Humanized CD7 CAR T-cell Therapy for r/r CD7+ Acute Leukemia

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Brief Title

Humanized CD7 CAR T-cell Therapy for r/r CD7+ Acute Leukemia

Official Title

Humanized Chimeric Antigen Receptor T Cells Against CD7 for Refractory/Relapsed CD7+ Acute Leukemia

Brief Summary

      This is a prospective,open-label, single center and single arm phase 1/2 study to evaluate
      the efficacy and safety of T cells expressing humanized CD7 chimeric antigen receptors
      treatment for patients with refractory/relapsed CD7 positive acute leukemia.
    

Detailed Description

      The patients will receive infusion of CAR T-cells targeting CD7 to confirm the safety and
      efficacy of CD7 CAR T-Cells in CD7+ relapsed or refractory acute leukemia.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Number of Adverse Events

Secondary Outcome

 Overall response rate (ORR)

Condition

T Lymphoblastic Leukemia/Lymphoma

Intervention

Humanized CD7 CAR-T cells

Study Arms / Comparison Groups

 CD38 positive relapsed or refractory acute leukemia
Description:  Biological/Vaccine: Humanized CD7 CAR-T cells Split intravenous infusion of CD7 CAR-T cells [dose escalating infusion of (0.5- 10)x10^6 CD7 CAR-T cells/kg

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

20

Start Date

June 1, 2021

Completion Date

February 28, 2024

Primary Completion Date

February 28, 2023

Eligibility Criteria

        Inclusion Criteria:

          1. Diagnosed CD7 positive relapsed/refractory acute leukemia.

          2. Age 12-65 years.

          3. Eastern Cooperative Oncology Group (ECOG) score 0-2.

          4. CD7 on leukemia is >30% positive detected with flow cytometry.

          5. Patients with left ventricular ejection fraction ≥ 0.5 by echocardiography or grade
             I/II cardiovascular dysfunction according to the New York Heart Association
             Classification.

          6. Patients with aspartate aminotransferase or glutamic-pyruvic transaminase > 3x upper
             limit of normal or bilirubin > 2.0 mg/dL.

        Exclusion Criteria:

          1. Patients are pregnant or lactating

          2. Patients with congenital immunodeficiency.

          3. Patients with central nervous system leukemia.

          4. Patients with uncontrolled active infection.

          5. Patients with active hepatitis B or hepatitis C infection.

          6. Patients with HIV infection.

          7. Patients with atrial or venous thrombosis or embolism.

          8. Patients with myo-infarction or severe arrythmia in the recent 6 months.

          9. Other comorbidities that investigators considered not suitable for this study.
      

Gender

All

Ages

12 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

xiaowen tang, Ph.D, (0086)51267781856, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04762485

Organization ID

PGSDFYY 202101


Responsible Party

Sponsor

Study Sponsor

The First Affiliated Hospital of Soochow University

Collaborators

 PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Study Sponsor

xiaowen tang, Ph.D, Principal Investigator, The First Affiliated Hospital of Soochow University


Verification Date

January 2021