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

Early Phase 1

Not yet recruiting

• Conditions: Relapsed or Refractory Plasma Cell Neoplasms
• Interventions: Genetic: CAR19BCMA-T cells; Drug: fludarabine and cyclophosphamide

• Registration Number: NCT06986434
• Lead Sponsor: Affiliated Hospital to Academy of Military Medical Sciences

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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-15
• Study First Submitted QC: 2025-05-15
• Last Update Submitted: 2025-05-15
• Study Start: 2025-05-22
• Study First Posted: 2025-05-23
• Last Update Posted: 2025-05-23
• Primary Completion: 2027-05-22
• Study Completion: 2028-05-22

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
This is a single arm treatment of CAR19BCMA CAR-T cell	CAR19BCMA-T cells	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.
This is a single arm treatment of CAR19BCMA CAR-T cell	fludarabine and cyclophosphamide	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.

Primary Outcome Measures

Name	Time	Method
According to the determine the Maximal Tolerable Dose(MTD) to evaluate the safety of CAR19BCMA CAR-T cells in the treatment of relapsed/refractory CD19+BCMA+ plasma cell neoplasms.	MTD will be determined based on DLTs observed during the first 28 days of study treatment
According to the incidence of treatment-related adverse events (AEs) to evaluate the safetyof CAR19BCMA CAR-T cells in the treatment of relapsed/refractory CD19+BCMA+plasma cell neoplasms.	up to 3 years	Incidence of treatment-related adverse events (AEs) Description: Number and severity of adverse events graded according to CTCAE v5.0, including cytokine release syndrome (CRS) graded by ASTCT criteria and immune effector cell-associated neurotoxicity syndrome (ICANS) graded by ASBMT criteria

Secondary Outcome Measures

Name	Time	Method
According to the objective response rate (ORR) to evaluate the efficacy of CAR19BCMA CAR-T cells in the treatment of relapsed/refractory CD19+BCMA+ plasma cell neoplasms.	Within 3 months following infusion of CAR19BCMA CAR-T cells	Overall response rate (ORR) Description: Multiple myeloma (plasma cell neoplasms, plasma cell leukemia) refers to the efficacy evaluation criteria in the Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma (revised in 2024),ORR includes strictly defined proportions of complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), and minimal response (MR).

Trial Locations

Locations (1)

the Fifth Medical Center of Chinese People's Liberation Army General Hospital; 🇨🇳 Beijing, China