation therapy, and within 6 months after ASCT.
✓. Detectable MRD using EuroFlow or NGS, at 100 days after ASCT (minimum sensitivity of 10-5).
✓. All screening blood biochemistry: tests should be performed according to the protocol and within 14 days before enrollment. Screening laboratory values must meet the following criteria: a.TBIL\<1.5 x upper limit of normal (ULN) (\<3 x ULN in patients with Gilbert's syndrome); b.AST and ALT \<3 x ULN.; c. Creatinine clearance \> 60mL/min (calculated using the Cockroft-Gault formula).
Exclusion criteria
✕. Primary plasma cell leukemia.
✕. Documented active amyloidosis.
✕. Multiple myeloma with central nervous system (CNS) invasion.
✕
What they're measuring
1
Safety and Tolerability
Timeframe: Up to 2 year
2
MRD-negativity rate
Timeframe: 3 months after CAR-T cell infusion
Trial details
NCT IDNCT05846737
SponsorInstitute of Hematology & Blood Diseases Hospital, China
✕. Prior exposure to any BCMA-targeted therapy or CAR-T therapy.
✕. Patients with peripheral neuropathy greater than grade 2 or peripheral neuropathy greater than grade 2 with pain at baseline, regardless of whether they were currently receiving medical therapy.
✕. Known intolerance, hypersensitivity, or contraindication to BCMA-CART cellular products.
✕. Seropositive for human immunodeficiency virus (HIV).