CAR-T Cell Therapy Tested for Relapsed or Refractory Multiple Myeloma
Tests anti-BCMA CAR-T cell therapy in adults with relapsed or refractory multiple myeloma.
Plain-language title generated from the registry record
Registry title: Anti BCMA CAR- T Cell Therapy for Adults With Relapsed or Refractory Multiple Myeloma
Key facts
- Where
- Minsk, BelarusSee the site
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults whose multiple myeloma came back or did not respond to treatment, and who have already had two earlier lines of treatment.
- Age
- 18 years or older
- Sex
- Women and men can join.
- Disease stage
- Multiple myeloma that came back or did not respond to treatment (IMWG criteria), after two previous lines of therapy and resistance to proteasome inhibitors and immunomodulators. ECOG performance status 0 to 2.
- Earlier treatment
- Must have had two previous lines of therapy. Must not have had earlier anti BCMA therapy.
Main reasons for not taking part
- Pregnant or breastfeeding women
- Active cancer in the brain or spinal cord, or serious brain or nerve conditions
- Active infection needing treatment, or hepatitis B, hepatitis C, HIV, HTLV or syphilis
- Serious uncontrolled heart disease or a heart event in the last 12 months
- Prior anti BCMA therapy
Read by machine on 9 November 2026.
Where in Belarus
- State Institution Minsk Scientific and Practical Center for Surgery, Transplantology, and HematologyMinsk, BelarusTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
- Trial code
- NCT07477912
- Record updated
- 16 October 2026
- Original description
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 myelomaRead full original descriptionShow less
Phase I/II Open-label Study Evaluating The Safety And Efficacy of Anti BCMA CAR-T Cell Therapy in Adults With R/ R Multiple Myeloma
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
Inclusion: Male or female, aged ≥18 years; Willing and able to give written, informed consent; Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2; Relapsed or refractory multiple myeloma according to IMWG criteria with two previous lines of therapy and resistance to proteosome inhibitors and immunomodulators; Adequate organ system function including; Creatinine clearance ≥30 cc/min; Serum alanine aminotransferase / aspartate aminotransferase ≤2.5 x upper limit of normal (ULN); Total bilirubin ≤1.5 x ULN, except in subjects with Gilbert's syndrome; Left ventricular ejection fraction (LVEF) ≥50% (by echocardiogram [ECHO] or; Baseline oxygen saturation >92% on room air and ≤Grade 1 dyspnoea; Have no active GVHD (Grade 2-4); Adequate bone marrow (BM) function; Absolute neutrophil count ≥1.0 × 10\^9/L; Absolute lymphocyte count ≥0.3 × 10\^9/L (at enrolment and prior to leukapheresis); Haemoglobin ≥80 g/L; Platelets ≥50 × 10\^9/L.
Exclusion: History or presence of clinically relevant CNS pathology such as epilepsy, paresis, aphasia, stroke within prior 3 months, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, or psychosis; Patients with active CNS involvement by malignancy. Patients with history of central nervous system (CNS) involvement with malignancy may be eligible if CNS disease has been effectively treated and provided treatment was at least 4 weeks prior to enrolment (at least 8 weeks prior to CAR-T infusion); The following medications are excluded:; Steroids: Therapeutic doses of corticosteroids within 7 days of leukapheresis or 72 hours prior to CAR-T administration. However, physiological replacement, topical, and inhaled steroids are permitted; Immunosuppression: Immunosuppressive medication must be stopped ≥2 weeks prior to leukapheresis or CAR-T cells infusion; Cytotoxic chemotherapies within 1 week of CAR-T cellsinfusion and 1 week prior to leukapheresis; Granulocyte-colony stimulating factor less than 14 days prior to leukapheresis; Live vaccine ≤4 weeks prior to enrolment; Clinically significant, uncontrolled heart disease or a recent (within 12 months) cardiac event; Active bacterial, viral or fungal infection requiring systemic treatment. Active or latent hepatitis B infection or hepatitis C infection. Testing positive for human immunodeficiency virus, human T cell lymphotropic virus (HTLV1 and 2) or syphilis; History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 24 months; Evidence of active pneumonitis on chest computed tomography (CT) scan at screening or history of drug-induced pneumonitis, idiopathic pulmonary fibrosis, organising pneumonia, or idiopathic pneumonitis; History of other malignant neoplasms unless disease free for at least 24 months (carcinoma in situ, non-melanoma skin cancer, breast or prostate cancer on hormonal therapy allowed); Any other condition that in the Investigator's opinion would make the patient unsuitable for the clinical trial; Prophylactic intrathecal therapy: Methotrexate within 4 weeks and other intrathecal chemotherapy (e.g. Ara-C) within 2 weeks prior to starting pre-conditioning chemotherapy; Prior limited radiation therapy within 2 weeks of CAR-T cells infusion. 9. Prior anti BCMA therapy 10. Known allergy to albumin, dimethyl sulphoxide (DMSO), cyclophosphamide or fludarabine or tocilizumab; Females who are pregnant or lactating.