CAR19BCMA CAR-T Cells for the Treatment of R/R Plasma Cell Neoplasms

NCT ID: NCT06986434

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-26
• Study Completion Date: 2028-08-25

Brief Summary

This is a single arm study to evaluate the safety and efficacy of CAR19BCMA CAR-T cells in the treatment of relapsed/refractory CD19/BCMA positive plasma cell neoplasms.

Detailed Description

This study is an exploratory clinical trial of a single-arm, open, single-center treatment of CAR19BCMA CAR-T cell. 20 subjects with relapsed or refractory CD19/ BCMA positive positive plasma cell neoplasms will be enrolled and received CAR19BCMA CAR T cells injection therapy, and related data such as adverse reactions and therapeutic effects after medication were followed up. To evaluate its safety and efficacy.

Conditions

Relapsed or Refractory Plasma Cell Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

This is a single arm treatment of CAR19BCMA CAR-T cell

Experimental: CAR19BCMA-T cells Therapy Investigational product: CAR19BCMA-T cells Route of administration: Intravenous injection Lymphodepleting chemotherapy regimen: A combination of fludarabine and cyclophosphamide will be administered prior to the infusion of CD19BCMA-CAR-T cells.

Group Type: EXPERIMENTAL

CAR19BCMA-T cells

Intervention Type: GENETIC

CAR19BCMA-T cells Each subject will be infused with single dose of CD19BCMA-CAR-T cells. A classic "3+3" dose escalation will be employed. The low dose is 1×10\^6 /kg, the medium dose is 2×10\^6 /kg, and the high dose is 3×10\^6 /kg.

fludarabine and cyclophosphamide

Intervention Type: DRUG

Drug: Fludarabine Fludarabine will be given at a dose of 30 mg/m2/day intravenously (IV) for 3 days prior to the infusion of CD19BCMA-CAR-T cells.

Drug: Cyclophosphamide Cyclophosphamide will be given at a dose of 300 mg/m2/day intravenously (IV) for 3 days prior to the infusion of CD19BCMA-CAR-T cells.

Interventions

CAR19BCMA-T cells

CAR19BCMA-T cells Each subject will be infused with single dose of CD19BCMA-CAR-T cells. A classic "3+3" dose escalation will be employed. The low dose is 1×10\^6 /kg, the medium dose is 2×10\^6 /kg, and the high dose is 3×10\^6 /kg.

Intervention Type: GENETIC

fludarabine and cyclophosphamide

Drug: Fludarabine Fludarabine will be given at a dose of 30 mg/m2/day intravenously (IV) for 3 days prior to the infusion of CD19BCMA-CAR-T cells.

Drug: Cyclophosphamide Cyclophosphamide will be given at a dose of 300 mg/m2/day intravenously (IV) for 3 days prior to the infusion of CD19BCMA-CAR-T cells.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Relapsed/refractory CD19BCMA positive plasma cell neoplasms must be assured and meet all of the following conditions:

①Confirmation for either BCMA or CD19 positivity using immunohistochemistry or flow cytometry.

②Patients with multiple myeloma, plasma cell carcinoma, and plasma cell leukemia who have received at least three 3 lines treatment (including anti-CD38 monoclonal antibodies, protease inhibitors, immunosuppressants, etc.) but have failed or experienced relapse.

③Patients with system light chain amyloidosis who have received at least 2 lines treatments in the past [anti-CD38 monoclonal antibody, proteasome inhibitor (PI), or immunomodulatory drug (IMiD)], but have failed or experienced relapse.

Age 18-80 years, no gender restrictions; ECOG score ≤ 2 points; Expected survival period is not less than 3 months; HGB≥60g/L; Liver function and cardiopulmonary function meet the following requirements: (1) left ventricular ejection fraction≥50%; (2) Oxygen saturation >90%; (3)Total bilirubin ≤1.5×ULN, ALT and AST≤2.5×ULN; Participants agreed to use contraception from the time of informed consent until 1 year after CAR-T cell infusion.

Exclusion Criteria

Severe heart failure with left ventricular ejection fraction <50%; A history of severe lung function impairment; Combined with other advanced malignant tumors; Complicated with severe infection that could not be effectively controlled; Severe autoimmune disease or congenital immune deficiency; Active hepatitis (hepatitis B virus DNA [HBV-DNA] or hepatitis C virus RNA [HCV-RNA] test results above the lower limit of detection); Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection; History of severe allergy to biological products (including antibiotics); Patients with other serious physical or mental illnesses or laboratory abnormalities that could increase the risk of participating in the study or interfere with the results of the study, and those who were deemed by the investigator to be unsuitable for participation in the study.

Female patients (those with fertility) are in pregnancy or lactation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Affiliated Hospital to Academy of Military Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

the Fifth Medical Center of Chinese People's Liberation Army General Hospital

Beijing, , China

Countries

China

Central Contacts

Hongmei Ning, Dr

Role: CONTACT

ninghongmei72@sina.com

+86 01066947164

Other Identifiers

CAR19BCMA-XYBYXB

Identifier Type: -

Identifier Source: org_study_id