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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

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

Anti BCMA CAR- T Cell Therapy for Adults With Relapsed or Refractory Multiple Myeloma (NCT07477912) is a Phase 1 / Phase 2 interventional studying Multiple Myeloma Refractory, sponsored by Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Multiple Myeloma Refractory, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 30 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Male or female, aged ≥18 years. 2. Willing and able to give written, willing to sign a consent form. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2. 4. Relapsed or refractory multiple myeloma according to IMWG criteria with two previous lines of therapy and resistance to proteosome inhibitors and immunomodulators. 5. Adequate organ system function including \- kidney function (creatinine clearance) at least 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. 6. Have no active GVHD (Grade 2-4) 7. 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. - platelet count at least 50 × 10\^9/L Who Should NOT Join This Trial: 1. Females who are pregnant or lactating. 2. 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. 3. 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). 4. Clinically significant, uncontrolled heart disease or a recent (within 12 months) cardiac event. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Male or female, aged ≥18 years. 2. Willing and able to give written, informed consent. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2. 4. Relapsed or refractory multiple myeloma according to IMWG criteria with two previous lines of therapy and resistance to proteosome inhibitors and immunomodulators. 5. 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. 6. Have no active GVHD (Grade 2-4) 7. 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 Criteria: 1. Females who are pregnant or lactating. 2. 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. 3. 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). 4. Clinically significant, uncontrolled heart disease or a recent (within 12 months) cardiac event. 5. 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. 6. History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 24 months. 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.

Treatments Being Tested

BIOLOGICAL

anti BCMA CAR-T cells

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

State Institution Minsk Scientific and Practical Center for Surgery, Transplantology, and Hematology
Minsk, Belarus

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07477912), the sponsor (Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07477912 clinical trial studying?

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 The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07477912?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07477912?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07477912. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07477912. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.