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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 90
Healthy Volunteers: f
View:

• 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×ULN. If Gilbert syndrome is diagnosed, the total bilirubin index can be relaxed to ≤3.0×ULN and the direct bilirubin ≤1.5×ULN.

• No serious mental disorders;

• Can understand this test and has signed the informed consent.

Locations
Other Locations
China
District One Hospital
RECRUITING
Beijing
Contact Information
Primary
Rhoda M Smith, Phd
clinical-trials@essen-biotech.com
+12077706670
Time Frame
Start Date: 2025-04-29
Estimated Completion Date: 2028-12-28
Participants
Target number of participants: 60
Treatments
Experimental: CD19/GPRC5D CAR T cells, chemotherapy
Patients will be administered fludarabine phosphate intravenously (IV) over a 30-minute period on days -4 to -2. Additionally, cyclophosphamide will be administered intravenously (IV) over 60 minutes on day -2. Subsequently, patients will receive BCMA/GPRC5D CAR T cells intravenously (IV) over a duration of 10-20 minutes on day 0. Patients who exhibit positive responses to the initial dose of BCMA/GPRC5D CAR T cells, do not experience unacceptable side effects, and have a sufficient quantity of cells available may be eligible to receive 2 or 3 additional doses of BCMA/GPRC5D CAR T cells.
Sponsors
Leads: Essen Biotech

This content was sourced from clinicaltrials.gov