Status:
RECRUITING
Safety and Efficacy of Anti-BCMA-GPRC5D CAR-T Cells Therapy in the Treatment of r/r MM
Lead Sponsor:
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Collaborating Sponsors:
Guangzhou Bio-gene Technology Co., Ltd
Conditions:
Relapsed/Refractory Multiple Myeloma
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of bispecific BCMA-GPRC5D CAR-T cells in patients with relapsed or refractory multiple myeloma who received th...
Detailed Description
This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of bispecific BCMA-GPRC5D CAR-T cells in patients with relapsed or refractory multiple myeloma who received th...
Eligibility Criteria
Inclusion
- The patient or his/her guardian understands and voluntarily signs the informed consent, and is expected to complete the follow-up examination and treatment of the study procedure;
- Age 18-75 years old, gender unlimited;
- 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;
- The patient has recovered from the toxicity of the prior treatment, i.e., CTCAE toxicity grade \< 2 (unless the abnormality is related to the tumor or is stable as judged by the investigator and has little impact on safety or efficacy);
- 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
- Have been diagnosed with or treated for aggressive malignancies other than multiple myeloma;
- Prior antitumor therapy (prior to blood collection for CAR-T preparation) : targeted therapy, epigenetic therapy, or investigational drug therapy within 14 days or at least 5 half-lives, whichever is shorter;
- It is suspected that MM has involved the central nervous system or meninges and has been confirmed by MRI or CT, or there are other active central nervous system diseases;
- 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;
- Any unstable systemic disease: including but not limited to unstable angina, cerebrovascular accident or transient cerebral ischemia (within 6 months before screening), myocardial infarction (within 6 months before screening), congestive heart failure \[New York Heart Association (NYHA) classification ≥ grade III\];
- Systemic diseases judged by researchers to be unstable: including but not limited to severe liver, kidney or metabolic diseases requiring drug treatment;
- Patients with acute/chronic graft-versus-host disease (GVHD) or requiring immunosuppressive therapy for GVHD within 6 months prior to screening;
- 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;
- Persons with serious mental illness;
- Alcoholics or persons with a history of drug abuse;
- Pregnant or Lactating Women; Patients and his or her spouse have a fertility plan within two years after CAR-T cell infusion;
- Any unsuitable to participate in this trial judged by the investigator.
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06515262
Start Date
July 1 2024
End Date
December 1 2026
Last Update
July 23 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sanbin Wang
Kunming, Kunming, Yunnan, China, 650100