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Trial record 1 of 1 for:    NCT05995015
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4SCAR19U T Cells Targeting B Cell Malignancies

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ClinicalTrials.gov Identifier: NCT05995015
Recruitment Status : Recruiting
First Posted : August 16, 2023
Last Update Posted : October 12, 2023
Sponsor:
Information provided by (Responsible Party):
Shenzhen Geno-Immune Medical Institute

Study Description
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Brief Summary:
The purpose of this study is to assess the feasibility, safety and efficacy of universal CAR T cell therapy against CD19-positive hematological malignancies using a novel CD19-specific CAR T cell product, 4SCAR19U T cells. The study also aims to learn more about the function of the 4SCAR19U T cells and their persistence in patients. This is a phase I trial enrolling patients from multiple clinical centers.

Condition or disease Intervention/treatment Phase
B Cell Malignancies Biological: Universal CD19-specific CAR gene-engineered T cells Phase 1

Detailed Description:

Chimeric antigen receptor (CAR) T cell therapy has proven effective in treating B cell malignancies. However, the application itself is still limited by the high cost and long preparation time which often do not meet the urgent need of patients. In addition, some patients may suffer from long-term immunosuppression caused by tumor microenvironment or after radiotherapy and chemotherapy, resulting in exhaustion, aging and functional defects of the autologous T cells, which will eventually affect the quality of the CAR-T cells and affect the clinical efficacy.

The 4SCAR19U T cells are genetically engineered and manufactured in bulk amount that can be supplied off-the-shelf without being custom made from individual patients. The immediate availability of the CAR-T cells makes clinical treatment convenient and timely for rapid progressing disease or for the highly immune suppressed patients. This application can be time- and cost-effective. This novel approach may also overcome problems of functionally defective autologous T cells. The purpose of this clinical trial is to assess the feasibility, safety and efficacy of the 4SCAR19U T cell product in hematological malignancies. Another goal of the study is to learn more about the function of this novel product and its persistence in the patients

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Universal 4SCAR19U T Cell Therapy for the Treatment of Relapsed and Refractory B Cell Malignancies
Estimated Study Start Date : October 31, 2023
Estimated Primary Completion Date : September 30, 2026
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arms and Interventions
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Arm Intervention/treatment
Experimental: Universal 4SCAR19U cells to treat CD19-positive hematological malignancies Biological: Universal CD19-specific CAR gene-engineered T cells
Infusion of 4SCAR19U cells


Outcome Measures
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Primary Outcome Measures :
  1. Safety of 4SCAR19U CAR-T cells infusion [ Time Frame: 24 weeks ]
    Safety of 4SCAR19U T cells in patients with relapsed and refractory B-ALL, BCL using CTCAE 4 standard to evaluate the level of adverse events


Secondary Outcome Measures :
  1. Anti-tumor activity of 4SCAR19U cells after 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.


Eligibility 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 surface expression of CD19.
  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 or HCV infection.
  5. Pregnant and nursing mothers.
  6. under systemic steroid treatment within a week of the treatment.
  7. Prior failed CAR-T treatment.
Contacts and Locations
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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): NCT05995015


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 Geno-Immune Medical Institute Recruiting
Shenzhen, Guangdong, China, 518000
Contact: Lung-Ji Chang, Ph.D    +86-0755 8672-5195    c@szgimi.org   
Sponsors and Collaborators
Shenzhen Geno-Immune Medical Institute
More Information
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Responsible Party: Shenzhen Geno-Immune Medical Institute
ClinicalTrials.gov Identifier: NCT05995015    
Other Study ID Numbers: GIMI-IRB-23001
First Posted: August 16, 2023    Key Record Dates
Last Update Posted: October 12, 2023
Last Verified: October 2023
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:
Universal CAR-T
CD19 B-ALL
PMBCL
CNS-BCL
BCL
Additional relevant MeSH terms:
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Neoplasms