ClinicalTrialsFinder
RecruitingPhase 1NCT05995028

Universal 4SCAR7U Targeting CD7-positive Malignancies

Safety and Efficacy of Universal 4SCAR7U T Cell Therapy Targeting CD7-positive Hematological Malignancies

Sponsor

Shenzhen Geno-Immune Medical Institute

Enrollment

30 participants

Start Date

Oct 31, 2023

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid LeukemiaNK-Cell LymphomaT-cell Acute Lymphoblastic LeukemiaT-cell Acute Lymphoblastic Lymphoma

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.

Eligibility

Min Age: 6 MonthsMax Age: 75 Years

Inclusion Criteria7

  • 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 Criteria7

  • 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.

Interventions

BIOLOGICALUniversal CD7-specific CAR gene-engineered T cells

Infusion of 4SCAR7U T cells

Locations(1)

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05995028

Related Trials

MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)

NCT05564390331 locations

Testing the Effects of Novel Therapeutics for Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)

NCT05554406216 locations

Comparing New Treatments for People With Newly Diagnosed Acute Myeloid Leukemia That Has an IDH2 Gene Change (A MyeloMATCH Treatment Trial)

NCT06672146112 locations

Testing the Combination of an Anti-Cancer Drug, Iadademstat, With Other Anti-Cancer Drugs (Venetoclax and Azacitidine) for Treating AML

NCT065142614 locations

Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)

NCT05554393175 locations