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Universal 4SCAR7U Targeting CD7-positive Malignancies

Primary Purpose

T-cell Acute Lymphoblastic Leukemia, T-cell Acute Lymphoblastic Lymphoma, Acute Myeloid Leukemia

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Universal CD7-specific CAR gene-engineered T cells
Sponsored by
Shenzhen Geno-Immune Medical Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for T-cell Acute Lymphoblastic Leukemia focused on measuring T-ALL, TCL, AML, NK lymphoma, Universal CAR T, CD7

Eligibility Criteria

6 Months - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age older than 6 months. Confirmed expression of CD7 and 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. Hgb≥80g/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.

Sites / Locations

  • Shenzhen Geno-immune Medical InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Universal 4SCAR7U cells to treat CD7-positive hematological malignancies

Arm Description

Outcomes

Primary Outcome Measures

Safety of infusion
Treatment-related adverse events are assessed by NCI CTCAE V4.0 criteria.

Secondary Outcome Measures

Clinical response
Objective responses (complete response (CR) + partial response (PR)) are assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.

Full Information

First Posted
August 8, 2023
Last Updated
October 10, 2023
Sponsor
Shenzhen Geno-Immune Medical Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05995028
Brief Title
Universal 4SCAR7U Targeting CD7-positive Malignancies
Official Title
Safety and Efficacy of Universal 4SCAR7U T Cell Therapy Targeting CD7-positive Hematological Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 31, 2023 (Anticipated)
Primary Completion Date
September 30, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Geno-Immune Medical Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this clinical trial is to assess the feasibility, safety and efficacy of universal CAR T cells based on 4SCAR7U design against CD7-positive hematological malignancies using CD7 specific universal CAR T cells. The study also aims to learn more about the function of CD7 targeting CAR T cells and their persistence in patients of hematological malignancies.
Detailed Description
Hematological malignancies including B-, T-cell acute lymphoblastic leukemia (B-ALL, T-ALL), B and T cell lymphoma (BCL, 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 treatment outcomes. According to European Group for the Immunological Characterization of Leukemias (EGIL), the presence of cytoplasmic or membrane expression of CD3 defines T-ALL. Several immunophenotypic classifications have been 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; and (TIV), 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 molecule that plays important role in T cell and 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 has been 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, the study proposes to investigate an universal CD7 targeting CAR-T design, 4SCAR7U in combination with alternative targeting CAR-T cells as a new strategy to treat CD7-positive hematological malignancies. The 4SCAR7U T cells are genetically engineered and manufactured in bulk amount that can be supplied off-the-shelf without being custom made from individual patients. The immediate availability of the CAR-T cells makes clinical treatment convenient and timely for rapid progressing disease or for highly immune suppressed patients. This application can be time- and cost-effective. This novel approach may also overcome problems of functionally defective autologous T cells. The purpose of this clinical trial is to assess the feasibility, safety and efficacy of the 4SCAR7U T cell product in hematological malignancies. Another goal of the study is to learn more about the function of this novel product and its persistence in the patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
T-cell Acute Lymphoblastic Leukemia, T-cell Acute Lymphoblastic Lymphoma, Acute Myeloid Leukemia, NK Cell Lymphoma
Keywords
T-ALL, TCL, AML, NK lymphoma, Universal CAR T, CD7

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Universal 4SCAR7U cells to treat CD7-positive hematological malignancies
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Universal CD7-specific CAR gene-engineered T cells
Intervention Description
Infusion of 4SCAR7U T cells
Primary Outcome Measure Information:
Title
Safety of infusion
Description
Treatment-related adverse events are assessed by NCI CTCAE V4.0 criteria.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Clinical response
Description
Objective responses (complete response (CR) + partial response (PR)) are assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age older than 6 months. Confirmed expression of CD7 and 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. Hgb≥80g/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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lung-Ji Chang, Ph.D
Phone
86-136 7112 1909
Email
c@szgimi.org
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Deng
Phone
86-0755-8672 5195
Email
c@szgimi.org
Facility Information:
Facility Name
Shenzhen Geno-immune Medical Institute
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lung-Ji Chang, Ph.D
Phone
86-0755-8672 5195
Email
c@szgimi.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Universal 4SCAR7U Targeting CD7-positive Malignancies

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