Dual-target BCMA-CD19 CAR-T Cell Therapy for RR/MM With Extramedullary Infiltration

NCT07003555 | Recruiting Phase 1 DMC

• 1 other identifier: BJGBYY-IIT-LCYJ-2025-031
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, open-label, non-randomized, single-arm clinical trial. Patients with relapsed/refractory multiple myeloma accompanied by extramedullary infiltration will receive BCMA - CD19 CAR-T cell therapy. The primary objective is to prospectively evaluate the safety of dual-targeting BCMA and CD19 CAR - T cell therapy for extramedullary infiltration in relapsed/refractory multiple myeloma. The primary endpoints are to assess the type and incidence of dose-limiting toxicity (DLT) within one month after the infusion of BCMA-CD19 CAR-T cells in patients, as well as the incidence and severity of adverse events within one month after the infusion. It is expected that no more than 18 participants will be recruited.

Conditions

Relapsed or Refractory Multiple Myeloma (RRMM)

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity (DLT)

  Incidence and type of dose-limiting toxicity(DLT) within 1 month of BCMA-CD19 CAR-T infusion.

  30 days

• Adverse events (AEs）

  Total number, incidence and severity of adverse events (AEs) within 30 days of BCMA-CD19 CAR-T infusion

  30 days

Secondary Outcomes (4)

• Overall remission rate (ORR)

  90 days

• Event Free Survival (EFS)

  from enrollment to the end of treatment at 2 years

• Duration of Response (DOR)

  from enrollment to the end of treatment at 2 years

• Overall Survival (OS)

  from enrollment to the end of treatment at 2 years

Study Arms (1)

Dual-targeting BCMA-CD19 CAR-T cell therapy

EXPERIMENTAL

Patients receive dual-targeting BCMA-CD19 CAR-T cell therapy

Drug: Dual-targeting BCMA-CD19 CAR-T cell infusion

Interventions

Dual-targeting BCMA-CD19 CAR-T cell infusion DRUG

Approximately 3-5 days prior to BCMA-CD19 CAR-T cell infusion, subjects are treated with FC regimen (fludarabine and cyclophosphamide) for lymphodepletion. CAR-T cell infusion are performed 48 h after completion of chemotherapy.

Dual-targeting BCMA-CD19 CAR-T cell therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily participate in the trial and have good compliance.
• Aged between 18 and 75 years old, regardless of gender.
• Diagnosed with relapsed or refractory multiple myeloma according to the criteria of the International Myeloma Working Group (IMWG)2, and have measurable extramedullary lesions due to multiple myeloma.
• Positive for BCMA in flow cytometry of bone marrow or cerebrospinal fluid tumor cells or immunohistochemistry of tumor tissue.
• Organ functions: ① Cardiac function: Left ventricular ejection fraction \> 50% (by echocardiogram) in the past 2 weeks. ② Liver function: Alanine aminotransferase and aspartate aminotransferase \< 3 times the upper limit of normal (ULN). ③ Renal function: Creatinine clearance rate ≥ 40 mL/min (by Cockcroft and Gault formula). ④ Coagulation function: PT and APPT \< 1.5 times the ULN. ⑤ Arterial oxygen saturation (SpO₂) \> 95%. ⑥ Pulmonary function: FEV₁% predicted value ≥ 50%.
• Female patients of childbearing age must have a negative serum pregnancy test at screening and before receiving cyclophosphamide and fludarabine or melphalan treatment; male patients should be willing to use effective contraceptive methods for 1 year after receiving the study treatment.
• ECOG score ≤ 2.
• Expected survival time \> 3 months.

You may not qualify if:

• Pregnant or lactating women.
• Active infections that have not been effectively controlled.
• Active autoimmune diseases that have not been effectively controlled.
• Adverse reactions caused by previous treatments have not recovered to CTCAE grade ≤ 1.
• For allogeneic transplant patients, active graft - versus - host disease (GVHD) that has not been effectively controlled.
• Presence of any of the following: HBV - DNA copy number above the lower limit of detection; positive hepatitis C antibody (HCV - Ab) with HCV - RNA copy number above the lower limit of measurability; positive anti - Treponema pallidum antibody (TP - Ab); positive human immunodeficiency virus (HIV) antibody test.
• Allergic or intolerant to fludarabine or cyclophosphamide.
• Suffering from known symptomatic non - plasma cell infiltrative central nervous system diseases.
• Uncontrollable cardiovascular and cerebrovascular diseases within 6 months, such as: a. New York Heart Association (NYHA) class III or IV congestive heart failure. b. Myocardial infarction occurred or coronary artery bypass grafting (CABG) was received ≤ 6 months before enrollment. c. Clinically significant ventricular arrhythmia or a history of unexplained syncope (excluding cases caused by vasovagal or dehydration). d. A history of severe non - ischemic cardiomyopathy.
• A history of other untreated malignancies within the past 5 years or having other untreated malignancies concurrently.
• The investigator assesses that the subject cannot or is unwilling to comply with the requirements of the study protocol.
• Previous use of a CAR - T vector with the same structure.

Sponsors & Collaborators

• Beijing GoBroad Hospital: lead
• Shanghai Liquan Hospital: collaborator
• Ruijin Hospital: collaborator

Study Sites (1)

Shanghai Liquan Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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

Central Study Contacts

Yao Yao

CONTACT

86+13101898518; yaoy01@gobroadhealthcare.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the department of Immunotherapy for Hematopoietic Malignancies

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 4, 2025
• Study Start: May 25, 2025
• Primary Completion (Estimated): May 25, 2027
• Study Completion (Estimated): June 25, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

CN (1)