Actively Recruiting
Anti BCMA CAR- T Cell Therapy for Adults With Relapsed or Refractory Multiple Myeloma
Led by Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology · Updated on 2026-03-17
30
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The mail purpose of this study is to estimate the safety and the efficacy of anti-BCMA CAR- T cell immunotherapy for adults with relapsed or refractory multiple myeloma
CONDITIONS
Official Title
Anti BCMA CAR- T Cell Therapy for Adults With Relapsed or Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, aged 218 years or older.
- Willing and able to give written, informed consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
- Diagnosed with relapsed or refractory multiple myeloma according to IMWG criteria after two prior lines of therapy.
- Resistant to proteasome inhibitors and immunomodulators.
- Adequate organ function including creatinine clearance 230 cc/min, liver enzymes 2.5 times upper limit of normal, total bilirubin 1.5 times upper limit of normal (except Gilbert's syndrome), and left ventricular ejection fraction 250%.
- Baseline oxygen saturation greater than 92% on room air with dyspnea 2 grade 1 or less.
- No active graft-versus-host disease (Grade 2-4).
- Adequate bone marrow function with specified neutrophil, lymphocyte, hemoglobin, and platelet counts before leukapheresis.
You will not qualify if you...
- Females who are pregnant or breastfeeding.
- History or presence of significant central nervous system disorders such as epilepsy, stroke within 3 months, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, or psychosis.
- Active central nervous system involvement by cancer unless effectively treated at least 4 weeks prior to enrollment.
- Clinically significant uncontrolled heart disease or recent cardiac events within 12 months.
- Active bacterial, viral, or fungal infections needing treatment; positive tests for HIV, HTLV1 or 2, or syphilis.
- History of autoimmune disease causing organ injury or requiring immunosuppression within 24 months.
- Evidence of active pneumonitis or history of drug-induced pneumonitis or similar lung diseases.
- History of other cancers unless disease-free for at least 24 months (except certain skin, breast, or prostate cancers on hormonal therapy).
- Use of certain medications including recent steroids, immunosuppressants, cytotoxic chemotherapy, granulocyte-colony stimulating factor, live vaccines, and recent intrathecal chemotherapy.
- Prior limited radiation therapy within 2 weeks of CAR-T infusion.
- Previous anti-BCMA therapy.
- Known allergies to albumin, dimethyl sulphoxide (DMSO), cyclophosphamide, fludarabine, or tocilizumab.
- Any other condition that the investigator believes would make participation unsuitable.
AI-Screening
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Trial Site Locations
Total: 1 location
1
State Institution Minsk Scientific and Practical Center for Surgery, Transplantology, and Hematology
Minsk, Belarus, 220087
Actively Recruiting
Research Team
M
Mikhail Uss, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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