Humanized CD7 CAR T-cell Therapy for r/r CD7+ Acute Leukemia

Soochow University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Mixed Phenotype Acute Leukemia; T Lymphoblastic Leukemia/Lymphoma; Acute Myeloid Leukemia

Treatments: Biological: Humanized CD7 CAR-T cells

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04762485

PGSDFYY 202101

Details and patient eligibility

About

This is a prospective,open-label, single center and single arm phase 1/2 study to evaluate the efficacy and safety of T cells expressing humanized CD7 chimeric antigen receptors treatment for patients with refractory/relapsed CD7 positive acute leukemia.

Full description

The patients will receive infusion of CAR T-cells targeting CD7 to confirm the safety and efficacy of CD7 CAR T-Cells in CD7+ relapsed or refractory acute leukemia.

Enrollment: 20 estimated patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosed CD7 positive relapsed/refractory acute leukemia.
2. Age 12-65 years.
3. Eastern Cooperative Oncology Group (ECOG) score 0-2.
4. CD7 on leukemia is >30% positive detected with flow cytometry.
5. Patients with left ventricular ejection fraction ≥ 0.5 by echocardiography or grade I/II cardiovascular dysfunction according to the New York Heart Association Classification.
6. Patients with aspartate aminotransferase or glutamic-pyruvic transaminase > 3x upper limit of normal or bilirubin > 2.0 mg/dL.

Exclusion criteria

1. Patients are pregnant or lactating
2. Patients with congenital immunodeficiency.
3. Patients with central nervous system leukemia.
4. Patients with uncontrolled active infection.
5. Patients with active hepatitis B or hepatitis C infection.
6. Patients with HIV infection.
7. Patients with atrial or venous thrombosis or embolism.
8. Patients with myo-infarction or severe arrythmia in the recent 6 months.
9. Other comorbidities that investigators considered not suitable for this study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

CD38 positive relapsed or refractory acute leukemia

Experimental group

Description:

Biological/Vaccine: Humanized CD7 CAR-T cells Split intravenous infusion of CD7 CAR-T cells \[dose escalating infusion of (0.5- 10)x10\^6 CD7 CAR-T cells/kg

Treatment:

Biological: Humanized CD7 CAR-T cells