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

Phase 1

• Conditions: Acute Myeloid Leukemia; Mixed Phenotype Acute Leukemia; T Lymphoblastic Leukemia/Lymphoma
• Interventions: Biological: Humanized CD7 CAR-T cells

• Registration Number: NCT04762485
• Lead Sponsor: The First Affiliated Hospital of Soochow University

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-02-17
• Study First Posted: 2021-02-21
• Study Start: 2021-06-01
• Last Update Submitted: 2021-06-01
• Last Update Posted: 2021-06-02
• Primary Completion: 2023-02-28
• Study Completion: 2024-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CD38 positive relapsed or refractory acute leukemia	Humanized CD7 CAR-T cells	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

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events	12 months	Adverse events are evaluated with CTCAE V5.0

Secondary Outcome Measures

Name	Time	Method
the duration of CAR T-cells in vivo	2 years	the time of CAR-T cells' persistence in blood and the copies of CAR-T cells
Overall response rate (ORR)	2 years	ORR includes CR, CRi, MLFS and PR. Complete remission (CR)#Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \>1.0x 10\^9/L; platelet count \>100x10\^9/L. CR with incomplete hematologic recovery (CRi)#All CR criteria except for residual neutropenia (\<1.0x10\^9/L) or thrombocytopenia (\<100x10\^9/L). Morphologic leukemia-free state (MLFS): Bone marrow blasts \<5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. Partial remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.
Cumulative incidence of relapse(CIR)	2 years	time from the date of achievement of a remission until the date of relapse.

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, (Select), China