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

NCT07477912 | Recruiting Phase 1 DMC

• 1 other identifier: 123.23
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Multiple Myeloma Refractory

Keywords

CAR-T therapy; multiple myeloma

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  12 months post CAR-T cells infusion

Secondary Outcomes (5)

• Phase I. duration of expansion of CAR-T cells

  12 months post CAR-T cells infusion

• Phase II. Efficacy: Overall survival rates

  3 years post CAR-T cells infusion

• Phase II. Progression-free survival rates

  3 years post CAR-T cells infusion

• Phase II. Duration of response

  3 years post CAR-T cells infusion

• Phase I. Peak of expansion of CAR-T cells

  1 month post CAR-T cells infusion

Study Arms (1)

anti BCMA CAR-T cell-immunotherapy

EXPERIMENTAL

Biological: anti BCMA CAR-T cells

Interventions

anti BCMA CAR-T cells BIOLOGICAL

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

anti BCMA CAR-T cell-immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• \. 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).
• \. 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.

Sponsors & Collaborators

• Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology: lead

Study Sites (1)

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

Minsk, 220087, Belarus

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Mikhail Uss, MD

  State Institution Minsk Scientific and Practical Center for Surgery, Transplantology, and Hematology, Minsk, 220087

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mikhail Uss, MD

CONTACT

+375291362230; mikhail.uss@mail.ru

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Mikhail Uss. Head of the Department of Bone Marrow Transplantation, Researcher

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 17, 2026
• Study Start: February 1, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2030
• Last Updated: March 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

BE (1)