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Multi-CAR-T Cells Targeting B Cell Lymphomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04429438
Recruitment Status : Recruiting
First Posted : June 12, 2020
Last Update Posted : June 12, 2020
Sponsor:
Collaborators:
The Seventh Affilliated Hospital, Sun Yat-Sen University
Shenzhen Children's Hospital
Information provided by (Responsible Party):
Shenzhen Geno-Immune Medical Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
B Cell Lymphoma (BCL) Biological: 4SCAR19 and 4SCAR20/22/70/PSMA/13/79b/GD2 Phase 1 Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Primary, Booster and Consolidation Multi-CAR-T Cell Therapy for the Treatment of Refractory B Cell Lymphomas
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : July 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma Scars

Arm Intervention/treatment
Experimental: 4SCAR19 and 4SCAR20/22/70/PSMA/13/79b/GD2
Patients who have relapsed and refractory B cell lymphoma (BCL) after chemotherapy will be treated with a combination of 4SCAR gene-engineered T cells.
Biological: 4SCAR19 and 4SCAR20/22/70/PSMA/13/79b/GD2
Patients who have relapsed and refractory B cell lymphoma (BCL) after conventional chemotherapy will be treated with multiple 4SCAR gene-engineered T cells




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   6 Months to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Accompanied with other active diseases, and difficult to assess response after treatment.
  2. Bacterial, fungal, or viral infection, unable to control.
  3. Living with HIV.
  4. Active HBV and HCV infection.
  5. Pregnant and nursing mothers.6. under systemic steroid treatment within a week of the treatment.

7. Prior failed CAR-T treatment.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04429438


Contacts
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Contact: Lung-Ji Chang, Ph.D +86-0755 8672-5195 c@szgimi.org

Locations
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China, Guangdong
Shenzhen Children's Hospital Recruiting
Shenzhen, Guangdong, China, 518000
Contact: Sixi Liu, MD    86-189 3869 0206    tiger647@126.com   
Contact: Lichun Xie, MD    86-19925192721    xielichunst@sina.com   
Shenzhen Geno-Immune Medical Institute Recruiting
Shenzhen, Guangdong, China, 518000
Contact: Lung-Ji Chang, Ph.D    +86-0755 8672-5195    c@szgimi.org   
The Seventh Affilliated Hospital, Sun Yat-Sen University Recruiting
Shenzhen, Guangdong, China, 518107
Contact: Bo Wang, MD    86-0755-23242570    wangb68377@sina.com   
Sponsors and Collaborators
Shenzhen Geno-Immune Medical Institute
The Seventh Affilliated Hospital, Sun Yat-Sen University
Shenzhen Children's Hospital
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Responsible Party: Shenzhen Geno-Immune Medical Institute
ClinicalTrials.gov Identifier: NCT04429438    
Other Study ID Numbers: GIMI-IRB-20006
First Posted: June 12, 2020    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shenzhen Geno-Immune Medical Institute:
CAR-T
CD19
CD20
CD22
CD70
PSMA
CD13
CD79b
GD2
PMBCL
CNS-BCL
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin