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CAR-T Immunotherapy Targeting CD19- ALL

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: NCT04016129
Recruitment Status : Recruiting
First Posted : July 11, 2019
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Shenzhen Geno-Immune Medical Institute

Study Description
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Brief Summary:
This study will evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells targeting CD19 negative ALL that express CD22, CD123, CD38, CD10, CD20 and TSLPR, as many patients developed CD19-negative disease after CD19 CART immunotherapy. Clinical response and development of a 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 Leukemia Biological: 4SCAR-CD22/CD123/CD38/CD10/CD20/TSLPR Phase 1 Phase 2

Detailed Description:

Anti-CD19 chimeric antigen receptor T cell therapy has demonstrated unprecedented treatment responses in relapsing/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). However, many studies have reported that a subset of patients still relapse and about 30-50% of those relapses are characterized by the loss of CD19 surface antigen. Patients with CD19-negative relapse after CD19 CAR-T-cell therapy usually have a poor prognosis. The mechanisms underlying CD19-negative relapses are not fully understood and it is important to develop solutions to supplement post-CD19 immunotherapies.

Potential markers for recurrent leukemic blasts in an emerging CD19-negative blast population include many known B-cell lineage antigens. To prevent further target escape and improve the therapeutic effects, CAR gene-modified T cells targeting CD22, CD123, CD38, CD10, CD20 or TSLPR have been considered in post CD19 CAR-T immunotherapy. This study aims to evaluate safety and efficacy of administrating one or multiple non-CD19 targeting CAR-T cells to patients with CD19-negative B cell malignancies.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CART Immunotherapy Targeting CD19 Negative Acute Lymphoblastic Leukemia
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : July 15, 2021
Estimated Study Completion Date : December 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arms and Interventions
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Arm Intervention/treatment
Experimental: 4SCAR-CD22/CD123/CD38/CD10/CD20/TSLPR
Patients who have relapsed after CD19 CART immunotherapy or have CD19 negative B cell malignancies
 Biological: 4SCAR-CD22/CD123/CD38/CD10/CD20/TSLPR
4SCAR-CD22/CD123/CD38/CD10/CD20/TSLPR Patients who have relapsed after CD19 CART immunotherapy or have CD19 negative B cell malignancies


Outcome Measures
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Primary Outcome Measures :
  1. Safety of infusion [ Time Frame: 24 weeks ]
    Treatment-related adverse events are assessed by NCI CTCAE V4.0 criteria.


Secondary Outcome Measures :
  1. Anti-tumor activity of CART [ Time Frame: 1 year ]
    Scale of CAR copies are detected by qPCR and leukemic cell burden are assessed by flow cytometry


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. Native CD19 negative B cell malignancies or relapse after CD19-CAR-T immunotherapy.
  3. Malignant B cells expressing one or more of the following surface molecules: CD22/CD123/CD38/CD10/CD20/TSLPR.
  4. The KPS score over 80 points, and survival time is more than 1 month.
  5. Greater than Hgb 80 g/L.
  6. No contraindications to blood cell collection.

Exclusion Criteria:

  1. Complications with other active diseases, and difficult to assess patient response.
  2. Bacteria, fungus, or virus infection, and unable to control.
  3. Living with HIV.
  4. Active HBV and HCV infection.
  5. Pregnant and nursing mothers.
  6. Under systemic steroid use within a week of the 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): NCT04016129


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

Locations
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China, Guangdong
Zhujiang Hospital of Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510282
Contact: Yuhua Li, M.D, Ph.D    86-13533706656    liyuhua2011gz@163.com   
Shenzhen Geno-immune Medical Institute Recruiting
Shenzhen, Guangdong, China, 518000
Contact: Lung-Ji Chang, PhD    +86-0755 8672-5195    c@szgimi.org   
China, Hebei
Zhongxi Children Hospital Recruiting
Shijiazhuang, Hebei, China, 050006
Contact: Yaochen Zhang, M.D         
Sponsors and Collaborators
Shenzhen Geno-Immune Medical Institute
Investigators
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Principal Investigator: Lung-Ji Chang, PhD Shenzhen Geno-Immune Medical Institute
More Information
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Responsible Party: Shenzhen Geno-Immune Medical Institute
ClinicalTrials.gov Identifier: NCT04016129    
Other Study ID Numbers: GIMI-IRB-19003
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019

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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:
CD19- B-ALL
CART
CD22, CD123, CD38, CD10, CD20, TSLPR
Additional relevant MeSH terms:
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Leukemia
Leukemia, B-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Leukemia, Lymphoid
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Chronic Disease
Disease Attributes
Pathologic Processes