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

September 23, 2024 updated by: Bing, Xu, The First Affiliated Hospital of Xiamen University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Xiamen, Fujian, China, 361000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAR-T
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete remission rate (CR)
Time Frame: Up to 36 months
Negative serum and urine immunofixation electrophoresis, disappearance of soft tissue plasmacytoma, and less than 5% plasma cells in the bone marrow. For patients who rely solely on serum FLC levels as a measurable lesion, in addition to meeting the above CR criteria, it is also required that the ratio of serum FLC is restored to normal in two consecutive evaluations.
Up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events (AE)
Time Frame: Up to 36 months
Any adverse and unexpected signs, symptoms, or diseases.
Up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Xiamen University

Investigators

  • Principal Investigator: Bing Xu, The First Aiffiliated hosptical of xiamen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

August 30, 2024

First Submitted That Met QC Criteria

August 30, 2024

First Posted (Actual)

September 3, 2024

Study Record Updates

Last Update Posted (Actual)

September 25, 2024

Last Update Submitted That Met QC Criteria

September 23, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XMDYYYXYK-11

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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