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Trial record 1 of 1 for:    NCT05436509
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CD19/79b Bi-specific CAR-T Cell Therapy

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ClinicalTrials.gov Identifier: NCT05436509
Recruitment Status : Recruiting
First Posted : June 29, 2022
Last Update Posted : June 29, 2022
Sponsor:
Information provided by (Responsible Party):
Shenzhen Geno-Immune Medical Institute

Tracking Information
First Submitted Date  ICMJE June 22, 2022
First Posted Date  ICMJE June 29, 2022
Last Update Posted Date June 29, 2022
Estimated Study Start Date  ICMJE June 30, 2022
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2022)		 Safety of fourth generation bi-4SCAR-CD19/79b T cells in patients with B cell malignancies [ Time Frame: 12 weeks ]
Safety of fourth generation bi-4SCAR-CD19/79b T cells in patients with B cell malignancies using CTCAE 4 standard to evaluate the level of adverse events standard to evaluate the level of adverse events
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2022)
  • Anti tumor activity of fourth generation bi-4SCAR-CD19/79b T cells in patients with relapsed or refractory B cell malignancies [ Time Frame: 1 year ]
    Scale of CAR copies (for efficacy)
  • Anti tumor activity of fourth generation bi-4SCAR-CD19/79b T cells in patients with relapsed or refractory B cell malignancies [ Time Frame: 1 year ]
    Scale of leukemic cell burden (for efficacy)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CD19/79b Bi-specific CAR-T Cell Therapy
Official Title  ICMJE CD19/79b Bi-specific CAR-T Cells Targeting B Cell Malignancies
Brief Summary The purpose of this study is to assess the feasibility, safety and efficacy of CD19/79b bi-specific CAR-T cell therapy in patients with CD19 and/or CD79b positive B cell malignancies. Another goal of the study is to learn more about the safety and function of the anti-CD19/79b bi-specific CAR-T cells and their persistency in patients.
Detailed Description

Patients with refractory and/or recurrent B cell malignancies have poor prognosis despite complex multimodal therapy. Despite impressive progress, more than 50% of patients treated with CD19-targeting chimeric antigen receptor T cells (CAR19) experience progressive disease. Further, more than 40% patients with progressive large B cell lymphoma (LBCL) experienced reduced or lost expression of CD19 on the tumor cells after CAR19 treatment; low surface CD19 density before treatment was associated with progressive disease. Therefore, novel curative approaches are needed. The investigation attempts to use genetically modified T cells to express a 4th generation lentiviral anti-CD19/79b bi-specific CAR (bi-4SCAR-CD19/79b). The CAR molecules enable the T cells to recognize and kill tumor cells through the recognition of a surface antigen, CD19 or CD79b, which is expressed at high levels on tumor cells but not at significant levels on normal tissues.

CD79b is a B cell surface antigen, which is a component of B cell receptor. CD79b is up-regulated in more than 90% of B-cell lymphomas. Recent studies have shown that CD79b CAR-T cells have potential in targeting B-cell lymphomas. In addition, several immunotherapy drugs based on targeting CD79b have been reported worldwide. The CD79b specific CAR-T cells with binding moiety of CD79b specific scFv exhibited a high affinity and antitumor effect against CD79b+ tumor cells.

A potential strategy to prevent relapse due to antigen escape is to infuse T-cells capable of recognizing multiple antigens. To overcome tumor escape of single target antigen and enhance in vivo CAR-T efficacy, a novel bi-specific CD19/79b CAR-T therapy regimen is developed to include booster and consolidation CAR-T applications to target highly-refractory B cell cancer. The aim is to evaluate safety and long term efficacy of the bi-CAR-T therapy strategy in CD19 and/or CD79b positive cancer patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE B Cell Malignancies
Intervention  ICMJE Biological: bi-4SCAR CD19/79b T cells
Infusion of bi-4SCAR-CD19/79b T cells at 10^6 cells/kg body weight via IV
Study Arms  ICMJE Experimental: bi-4SCAR-CD19/79b T Cell Therapy for CD19 and/or CD79b positive B cell malignancies
Intervention: Biological: bi-4SCAR CD19/79b T cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 28, 2022)		 60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2026
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. age older than 6 months.
  2. malignant B cell surface expression of CD19 or CD79b 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 patient response.
  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 CD19 and CD79b CAR-T treatment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lung-Ji Chang, PhD 86-0755-86725195 c@szgimi.org
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05436509
Other Study ID Numbers  ICMJE GIMI-IRB-22009
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Shenzhen Geno-Immune Medical Institute
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Shenzhen Geno-Immune Medical Institute
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shenzhen Geno-Immune Medical Institute
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP