A Study of BCMA-directed CAR-T Cells Treatment in Subjects With r/r Multiple Myeloma

NCT ID: NCT04322292

Last Updated: 2026-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-12
• Study Completion Date: 2022-09-22

Brief Summary

This is a single-center, non-randomized and dose-escalation study to evaluate the safety and efficacy of C-CAR088 in relapsed or refractory multiple myeloma patient.

Detailed Description

The study will include the following sequential phases: Screening, Pre- Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), C-CAR088 infusion and Follow-up.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

C-CAR088

Lymphocytes will be transduced with lentiviral vector containing CAR-BCMA gene.

Group Type: EXPERIMENTAL

C-CAR088

Intervention Type: DRUG

Autologous BCMA-directed CAR-T cells, single infusion intravenously at a target dose of 1.0-9.0 x 10^6 anti-BCMA CAR+T cells/kg.

Other Name: CBM.BCMA Chimeric Antigen Receptor T cell.

Interventions

C-CAR088

Autologous BCMA-directed CAR-T cells, single infusion intravenously at a target dose of 1.0-9.0 x 10^6 anti-BCMA CAR+T cells/kg.

Other Name: CBM.BCMA Chimeric Antigen Receptor T cell.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age 18-75 years old, male or female;

2. The patient volunteered to participate in the study, and he or his legal guardian signed the Informed Consent;

3. Meet the internationally accepted Criteria for the diagnosis of multiple myeloma (IMWG diagnostic criteria 2014);

4. Patients with a clear diagnosis of relapsed or refractory multiple myeloma；

5. The patient have one or more measurable multiple myeloma lesion, must include one of the following conditions:

• Serum M protein≥1.0 g/dL(10g/L)
• Urine M protein≥200 mg/24h
• Serum free light chain(sFLC): κ/λ FLC ratio is abnormal and affected FLC ≥10mg / dL

6. Bone marrow sample is confirmed as BCMA-positive by flow cytometry or pathological examination;

7. ECOG scores 0 - 1;

8. Echocardiography showed normal diastolic function, left ventricular ejection fraction (LVEF) ≥50%, and no severe arrhythmia;

9. No active pulmonary infections, normal pulmonary function and oxygen saturation ≥ 92% on room air.

10. Absolute neutrophil count ≥1.0 × 109 / L, platelet count ≥50 × 109 / L; total serum bilirubin ≤1.5mg / dl; serum ALT or AST less than 2.5 times the upper limit of normal; serum creatinine ≤2.0mg / dl;

11. No contraindications of peripheral blood apheresis;

12. Expected survival time > 12 weeks;.

13. Female subjects of childbearing age must have a negative urine / blood pregnancy test within 7 days before cell therapy and not be in lactation; female or male subjects of childbearing age need to take effective contraception throughout the study.

Exclusion Criteria

1. Have a history of allergy to cellular products;

2. Presence of clinically significant cardiovascular disease;

3. A history of craniocerebral trauma, consciousness disorder, epilepsy, severe cerebral ischemia or hemorrhagic disease;

4. Need to use any anticoagulant (except aspirin);

5. Patients requiring urgent treatment due to tumor progression or spinal cord compression;

6. Patients with CNS metastasis or symptoms of CNS involvement;

7. After allogeneic hematopoietic stem cell transplantation;

8. Plasma cell leukemia;

9. Received systemic anti-tumor treatment within 2 weeks before apheresis, and within 1 week before apheresis, prednisone (or equivalent amount of other corticosteroids) was applied in excess of 5 mg/d ;

10. Patients with autoimmune diseases, immunodeficiency, or other immunosuppressive agents;

11. Uncontrolled active infection;

12. Have used any CAR T cell products or other genetically modified T cell therapy before;

13. Hepatitis B or hepatitis C virus infection (including carriers), syphilis, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV infected persons;

14. Have a history of alcoholism, drug addiction and mental illness;

15. Participated in any other clinical trial within 1 months;

16. The investigators believe that there are other circumstances that are not suitable for the trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

InstituteHBDH

Tianjin, , China

Countries

China

References

Qu X, An G, Sui W, Wang T, Zhang X, Yang J, Zhang Y, Zhang L, Zhu D, Huang J, Zhu S, Yao X, Li J, Zheng C, Zhu K, Wei Y, Lv X, Lan L, Yao Y, Zhou D, Lu P, Qiu L, Li J. Phase 1 study of C-CAR088, a novel humanized anti-BCMA CAR T-cell therapy in relapsed/refractory multiple myeloma. J Immunother Cancer. 2022 Sep;10(9):e005145. doi: 10.1136/jitc-2022-005145.

Reference Type: DERIVED

PMID: 36100310 (View on PubMed)

Other Identifiers

QT2019007

Identifier Type: -

Identifier Source: org_study_id