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Recruiting Phase 1, Phase 2 NCT07032129

Sequential CAR-T Cells Targeting BCMA/GPRC5D in Patients With Relapsed/ Refractory Multiple Myeloma

Trial Parameters

Condition Multiple Myeloma
Sponsor Essen Biotech
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 60
Sex ALL
Min Age 21 Years
Max Age 90 Years
Start Date 2025-04-29
Completion 2027-12-10
Interventions
BCMA/GPRC5D CAR-T cells

Brief Summary

This is an open, single-arm, clinical study to evaluate the efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) targeting BCMA or GPRC5D or both sequentially in the treatment of Relapsed/ Refractory Multiple myeloma

Eligibility Criteria

Inclusion Criteria: * Expected survival time ≥3 months; * Subjects with recurrent/refractory Multiple Myeloma who have failed standard treatment or lack effective treatment, Including but not limited to systemic lupus erythematosus, idiopathic inflammatory myopathy, systemic sclerosis, IGG4-associated diseases, primary Sjogren's syndrome, rheumatoid arthritis, connective tissue disease-associated interstitial lung disease, immune thrombocytopenia, primary biliary cholangitis, etc. * Histological evidence of non-suppurative destructive cholangitis and small bile duct destruction. * Liver and kidney function, cardiopulmonary function meet the following requirements: * Creatinine ≤1.5×ULN; (2) Electrocardiogram showed no clinically significant abnormal bands; * Blood oxygen saturation \>91% in non-oxygen state; * Total bilirubin ≤2×ULN; ALT and AST≤2.5 x ULN; ALT and AST abnormalities due to disease, such as liver infiltration or bile duct obstruction, were determined to be less than 5×UL

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