Clinical Study on the Safety and Efficacy of BCMA-CART±ASCT in Treating Young Multiple Myeloma Patients

NCT07169500 | Recruiting Phase 1

• 1 other identifier: IIT2025025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate and compare the safety and efficacy of BCMA-CART ± ASCT in the treatment of newly diagnosed multiple myeloma (NDMM) in young patients

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Assessment and comparison of MRD negativity rate 3 months after BCMA-CART±ASCT

  MRD by flow cytometry

  3 month

Secondary Outcomes (7)

• Progression-free Survival (PFS)

  2 years after CAR-T infusion

• Minimal Residual Disease (MRD) negetive rate

  at day28, M2, M3, M6, M9, M12, M15, M18, M24 after CAR-T infusion

• Overall response rate (ORR) evaluated by the investigators

  2 years after CAR-T infusion

• Duration of Response (DOR)

  2 years after CAR-T infusion

• Time to Response (TTR)

  2 years after CAR-T infusion

Study Arms (1)

BCMA-CART

EXPERIMENTAL

All study participants are non-randomly assigned based on their disease status before the start of treatment. Those suitable for transplantation enter the transplantation (ASCT CART) treatment group, while those not suitable for transplantation enter the non-transplant treatment group. Participants in the transplant group will undergo ASCT at an appropriate time before receiving BCMA-CART treatment. Participants in the non-transplant group do not need to undergo ASCT and can proceed directly to BCMA-CART treatment at an appropriate time.

Biological: CAR-T

Interventions

CAR-T BIOLOGICAL

Chimeric antigen receptor T cells (car-t) are genetically engineered MHC independent tumor specific killer cells.

BCMA-CART

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects voluntarily participate in the study and sign the informed consent form (ICF) themselves or through their legal guardian;
• Confirmed diagnosis of multiple myeloma through flow cytometry or immunohistochemistry;
• Subjects must have adequate organ function and meet all of the following test results:
• Serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN)
• Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN
• Creatinine clearance (CrCl) (Cockcroft-Gault formula) ≥ 40 ml/min
• Prothrombin time (PT) ≤ 1.5 × ULN, activated partial thromboplastin time (APTT) \< 1.5 × ULN, international normalized ratio (INR) \< 1.5 × ULN
• Hemoglobin (Hb) ≥ 60 g/L
• Absolute neutrophil count (ANC) ≥ 1.0 × 10\^9/L (no granulocyte colony-stimulating factor \[G-CSF\] or other growth factors received within 7 days prior to screening laboratory tests)
• Absolute lymphocyte count (ALC) ≥ 0.5 × 10\^9/L
• Platelets (PLT) ≥ 50 × 10\^9/L (no platelet transfusion received within 7 days prior to screening laboratory tests)
• Left ventricular ejection fraction (LVEF) ≥ 45%
• Blood oxygen saturation (SpO2) ≥ 92%
• ECOG score of 0-1, see Appendix 5 for ECOG scoring;
• Expected survival ≥ 3 months;

You may not qualify if:

• History of allergy to any component of the cellular product;
• Severe heart disease, including but not limited to:
• Myocardial infarction, coronary angioplasty, or stent implantation within 6 months prior to signing the ICF
• Unstable angina
• Severe arrhythmia
• History of severe non-ischemic cardiomyopathy
• Congestive heart failure (New York Heart Association \[NYHA\] class III or IV), NYHA scores are in Appendix 2
• Stroke or seizure within 6 months prior to signing the ICF;
• Autoimmune diseases, immunodeficiency, or other conditions requiring immunosuppressive therapy;
• Malignant tumors other than multiple myeloma within 3 years prior to signing the ICF, except fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, ductal carcinoma in situ of the breast after radical surgery, and other in situ cancers at other sites one year after radical surgery, provided there is no ongoing treatment and no signs of recurrence during the screening period;
• Presence of uncontrolled active infection;
• Unstable systemic diseases as judged by the investigator, including but not limited to severe liver, kidney, or metabolic diseases requiring medication.
• Within one week before lymphocyte collection, the storage device falls under any of the following conditions:
• Peripheral blood hepatitis B virus (HBV) DNA test value is above the detection limit
• Hepatitis C virus (HCV) antibody positive and peripheral HCV-RNA positive

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead
• Hebei Taihe Chunyu Biotechnology Co., Ltd: collaborator

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

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

• Yan Xu, MD

  Institute of Hematology & Blood Diseases Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Xu, MD

CONTACT

13920593907; xuyan1@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a single-center, open-label, prospective investigator-initiated clinical trial. Patients are assigned to treatment groups non-randomly based on their condition and disease status, and are divided into a transplant group and a non-transplant group depending on whether they undergo ASCT. The study aims to analyze and compare the safety and efficacy of BCMA-CART ± ASCT treatment in young MM patients. Each group plans to enroll 25 subjects, with a total of 50 subjects expected to be enrolled in this study. After treatment, subjects will be followed up for safety and efficacy until the completion of the study or withdrawal from the study (withdrawal reasons include disease progression, loss to follow-up, withdrawal of informed consent, adverse events, initiation of new anti-tumor treatment, death, etc.), with the first occurrence taking precedence.

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: September 11, 2025
• Study Start: March 3, 2025
• Primary Completion (Estimated): March 2, 2028
• Study Completion (Estimated): March 2, 2030
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)