Status:
RECRUITING
Universal 4SCAR7U Targeting CD7-positive Malignancies
Lead Sponsor:
Shenzhen Geno-Immune Medical Institute
Conditions:
T-cell Acute Lymphoblastic Leukemia
T-cell Acute Lymphoblastic Lymphoma
Eligibility:
All Genders
6-75 years
Phase:
PHASE1
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...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05995028
Start Date
October 31 2023
End Date
December 31 2026
Last Update
October 12 2023
Active Locations (1)
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1
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, China, 518000