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Trial Title:
Chimeric Antigen Receptor Modified T Cells Targeting BCMA for the Treatment of Relapsed/Refractory Multiple Myeloma
NCT ID:
NCT06581640
Condition:
Multiple Myeloma
Relapsed/Refractory
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
CAR-T treatment
Description:
Peripheral blood lymphocyte collection, PBMC separation, BCMA CAR-T cell
preparation/storage, lymphodepletion chemotherapy pretreatment for the subject, and BCMA
CAR-T cell infusion.
Arm group label:
CAR-T
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Xiamen University
Address:
City:
Xiamen
Zip:
361000
Country:
China
Status:
Recruiting
Contact:
Last name:
Bing Xu
Email:
xubingzhangjian@126.com
Start date:
September 24, 2024
Completion date:
December 31, 2028
Lead sponsor:
Agency:
The First Affiliated Hospital of Xiamen University
Agency class:
Other
Source:
The First Affiliated Hospital of Xiamen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06581640
