CAR19BCMA CAR-T Cells for the Treatment of R/R Plasma Cell Neoplasms and Lymphomas/Leukemias With Plasmacytic Differentiation

NCT06986434 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: CAR19BCMA-XYBYXB
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 and lymphomas/leukemias with plasmacytic differentiation.

Conditions

Lymphomas/Leukemias With Plasmacytic Differentiation; Relapsed or Refractory Plasma Cell Neoplasms

Keywords

CAR-T; plasma cell neoplasms; CD19/BCMA; lymphomas/leukemias with plasmacytic differentiation

Outcome Measures

Primary Outcomes (2)

• 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 and lymphomas/leukemias with plasmacytic differentiation.

  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

  up to 3 years

• 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 and lymphomas/leukemias with plasmacytic differentiation.

  MTD will be determined based on DLTs observed during the first 28 days of study treatment

Secondary Outcomes (1)

• 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 and lymphomas/leukemias with plasmacytic differentiation.

  Within 3 months following infusion of CAR19BCMA CAR-T cells

Other Outcomes (1)

• According to the pharmacokinetics (number of CAR-T cells in peripheral blood was measured to evaluate the persistence of CAR-T cells) to explore the kinetics and clonal evolution of CAR19BCMA CAR-T cells.

  Up to 12 months after CAR-T treatment

Study Arms (1)

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

EXPERIMENTAL

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.

Genetic: CAR19BCMA-T cells; Drug: fludarabine and cyclophosphamide

Interventions

CAR19BCMA-T cells 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.

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

fludarabine and cyclophosphamide 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.

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

Eligibility Criteria

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

You may qualify if:

• Relapsed/refractory CD19BCMA positive plasma cell neoplasms and lymphomas/leukemias with plasmacytic differentiation must be assured and meet all of the following conditions:
• Confirmation for either BCMA or CD19 positivity using immunohistochemistry or flow cytometry
• Patients with multiple myeloma, plasma cell carcinoma, plasma cell leukemia and lymphomas/leukemias with plasmacytic differentiation who have received at least three 3 lines treatment (including anti-CD38 monoclonal antibodies, protease inhibitors, immunosuppressants, etc.) but have failed or experienced relapse
• Patients 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:
• left ventricular ejection fraction≥50%
• Oxygen saturation \>90%
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Affiliated Hospital to Academy of Military Medical Sciences: lead

Study Sites (1)

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

Beijing, China

Location

MeSH Terms

Conditions

Recurrence; Neoplasms, Plasma Cell; Lymphoma

Interventions

fludarabine; Cyclophosphamide

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Central Study Contacts

Hongmei Ning, Dr

CONTACT

+86 01066947164; ninghongmei72@sina.com

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: May 15, 2025
• First Posted: May 23, 2025
• Study Start: April 2, 2026
• Primary Completion (Estimated): May 22, 2027
• Study Completion (Estimated): August 25, 2028
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)