Status:
RECRUITING
A Clinical Study to Evaluate the Safety and Efficacy of BCMA-GPRC5D CAR-T in Patients With Relapsed/Refractory Multiple Myeloma Who Received Three or More Lines of Therapy
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborating Sponsors:
Guangzhou Bio-gene Technology Co., Ltd
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of bispecific BCMA-GPRC5D Chimeric antigen receptor (CAR) T-cells in patients with relapsed or refractory mult...
Detailed Description
B-cell maturation antigen (BCMA)-targeted Chimeric antigen receptor (CAR) T-cell therapy has yielded satisfactory clinical outcomes in patients with relapsed or refractory (R/R) multiple myeloma (MM)....
Eligibility Criteria
Inclusion
- Patient or his or her legal guardian voluntarily participates in and signs an informed consent form;
- Aged ≥ 18 years and ≤ 75 years;
- Diagnosed as Multiple Myeloma (MM) according to the international standard for multiple myeloma (IMWG);
- The presence of measurable disease at screening meets one of the following criteria:Serum M-protein ≥ 1.0 g/dL or Urine M-protein ≥ 200 mg/24h or diagnosed as Light-chain MM without measurable disease in serum and urine; Serum free light chain ≥ 10 mg/dL with an abnormal κ/λ ratio;
- Patients must relapse or be refractory after three or more lines of therapy, which at least include: one Proteasome Inhibitor (PI), one Immunomodulatory Drug (IMiD), and one anti-CD38 monoclonal antibody;
- diagnosed as relapsed/refractory disease or primary refractory disease;
- The last treatment is ineffective, or the disease progresses within 60 days after the end of the last therapy;
- Patients must recover from the toxicity of the last therapy (\< grade 2 by CTCAE criteria);
- ECOG score 1-2 points and the expected survival period ≥ 3 months;
- Liver, kidney and cardiopulmonary functions meet the following requirements:
- Total bilirubin ≤ 1.5×ULN, alanine aminotransferase (ALT) ≤ 3 × ULN and aspartate aminotransferase (AST) ≤ 3 × ULN;
- Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 60 mL/min;
- Hemoglobin (Hb) ≥ 50 g/L without prior blood transfusion within 7 days;
- Baseline peripheral oxygen saturation \> 92%;
- Corrected serum calcium ≤ 12.5 mg/dL (≤ 3.1 mmol/L) or free (ionized, ionic) calcium ≤ 6.5 mg/dL (≤ 1.6 mmol/L);
- Left ventricular ejection fraction (LVEF) \> 45%, without confirmed pericardiac effusion and abnormal electrocardiography with clinical significance;
- Without clinically significant pleural effusion;
- Venous access could be established; without contraindications of apheresis.
Exclusion
- Previous diagnosis and treatment of other malignancies within 3 years;
- Patients received previous anti-tumor therapies before apheresis including following therapies: targeted therapies, epigenetics modulation drugs, other drugs or medical devices (invasive) of clinical trials, monoclonal antibodies, cytotoxic agents, PIs, IMiDs, radiotherapy;
- Central Nervous System (CNS) involvement;
- Patients with Fahrenheit macroglobulinemia, POEMS syndrome, or primary AL, amyloidosis;
- Subjects with positive HBsAg or HBcAb positive and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive; HIV antibody positive; CMV DNA titer is higher than the lower limit of detection of the research institution; EBV DNA titer is higher than the lower limit of detection of the research institution;
- Patients have a severe allergic history;
- Patiens have severe systemic diseases or poor cardiovascular, liver, kidney functions;
- Acute or chronic graft versus host disease (GvHD) occurs within 6 months before the screening or needs be treated with immunosuppressive agents;
- Active autoimmune or inflammatory diseases of the nervous system;
- Patients develop oncology emergencies and need to be treated before screening or infusion;
- Uncontrolled infections that need antibiotics treatment;
- Exposure to hematopoietic growth factor of cells within 1-2 weeks before apheresis;
- Exposure to Corticosteriods or immunosuppressive agents within 2 weeks before apheresis;
- Patients receive a major surgical operation within 4 weeks before lymphodepletion or do not recover completely before the enrollment; or plan to receive a major surgical operation during the study period;
- Live attenuated vaccine within 4 weeks before screening;
- Patients with severe mental illness;
- Patients are addcited to alcohol or drugs;
- Pregnant or Lactating Women; Patients and his or her spouse have a fertility plan within two years after CAR-T cell infusion;
- Other conditions considered inappropriate by the researcher.
Key Trial Info
Start Date :
July 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 27 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05998928
Start Date
July 27 2023
End Date
July 27 2026
Last Update
November 13 2023
Active Locations (1)
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1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022