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NCT Number: NCT04162353

BCMA-CD19 cCAR in 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BCMA-CD19 cCAR T cells

Biological

BCMA-CD19 cCAR T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy

Primary outcomes

  1. 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

Secondary outcomes

  1. Incidence of treatment-emergent adverse events

    Time frame: up to 6 months

    Incidence of treatment-emergent adverse events

Other outcomes

  1. For multiple myeloma - Stringent complete response

    Time frame: 24 months

    Stringent complete response (sCR) (IMWG criteria)

  2. For multiple myeloma - Complete response (CR)

    Time frame: 24 months

    Complete response (CR) (IMWG criteria)

  3. For multiple myeloma - Very good partial response (VGPR)

    Time frame: 24 months

    Very good partial response (VGPR) (IMWG criteria)

  4. For multiple myeloma - Partial response (PR)

    Time frame: 24 months

    Partial response (PR) (IMWG criteria)

  5. For multiple myeloma - Minimal response (MR)

    Time frame: 24 months

    Minimal response (MR) (IMWG criteria)

  6. For multiple myeloma - Stable disease (SD)

    Time frame: 24 months

    Stable disease (SD) (IMWG criteria)

  7. For multiple myeloma - Progressive disease (PD)

    Time frame: 12 months

    Progressive disease (PD) (IMWG criteria)

  8. For multiple myeloma - Progression-free survival (PFS)

    Time frame: up to 24 months

    Progression-free survival (PFS) (IMWG criteria)

  9. 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

  10. For plasmacytoid lymphoma - Progression-free survival (PFS)

    Time frame: 1 year

    Progression-free survival (PFS)

  11. For plasmacytoid lymphoma - Overall survival

    Time frame: 1 year

    Overall survival

Study contacts

Contact information is provided by the study sponsor or research team.

Kevin Pinz, MS

CONTACT

[email protected]

6315386218

Sponsors and collaborators

Lead sponsor

iCell Gene Therapeutics

Industry

Collaborators

  • Peking University Shenzhen Hospital
  • iCAR Bio Therapeutics Ltd.

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Nov 14, 2019
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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