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

Official title

A Clinical Study of the Safety and Efficacy of Chimeric Antigen Receptor-modified T Cells Targeting BCMA for the Treatment of Relapsed/Refractory Multiple Myeloma

Overview

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.

Interventions

• Biological 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.

Primary outcome measures

• Complete remission rate (CR) [Time frame: Up to 36 months]

Secondary outcome measures (1)

• Adverse events (AE) [Time frame: Up to 36 months]

Eligibility criteria

Inclusion criteria

• Age 18-80 years, no gender restrictions;
• Diagnosed with refractory/relapsed multiple myeloma through physical examination, pathological examination, laboratory tests, and imaging studies;
• Flow cytometry or histology confirms positive BCMA expression in myeloma cells;
• As judged by the investigator, the expected survival time is >3 months;
• ECOG performance status score ≤2, KPS >60%;
• 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%;
• 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;
• Those with fertility must agree to use highly effective contraceptive methods;
• The subject or their legal guardian can understand and is willing to sign a written informed consent form voluntarily.

Exclusion criteria

• Pregnant or nursing women, as well as women planning to become pregnant within the next six months;
• Positive virology tests for hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus;
• 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);
• Previously received treatment targeting BCMA;
• Underwent autologous hematopoietic stem cell transplantation within the last 6 weeks;
• Presence of uncontrolled active bacterial or fungal infection;
• Allergic to research-related drugs or cell components;
• Presence of active autoimmune diseases;
• Currently have unstable or active ulcers or gastrointestinal bleeding;
• Unable to cooperate with treatment and efficacy evaluation due to mental or psychological disorders;
• Received other experimental drug treatments within the last 3 months;
• The researcher believes that for other reasons, the individual is not suitable for the clinical trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The First Affiliated Hospital of Xiamen University — Xiamen

Identifiers

NCT: NCT06581640 · XMDYYYXYK-11

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗