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NCT Number: NCT04429438

Multi-CAR-T Cells Targeting B Cell Lymphomas

This study aims to evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells targeting B cell surface molecules including CD19 and alternative CARTs as booster and consolidation treatment for patients with highly resistant B cell lymphomas, including primary mediastinal B cell lymphoma (PMBCL) and BCL involving central nervous system (CNS-BCL). Clinical response and development of a simplified and standardized lentiviral vector and cell production protocol will be investigated. This is a phase I/II trial enrolling patients from multiple clinical centers.

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Key information

Conditions

B Cell Lymphoma (BCL) Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

6 month–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Shenzhen Geno-Immune Medical Institute

Shenzhen, Guangdong, 518000, China

Location status: Recruiting

Location contact

Lung-Ji Chang, Ph.D

CONTACT

[email protected]

+86 0755 86573763

About this study

Chimeric antigen receptor (CAR) T cell therapy has proven effective in treating B cell malignancies. However, post CD19-CART relapses occur at high rate due to the CD19 antigen loss or the exhaustion of CART cells. Furthermore, the success of treating relapsed/refractory B cell lymphoma (BCL) such as primary mediastinal B-cell lymphoma (PMBCL) and CNS-involved BCL has been limited. To overcome tumor escape and prolong in vivo CART efficacy, we have developed a novel multiple CAR-T therapy regimen including booster and consolidation CART applications to to target highly-refractory cancer. Selected patients will be enrolled after target antigen confirmation including CD19, CD20, CD22, CD70, CD13, CD79b, GD2 and PSMA through immunostaining of their tumor specimens. The aim is to evaluate safety and long term efficacy of the multiple CART therapy strategy in the BCL patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age older than 6 months.
  • Primary B cell lymphoma surface expression of CD19 and/or CD22/CD70/PSMA/ CD13/CD79b/GD2 molecules.
  • The KPS score over 80 points, and survival time is more than 1 month.
  • Greater than Hgb 80 g/L.
  • No contraindications to blood cell collection.

Exclusion criteria

  • Accompanied with other active diseases, and difficult to assess response after treatment.
  • Bacterial, fungal, or viral infection, unable to control.
  • Living with HIV.
  • Active HBV and HCV infection.
  • Pregnant and nursing mothers.6. under systemic steroid treatment within a week of the treatment.
  • Prior failed CAR-T treatment.

Treatment and study plan

4SCAR19 and 4SCAR20/22/70/PSMA/13/79b/GD2

Biological

Patients who have relapsed and refractory B cell lymphoma (BCL) after conventional chemotherapy will be treated with multiple 4SCAR gene-engineered T cells

Primary outcomes

  1. Safety of fourth generation anti-CD19 and anti-CD20/CD22/CD70/PSMA/CD13/CD79b/GD2 CAR-T cells infusion

    Time frame: 24 weeks

    Safety of fourth generation anti-CD19 and anti-CD20/CD22/CD70/PSMA/CD13/CD79b/GD2 CAR-T cells in patients with relapsed B cell lymphoma (BCL) using CTCAE 4 standard to evaluate the level of adverse events

Secondary outcomes

  1. Anti tumor activity of fourth generation anti-CD19 and anti-CD20/CD22/CD70/PSMA/CD13/CD79b/GD2 CAR-T cells infusion

    Time frame: 1 year

    Objective responses (complete response (CR) + partial response (PR)) are assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.

Study contacts

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

Lung-Ji Chang, Ph.D

CONTACT

[email protected]

+86 0755 86573763

Sponsors and collaborators

Lead sponsor

Shenzhen Geno-Immune Medical Institute

Other

Registry information

Official study title

Primary, Booster and Consolidation Multi-CAR-T Cell Therapy for the Treatment of Refractory B Cell Lymphomas

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jun 12, 2020
Registry last updated
Jun 23, 2026

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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