Multi-CAR T Cell Therapy Targeting CD7-positive Malignancies

NCT04033302 | Unknown Phase 1

• 1 other identifier: GIMI-IRB-19005
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

T-cell Acute Lymphoblastic Leukemia; T-cell Acute Lymphoblastic Lymphoma; Acute Myeloid Leukemia; NK Cell Lymphoma

Keywords

T-ALL; TCL; AML; NK lymphoma; CAR T; CD7

Outcome Measures

Primary Outcomes (1)

• Safety of infusion

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

  a year

Secondary Outcomes (1)

• Clinical response

  a year

Study Arms (1)

Single arm

EXPERIMENTAL

Multiple CAR T cells to treat CD7-positive hematological malignancies

Biological: CD7-specific CAR gene-engineered T cells

Interventions

CD7-specific CAR gene-engineered T cells BIOLOGICAL

Infusion of CD7-specific CAR-T cells

Single arm

Eligibility Criteria

• Age: 6 Months - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Hgb≥80g/L.
• No cell separation contraindications.
• Abilities to understand and the willingness to provide written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen Geno-Immune Medical Institute: lead

Study Sites (1)

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, 518000, China

RECRUITING

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid

Central Study Contacts

Lung-Ji Chang, Ph.D

CONTACT

86-0755-86725195; c@szgimi.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: July 26, 2019
• Study Start: September 1, 2019
• Primary Completion: July 31, 2021
• Study Completion: December 31, 2023
• Last Updated: September 19, 2019

Record last verified: 2019-09

Locations

CN (1)