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

NCT07077330 | Not Yet Recruiting Early Phase 1

• 2 other identifiers: 2025-653-012025KY072-KS001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Relapsed or Refractory Plasma Cell Neoplasms

Keywords

CAR-T; plasma cell neoplasms; CD19/BCMA

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.

  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.

  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.

  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

Other: CAR19BCMA-T cells

Interventions

CAR19BCMA-T cells OTHER

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. Drug: 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

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 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, 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.
• 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 18-75 years,
• no gender restrictions;
• ECOG score ≤ 2 points;
• Expected survival period is not less than 3 months;
• HGB≥60g/L;
• Liver and kidney function and cardiopulmonary function meet the following requirements: (1) Creatinine ≤ 2× ULN; (2)left ventricular ejection fraction≥50%; (3) Oxygen saturation \>90%; (4)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 viral hepatitis (defined as positive hepatitis B virus DNA \[HBV-DNA\] or hepatitis C virus RNA \[HCV-RNA\] detection, with test results exceeding the lower limit of quantification); Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection;
• History of severe allergy to biological products (including antibiotics);
• Allogeneic hematopoietic stem cell transplant patients who still have an acute graft-versus-host response (GVHD) one month after discontinuation of immunosuppressants;
• 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

• Chinese PLA General Hospital: lead

Study Sites (2)

The Four Medical Center of PLA General Hospital, China

Beijing, China

Location

The Six Medical Center of PLA General Hospital, China

Beijing, China

Location

MeSH Terms

Conditions

Recurrence; Neoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Yi Liu Dr

CONTACT

+86 186 0031 0985; 18600310985@163.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: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: CAR-T

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 22, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)