Multiple Myeloma RefractoryPhase 1/2MSTH-CAR001NCT07477912
Anti BCMA CAR- T Cell Therapy for Adults With Relapsed or Refractory Multiple Myeloma
A Phase 1/2 study testing anti BCMA CAR-T cells in people with Multiple Myeloma Refractory, run by Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology at 1 site in Belarus.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma Refractory
- What is being tested?
- anti BCMA CAR-T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelarus
- Study dates
- 1 Feb 2025to 1 Feb 2030
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- Females who are pregnant or lactating.
- 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).
- 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.
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- 6. 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.
- 7. 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).
- 8. 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.
- 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.
- 11. Any other condition that in the Investigator's opinion would make the patient unsuitable for the clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belarus1 site, 1 recruiting
- Recruiting
State Institution Minsk Scientific and Practical Center for Surgery, Transplantology, and Hematology
Minsk, 220087
Mikhail Uss, MD, +375291362230, mikhail.uss@mail.ru
About this study
Official title: 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
Read the detailed description
Locally manufactured second generation autologous humanized anti-BCMA cells are used for immunotherapy. Protocol treatment includes leukapheresis in order to harvest T cells, lymphodepleting conditioning (fludarabine 30 mg/m2+ cyclophosphamide 300 mg/2(days -5-3)) followed by one anti (day 0) BCMA CAR-T cell infusion.
The Main research objectives of the Phase I:
To preliminarily explore the safety (incidence of CRS, ICANS, HLH, infections, late ICAHT, p arkinsonism and cytopenias) and tolerability.
The Secondary research objectives of the Phase I:
To explore the pharmacokinetics of CAR-T cells.
The Main research objectives of the Phase II:
Overall response rate, including partial response (PR), very good partial response (VGPR), complete response (CR) and stringent complete response(sCR) rates.
The Secondary research objectives of the Phase II:
Duration of response (DOR). Progression-free survival rates. Overall survival rates.
- Conditions
- Multiple Myeloma Refractory
- Being tested
- anti BCMA CAR-T cells
- Keywords
- CAR-T therapy, multiple myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti BCMA CAR-T cellsBiological
Following preconditioning with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with doses from 50 x 10⁶ to 250 x 10⁶ anti BCMA CAR-T cells
| Study group | Role | What they receive |
|---|---|---|
| anti BCMA CAR-T cell-immunotherapy | Experimental | Not described Receives: Biological: anti BCMA CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I. Safety
Number of Participants With Grade 3-5 Toxicities. Adverse events will be graded according to the CTCAE v5.0, ICAHT and ASCTC.
Measured: 1 month post CAR-T cells infusion
Phase II. Overall response rate
partial response (PR), very good partial response (VGPR), complete response (CR) and stringent complete response (sCR) rates according to IMVG criteria
Measured: 12 months post CAR-T cells infusion
Secondary outcomes (5)
Phase I. duration of expansion of CAR-T cells
To explore the pharmacokinetics of CAR-T cells:
- duration of expansion of CAR-T cells by flow cytometry - duration of cell detection in peripheral blood (days)
Measured: 12 months post CAR-T cells infusion
Phase II. Efficacy: Overall survival rates
Overall survival rates
Measured: 3 years post CAR-T cells infusion
Phase II. Progression-free survival rates
progression-free survival time
Measured: 3 years post CAR-T cells infusion
Phase II. Duration of response
duration of response
Measured: 3 years post CAR-T cells infusion
Phase I. Peak of expansion of CAR-T cells
- peak of expansion of CAR-T cells (cells/µl) - The day of maximum cell concentration in peripheral blood and bone marrow (day)
Measured: 1 month post CAR-T cells infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 Feb 2025
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma RefractoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mikhail Uss, Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
- Investigators
- Mikhail Uss, MD, Principal investigator, State Institution Minsk Scientific and Practical Center for Surgery, Transplantology, and Hematology, Minsk, 220087
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07477912
- Sponsor's protocol ID
- 123.23
- Acronym
- MSTH-CAR001
- Status last verified
- Feb 2026
- First submitted
- 24 Feb 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes