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

NCT ID: NCT04295018

Last Updated: 2020-03-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-23
• Study Completion Date: 2021-12-31

Brief Summary

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

Detailed Description

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

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

4. 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

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

6. At least 2 weeks from monoclonal antibody therapy prior to CAR T cell therapy.

7. ECOG scores 0 - 1;

8. Good cardiac and pulmonary organ function;

9. Expected survival time > 12 weeks;.

10. 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. Laboratory testing occurs when: including but not limited to, serum total bilirubin ≥1.5mg / dl; serum ALT or AST is 2.5 times higher than the upper limit of normal value; serum creatinine ≥2.0mg / dl; hemoglobin <80g / L; absolute neutrophil count <1000 / mm3 or dependent on GCSF or Other growth factors can maintain the centriole count ≥1000 / mm²; platelet count <50000 / mm³ or the above level can be maintained due to platelet transfusion;

3. Presence of clinically significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or any heart function Grade 3 (moderate) or Grade 4 (severe) heart disease (according to the New York Heart Association Function Classification method: NYHA); patients with a history of myocardial infarction, cardiac angioplasty or stent implantation, unstable angina pectoris or other clinically significant heart disease within 12 months before enrollment;

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

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

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

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

8. After allogeneic hematopoietic stem cell transplantation;

9. Plasma cell leukemia;

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

Shanghai AbelZeta Ltd.

INDUSTRY

Sponsor Role: collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daobin Zhou

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Daobin Zhou, PhD&MD

Role: CONTACT

zhoudb@pumch.cn

010-69155020

Lu Zhang

Role: CONTACT

pumczhanglu@163.com

010-69155660

Facility Contacts

Daobin Zhou, PhD&MD

Role: primary

zhoudb@pumch.cn

010-69155020

Lu Zhang

Role: backup

pumczhanglu@163.com

010-69155660

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

0203-007

Identifier Type: -

Identifier Source: org_study_id