CAR19-BCMA Dual-target CAR-T in the Treatment of Relapsed / Refractory Multiple Myeloma

NCT07249073 | Recruiting Early Phase 1

• 1 other identifier: IIT2025040
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Objective to evaluate the safety and tolerability of CAR19-BCMA dual-target CAR-T in the treatment of relapsed / refractory multiple myeloma.
2. 2.To determine the maximum tolerated dose (MTD) of car19-bcma dual target car-t in the treatment of relapsed / refractory multiple myeloma.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• Incidence and Severity of Adverse Events

  An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

  in 3 months after CART infusion

• Laboratoty tests

  Abnormal results of laboratoty tests

  in 3 months after CART infusion

Secondary Outcomes (6)

• Overall response rate (ORR)

  Day28, Month2, Month3, Month6, Month12, Month18, Month24 after CAR-T infusion

• Minimal Residual Disease (MRD) negative rate

  Day28, Month2, Month3, Month6, Month12, Month18, Month24 after CAR-T infusion

• Overall Survival (OS)

  Minimum of 2 years post CAR-T infusion

• Progression-free Survival (PFS)

  Minimum of 2 years post CAR-T infusion

• Event-free Survival (EFS)

  Minimum of 2 years post CAR-T infusion

Study Arms (1)

CAR19-BCMA CAR-T

EXPERIMENTAL

This part follows the "3+3" dose escalation mode, with three dose groups (1E+06, 2E+06 and 3E+06 CAR+ cells /kg)

Drug: CAR19-BCMA dual-target CAR-T

Interventions

CAR19-BCMA dual-target CAR-T DRUG

This drug is CAR-T cell injection. CAR-T cells are based on the traditional CAR-T treatment, using cytokine combination amplification and improved transfection technology to change the activation mode of T cells.

CAR19-BCMA CAR-T

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must satisfy all the following criteria to be enrolled in the study:
• \. With Subjects' consent and signed informed consent, Subjects are willing and able to follow the planned visit, study treatment, laboratory examination and other test procedures; 2. Patients with relapsed / refractory multiple myeloma according to clinical diagnosis:
• The expression of BCMA and / or CD19 in myeloma cells was positive confimed by flow cytometry or immunohistochemistry;
• Patients with relapsed / refractory multiple myeloma who have received at least 1 line treatment (including proteasome inhibitors (PI), immunomodulatory drugs (IMID), CD38 mAb) or are resistant to proteasome inhibitors and / or immunomodulatory agents and / or CD38 mAb in the past.
• \. Age 18-70 years old, both male and female; 4. Subjects with physical fitness status of 0-2 in the Eastern Cooperative Oncology Group (ECOG) score; 5. The estimated survival time from the date of signing informed consent is more than 3 months; 6. Hgb ≥ 60g/L (transfusible); 7. Liver and kidney function and cardiopulmonary function meet the following requirements:
• Creatinine ≤ 2 × ULN;
• Left ventricular ejection fraction ≥ 50%;
• Blood oxygen saturation \>90%;
• Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; 8. Subjects with pregnancy plans must agree to take contraception before enrollment in the study and after six months of study duration; The investigator should be informed immediately if the subject is pregnant or suspected of pregnancy.

You may not qualify if:

• If any of the following criteria is met, you cannot be enrolled:
• \. There were severe cardiac insufficiency and left ventricular ejection fraction \<50%; 2. Have a history of severe lung function impairment disease; 3. Combined with other advanced malignant tumors; 4. It was complicated with serious infection and could not be effectively controlled; 5. Complicated with severe autoimmune disease or innate immune deficiency; 6. Active hepatitis (hepatitis B virus deoxyribonucleic acid \[hbv-dna\] or hepatitis C virus ribonucleic acid \[hcv-rna\] test results are higher than the lower limit of detection); 7. Human immunodeficiency virus (HIV) infection or known acquired immune deficiency syndrome (AIDS), or syphilis infection; 8. Have a history of severe allergy to biological products (including antibiotics); 9. One month after immunosuppressant withdrawal, patients with acute graft-versus-host response (GVHD) after allogeneic hematopoietic stem cell transplantation still exist; 10. There are other serious physical or mental diseases or abnormal laboratory tests that may increase the risk of participating in the study, or interfere with the results of the study, as well as patients who the investigator believes are not suitable for participating in this study; 11. Female patients (patients with fertility) are in pregnancy or lactation. Note: severe infection: refers to the infection with uncontrolled sepsis or infection focus, which can be enrolled after infection control.

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; ec@ihcams.ac.cn

Study Design

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

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: November 25, 2025
• Study Start: March 28, 2025
• Primary Completion (Estimated): March 27, 2028
• Study Completion (Estimated): March 27, 2029
• Last Updated: November 25, 2025

Record last verified: 2025-09

Locations

CN (1)