Multi-CAR T Cell Therapy Targeting CD7-positive Malignancies

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    30
  • sponsor
    Shenzhen Geno-Immune Medical Institute
Updated on 24 January 2021
cancer
hematologic malignancy
flow cytometry
ejection fraction

Summary

The purpose of this clinical trial is to assess the feasibility, safety and efficacy of CAR T cell therapy against CD7-positive hematological malignancies using CD7 specific CAR T cells. The study also aims to learn more about the function of CD7 CAR T cells and their persistence in patients of hematological malignancies.

Description

Hematological malignancies including T-cell acute lymphoblastic leukemia (T-ALL), T cell lymphoma (TCL), natural killer cell lymphoma (NKL) and acute myeloid leukemia (AML) are aggressive diseases which may express the early T cell development molecule CD7.

T-ALL represents 15% of childhood and 25% of adult ALL, and T-ALL patients are prone to early disease relapse and suffer from poor outcomes. Several immunophenotypic classifications have been proposed. According to European Group for the Immunological Characterization of Leukemias (EGIL), the presence of cytoplasmic or membrane expression of CD3 defines T-ALL. Four subgroups are proposed: (TI) the immature subgroup or pro-T-ALL is defined by the expression of CD7 and cCD3; (TII) pre-T-ALL also expresses CD2 and/or CD5 and/or CD8; (TIII) or cortical T-ALL shows CD1a positivity; (TIV) finally, mature T-ALL is characterized by the presence of surface CD3 and CD1a negativity.

Over the past few years, T cells modified with lentiviral chimeric antigen receptor (CAR) gene have been studied in different clinical settings. CD7 is a T cell surface protein that plays important role in T cell-B cell interaction in early lymphoid development, displays membrane expression early during T cell development before TCR rearrangement, and persists through terminal stages of T cell development, and a well-known marker for T-ALL. CD7 is considered a promising target for the treatment of T-ALL, TCL, AML and NKL. In this study, we will investigate CD7 CAR-T in combination with alternative targeting CAR-T cells as a new strategy to treat hematological malignancies.

The T cells from patients or transplantation donors will be genetically modified with lentiviral CAR vector to recognize CD7 expressed on the surface of the cancer cells. The engineered T cells will be applied to patients through intravenous delivery.

The purpose of this clinical trial is to assess the feasibility, safety and efficacy of multiple CAR-T cell therapy in hematological malignancies. Another goal of the study is to learn more about the function of CAR T cells and their persistence in the patients.

Details
Condition T-cell acute lymphoblastic leukemia, Acute myeloid leukemia, Acute Myelogenous Leukemia (AML), T-cell Acute Lymphoblastic Lymphoma, NK Cell Lymphoma, T-cell Acute Lymphoblastic Lymphoma, acute myelogenous leukemia, anll, acute myeloblastic leukemia, T-cell Acute Lymphoblastic Lymphoma
Treatment CD7-specific CAR gene-engineered T cells
Clinical Study IdentifierNCT04033302
SponsorShenzhen Geno-Immune Medical Institute
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 1 yrs and 75 yrs?
Gender: Male or Female
Do you have any of these conditions: Acute myeloid leukemia or T-cell acute lymphoblastic leukemia or NK Cell Lymphoma or T-cell Acute Lymphoblastic Lymphoma?
Do you have any of these conditions: Acute myeloid leukemia or Acute Myelogenous Leukemia (AML) or NK Cell Lymphoma or anll or acute myeloblastic leukemia or T-cell Acute Lymphoblastic Ly...?
Age older than 6 months
Confirmed expression of CD7 or additional surface antigens in the cancer cells by immuno-histochemical staining or flow cytometry
Karnofsky performance status (KPS) score is higher than 80 and life expectancy > 3 months
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction 50%, oxygen saturation 90%, creatinine 2.5 upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 3 upper limit of normal, total bilirubin 2.0mg/dL
Hgb80g/L
No cell separation contraindications
Abilities to understand and the willingness to provide written informed consent

Exclusion Criteria

Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection
Active bacterial, fungal or viral infection not controlled by adequate treatment
Known HIV or hepatitis C virus (HCV) infection
Pregnant or nursing women may not participate
Use of glucocorticoid for systemic therapy within one week prior to entering the trial
Previous treatment with any gene therapy products
Patients, in the opinion of investigators, may not be able to comply with the study
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