Chimeric Antigen Receptor Modified T Cells Targeting BCMA for the Treatment of Relapsed/Refractory Multiple Myeloma

NCT ID: NCT06581640

Last Updated: 2024-09-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-24
• Study Completion Date: 2028-12-31

Brief Summary

To evaluate the safety and tolerability of chimeric antigen receptor gene-modified T cells targeting BCMA for the treatment of relapsed/refractory multiple myeloma

Detailed Description

Subjects who meet the eligibility criteria, PBMC will be collected by blood cell separator and 50 mL of plasma will be collected for preparation of CAR-T and frozen storage of CAR-T preparations; patients will be treated with autologous BCMA CAR-T transfusion and followed up for a period of 3 years, with specific efficacy judgments referring to the IMWG Clinical Efficacy Evaluation Criteria.

Conditions

Multiple Myeloma; Relapsed/Refractory

Study Design

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

Study Groups

CAR-T

Group Type: EXPERIMENTAL

CAR-T treatment

Intervention Type: BIOLOGICAL

Peripheral blood lymphocyte collection, PBMC separation, BCMA CAR-T cell preparation/storage, lymphodepletion chemotherapy pretreatment for the subject, and BCMA CAR-T cell infusion.

Interventions

CAR-T treatment

Peripheral blood lymphocyte collection, PBMC separation, BCMA CAR-T cell preparation/storage, lymphodepletion chemotherapy pretreatment for the subject, and BCMA CAR-T cell infusion.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Age 18-80 years, no gender restrictions;

2. Diagnosed with refractory/relapsed multiple myeloma through physical examination, pathological examination, laboratory tests, and imaging studies;

3. Flow cytometry or histology confirms positive BCMA expression in myeloma cells;

4. As judged by the investigator, the expected survival time is >3 months;

5. ECOG performance status score ≤2, KPS >60%;

6. The patient has good liver, kidney, heart, and lung function: ALT and AST ≤2.5×ULN, those with liver involvement can be relaxed to ≤5×ULN; serum total bilirubin <34 μmol/L; creatinine clearance rate >30 mL/min; heart ejection fraction (EF) ≥40%, no pericardial effusion and significant arrhythmia; indoor SpO2 ≥92%;

7. Peripheral blood lymphocyte absolute count ALC ≥0.5 ×10^9/L, PLT >30×10^9/L, Hb >80 g/L and has a single collection venous access, and there are no other contraindications for hematopoietic cell separation;

8. Those with fertility must agree to use highly effective contraceptive methods;

9. The subject or their legal guardian can understand and is willing to sign a written informed consent form voluntarily.

Exclusion Criteria

1. Pregnant or nursing women, as well as women planning to become pregnant within the next six months;

2. Positive virology tests for hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus;

3. History of other tumors (except for those with skin or cervical in situ cancers that have been cured by radical treatment and show no evidence of disease activity);

4. Previously received treatment targeting BCMA;

5. Underwent autologous hematopoietic stem cell transplantation within the last 6 weeks;

6. Presence of uncontrolled active bacterial or fungal infection;

7. Allergic to research-related drugs or cell components;

8. Presence of active autoimmune diseases;

9. Currently have unstable or active ulcers or gastrointestinal bleeding;

10. Unable to cooperate with treatment and efficacy evaluation due to mental or psychological disorders;

11. Received other experimental drug treatments within the last 3 months;

12. The researcher believes that for other reasons, the individual is not suitable for the clinical trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Xiamen University

OTHER

Sponsor Role: lead

Responsible Party

Bing, Xu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bing Xu

Role: PRINCIPAL_INVESTIGATOR

The First Aiffiliated hosptical of xiamen University

Locations

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Bing Xu

Role: CONTACT

xubingzhangjian@126.com

18750918842

Facility Contacts

Bing Xu

Role: primary

xubingzhangjian@126.com

Other Identifiers

XMDYYYXYK-11

Identifier Type: -

Identifier Source: org_study_id