What is anti-BCMA CAR-T cell therapy studying for relapsed or refractory multiple myeloma?

Anti-BCMA CAR-T cell therapy is being studied as a treatment option for adults with relapsed or refractory multiple myeloma. The research aims to evaluate its safety and how well it works in patients who have not responded to other treatments. The trial is sponsored by the Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology.

Who may be eligible for this multiple myeloma clinical trial?

Adults aged 18 years or older with relapsed or refractory multiple myeloma who have received at least two prior therapies may be eligible. Participants must have adequate organ function and no active severe infections or certain neurological conditions. Both men and women can join. Please review eligibility criteria for more details.

Is there any cost to participate in this multiple myeloma clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation costs.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years +

All Genders

ID07477912

Phase III Study of 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

Participants Needed

Research Sites

104 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying anti-BCMA CAR-T cell immunotherapy in adults with relapsed or refractory multiple myeloma. This Phase III open-label trial aims to evaluate the safety, tolerability, and effectiveness of this treatment in patients who have received at least two prior therapies and have resistant disease. The study will explore important safety concerns such as cytokine release syndrome, neurological side effects, infections, and blood cell changes, as well as treatment response and survival outcomes. The treatment process involves collecting the patients own T cells through leukapheresis, followed by chemotherapy preconditioning with fludarabine and cyclophosphamide. After this conditioning, a single infusion of the anti-BCMA CAR-T cells is given. Dosages range from 50 million to 250 million CAR-T cells. The study is divided into Phase I focusing on safety and pharmacokinetics and Phase II concentrating on overall response rates and long-term outcomes. Participants will be monitored closely with safety assessments for one month after infusion and followed up for treatment response and survival for up to three years. Researchers will measure how well the CAR-T cells expand and persist in the body, track progression-free and overall survival rates, and observe the duration of response. Trial visits will include clinical evaluations and laboratory tests to assess organ function and disease status throughout the study period.

CONDITIONS

Brief Title

Anti BCMA CAR- T Cell Therapy for Adults With Relapsed or Refractory Multiple Myeloma

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Male or female aged 18 years or older
Willing and able to give written informed consent
ECOG Performance Status between 0 and 2
Diagnosed with relapsed or refractory multiple myeloma after at least two prior therapies, resistant to proteasome inhibitors and immunomodulators
Adequate organ function including creatinine clearance of at least 30 cc/min, liver enzymes no more than 2.5 times the upper limit, total bilirubin no more than 1.5 times the upper limit (except Gilbert's syndrome), and left ventricular ejection fraction of 50% or higher
Baseline oxygen saturation above 92% on room air with mild or no shortness of breath
No active graft-versus-host disease grade 2 or higher
Adequate bone marrow function with neutrophil count at least 1.0 x 10^9/L, lymphocyte count 0.3 x 10^9/L or higher, hemoglobin at least 80 g/L, and platelets at least 50 x 10^9/L

You will not qualify if you...

Pregnant or lactating females
History or presence of significant central nervous system disorders such as epilepsy, recent stroke, severe brain injury, Parkinson's disease, dementia, or uncontrolled mental illness
Active central nervous system cancer involvement unless effectively treated at least 4 weeks prior to enrollment
Uncontrolled or recent serious heart disease within the past 12 months
Active infections requiring treatment or positive tests for hepatitis B or C, HIV, HTLV1/2, or syphilis
Autoimmune diseases causing organ damage or requiring systemic immunosuppression within the last 24 months
Active lung inflammation or prior drug-induced lung disease
History of other cancers unless disease-free for at least 24 months, with some exceptions
Recent use of certain medications including therapeutic corticosteroids, immunosuppressants, cytotoxic chemotherapy, granulocyte-colony stimulating factor, live vaccines, or intrathecal chemotherapy within specified timeframes
Prior anti-BCMA therapy
Known allergies to albumin, DMSO, cyclophosphamide, fludarabine, or tocilizumab
Any condition deemed unsuitable by the investigator for trial participation

Research Team

Mikhail Uss, MD

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Phase III Study of Anti-BCMA CAR-T Cell Therapy for Adults with Relapsed or Refractory Multiple Myeloma

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria