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4SCAR-T Therapy Post CD19-targeted Immunotherapy

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ClinicalTrials.gov Identifier: NCT04430530
Recruitment Status : Recruiting
First Posted : June 12, 2020
Last Update Posted : June 12, 2020
Sponsor:
Collaborators:
ShiJiaZhuang Zhongxi Children Hospital
Shenzhen Children's Hospital
The Seventh Affiliated Hospital of Sun Yat-sen University
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 (4SCAR-T) targeting CD19-negative B-ALL that express alternative surface antigens such as CD22, CD10, CD20, CD38, and CD123, as many patients relapse after anti-CD19 immunotherapy. Clinical response and optiminzation 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
CD19 Negative B-cell Malignancies Biological: Infusion of 4SCAR-T specific to CD22/CD123/CD38/ CD10/CD20 Phase 1 Phase 2

Detailed Description:

Anti-CD19 immunotherapy based on antibody conjugated drugs or CD19-CAR-T cells has demonstrated unprecedented positive response in relapsing/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). However, many patients still relapse and up to 30-50% of those relapses are characterized by the loss of CD19 surface antigen. Patients with CD19-negative relapse 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, the 4th generation CAR gene-modified T cells targeting CD22, CD10, CD20, CD38, or CD123 have been considered in post anti-CD19 treatment. This study aims to evaluate safety and efficacy of administrating one or multiple non-CD19 targeting CAR-T cells to patients with CD19-escaped 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: 4SCAR-T Therapy After Anti-CD19 Immunotherapy Targeting B Cell Acute Lymphoblastic Leukemia
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arms and Interventions
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Arm Intervention/treatment
Experimental: 4SCAR-CD22/CD123/CD38/CD10/CD20 infusion
Patients who have relapsed after anti-CD19 immunotherapy or have CD19 negative B cell malignancies
 Biological: Infusion of 4SCAR-T specific to CD22/CD123/CD38/ CD10/CD20
Patients who have relapsed after anti-CD19 immunotherapy or have CD19 negative B cell malignancies


Outcome Measures
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Primary Outcome Measures :
  1. Safety of fourth generation anti-CD22/CD123/CD38/CD10/CD20 CAR-T cells [ Time Frame: 24 weeks ]
    Treatment-related adverse events are assessed by NCI CTCAE V4.0 criteria.


Secondary Outcome Measures :
  1. Anti-tumor activity of fourth generation anti-CD22/CD123/CD38/CD10/CD20 CAR-T cells [ 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. B cell malignancies relapsed after anti-CD19 immunotherapy.
  3. Malignant B cells expressing one or more of the following surface molecules: CD22/CD123/CD38/CD10/CD20.
  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. 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 use within a week of the treatment.
  7. Judged difficult to cooporate for continued evaluation.
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): NCT04430530


Contacts
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Contact: Lung-Ji Chang, phD +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   
The Seventh Affilliated Hospital, Sun Yat-Sen University Recruiting
Shenzhen, Guangdong, China, 518107
Contact: Bo Wang, MD    86-0755-23242570    wangb68377@sina.com   
China, Hebei
Shijiazhuang Zhongxi Children Hospital Recruiting
Shijiazhuang, Hebei, China
Contact: Guangming Qiao, MD    +86-13731113069      
Sponsors and Collaborators
Shenzhen Geno-Immune Medical Institute
ShiJiaZhuang Zhongxi Children Hospital
Shenzhen Children's Hospital
The Seventh Affiliated Hospital of Sun Yat-sen University
More Information
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Responsible Party: Shenzhen Geno-Immune Medical Institute
ClinicalTrials.gov Identifier: NCT04430530    
Other Study ID Numbers: GIMI-IRB-20008
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:
4S CAR-T CD22
4S CAR-T CD123
4S CAR-T CD38
 4S CAR-T CD10
4S CAR-T CD20
CD19 Negative B cell leukemiaB-ALL
Additional relevant MeSH terms:
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Neoplasms