BCMA-CD19 cCAR in Multiple Myeloma and Plasmacytoid Lymphoma

September 10, 2025 updated by: iCell Gene Therapeutics

BCMA-CD19 cCAR in Relapsed and /or Refractory Multiple Myeloma and Plasmacytoid Lymphoma

This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of BCMA-CD19 cCAR in patients with relapsed and/or refractory multiple myeloma and plasmacytoid lymphoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

BCMA-CD19 cCAR is a compound Chimeric Antigen Receptor (cCAR) immunotherapy with two distinct functional CAR molecules expressing on a T-cell, directed against the surface proteins BCMA and CD19. BCMA-CD19 cCAR is also aimed to treat multiple myeloma, a challenging disease due to the heterogeneity of myeloma cells, which renders single-antigen targeting CAR T-cell therapy ineffective. BCMA-CD19 cCAR is proposed to target both bulky myeloma cells expressing BCMA, and myeloma stem cells expressing CD19 to effectively eradicate the disease.

BCMA-CD19 cCAR is also aimed to treat heterogeneous plasmacytoid lymphoma bearing two types of lymphoma cells, regular lymphoma cells expressing CD19 and plasmacytoid lymphoma cells expressing BCMA. The use of two different targets intends to increase coverage and eradicate cancerous cells before resistance develops in surviving cancer cells that have undergone selective pressures or antigen escape.

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China
        • Recruiting
        • Peking University Shenzhen Hospital, China
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • Chengdu Military General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Signed written informed consent; Patients volunteer to participate in the research
  • Diagnosis is mainly based on the World Health Organization (WHO) 2008
  • Patients have exhausted standard therapeutic options
  • Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 weeks
  • Female must be not pregnant during the study

Exclusion Criteria:

  • Patients declining to consent for treatment
  • Prior solid organ transplantation
  • Potentially curative therapy including chemotherapy or hematopoietic cell transplant
  • Prior treatment with BCMAxCD3 or CD19xCD3 bispecific agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BCMA-CD19 cCAR
Dose escalation phase: BCMA-CD19 cCAR T cells transduced with a lentiviral vector to express two distinct units of BCMA and CD19 CARs on a T cell with an escalation approach, 2e6 to 10e6 CAR-T cells/kg
Biological: BCMA-CD19 cCAR T cells
BCMA-CD19 cCAR T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of adverse events after BCMA-CD19 cCAR T cells infusion
Time Frame: 2 years particularly the first 28 days after infusion
Determine the toxicity profile of BCMA-CD19 cCAR T cell therapy
2 years particularly the first 28 days after infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment-emergent adverse events
Time Frame: up to 6 months
Incidence of treatment-emergent adverse events
up to 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
For multiple myeloma - Stringent complete response
Time Frame: 24 months
Stringent complete response (sCR) (IMWG criteria)
24 months
For multiple myeloma - Complete response (CR)
Time Frame: 24 months
Complete response (CR) (IMWG criteria)
24 months
For multiple myeloma - Very good partial response (VGPR)
Time Frame: 24 months
Very good partial response (VGPR) (IMWG criteria)
24 months
For multiple myeloma - Partial response (PR)
Time Frame: 24 months
Partial response (PR) (IMWG criteria)
24 months
For multiple myeloma - Minimal response (MR)
Time Frame: 24 months
Minimal response (MR) (IMWG criteria)
24 months
For multiple myeloma - Stable disease (SD)
Time Frame: 24 months
Stable disease (SD) (IMWG criteria)
24 months
For multiple myeloma - Progressive disease (PD)
Time Frame: 12 months
Progressive disease (PD) (IMWG criteria)
12 months
For multiple myeloma - Progression-free survival (PFS)
Time Frame: up to 24 months
Progression-free survival (PFS) (IMWG criteria)
up to 24 months
For plasmacytoid lymphoma - Assessment of morphologic CR, CR1, no residual disease, and molecular remission
Time Frame: 1 year
Assessment of morphologic complete remission (CR), complete remission with incomplete recovery of counts (CR1), no residual disease as analyzed by flow cytometry analysis, and molecular remission by molecular studies
1 year
For plasmacytoid lymphoma - Progression-free survival (PFS)
Time Frame: 1 year
Progression-free survival (PFS)
1 year
For plasmacytoid lymphoma - Overall survival
Time Frame: 1 year
Overall survival
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

iCell Gene Therapeutics

Collaborators

Peking University Shenzhen Hospital
iCAR Bio Therapeutics Ltd.

Investigators

  • Principal Investigator: Fang Liu, MD/PhD, Chengdu Military General Hospital
  • Principal Investigator: Hongyu Zhang, MD/PhD, Peking University Shenzhen Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

November 11, 2019

First Submitted That Met QC Criteria

November 11, 2019

First Posted (Actual)

November 14, 2019

Study Record Updates

Last Update Posted (Estimated)

September 16, 2025

Last Update Submitted That Met QC Criteria

September 10, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICG185-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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