The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT05436496
Previous Study | Return to List | Next Study

CD19/70 Bi-specific CAR-T Cell Therapy

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: NCT05436496
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-4SCARCD19/70 T cells in patients with B cell malignancies [ Time Frame: 12 weeks ]
Safety of fourth generation bi-4SCARCD19/70 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-4SCARCD19/70 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-4SCARCD19/70 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 CD19/70 Bi-specific CAR-T Cell Therapy
Official Title  ICMJE CD19/70 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 CD19/70 bi-specific CAR-T cell therapy in patients with CD19 and/or CD70 positive B cell malignancies. Another goal of the study is to learn more about the safety and function of the anti-CD19/70 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-CD19/70 bi-specific CAR (bi-4SCAR-CD19/70). The CAR molecules enable the T cells to recognize and kill tumor cells through the recognition of a surface antigen, CD19 or CD70, which is expressed at high levels on tumor cells but not at significant levels on normal tissues.

CD70 is highly expressed in many cancers, but limited in normal tissues, it is a potential CAR-T therapeutic target. Expression of CD70 was observed on multiple tumor types including solid tumor as well as B cell malignancies. In addition, it has been reported that anti-CD70 CAR T-cells can eliminate CD70-positive cells and exhibit strong anti-tumor effects in preclinical animal models. The CD70 targeted CAR-T cells with binding moiety of CD70 specific scFv exhibited a higher affinity and antitumor effect against CD70-positive 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 CD19/70 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 CD70 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 CD19/70 T cells
Infusion of bi-4SCAR CD19/70 T cells at 10^6 cells/kg body weight via IV
Study Arms  ICMJE Experimental: bi-4SCAR-CD19/70 T Cell Therapy for CD19 and/or CD70 positive B cell malignancies
Intervention: Biological: bi-4SCAR CD19/70 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)		 30
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 CD70 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 CD70 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 NCT05436496
Other Study ID Numbers  ICMJE GIMI-IRB-22008
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