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

Acute Myeloid Leukemia Clinical Trial

Official title:

Humanized Chimeric Antigen Receptor T Cells Against CD7 for Refractory/Relapsed CD7+ Acute Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04762485
• Other study ID #: PGSDFYY 202101
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: June 1, 2021
• Est. completion date: February 28, 2024

Study information

• Verified date: January 2021
• Source: The First Affiliated Hospital of Soochow University
• Contact: xiaowen tang, Ph.D
• Phone: (0086)51267781856
• Email: xwtang1020[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Disease
• Acute Myeloid Leukemia
• Leukemia
• Mixed Phenotype Acute Leukemia
• T Lymphoblastic Leukemia/Lymphoma

Intervention

Biological:
• 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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Soochow University	Suzhou	(Select)

Sponsors (2)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University	PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events	Adverse events are evaluated with CTCAE V5.0	12 months
Secondary	Overall response rate (ORR)	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%.	2 years
Secondary	Cumulative incidence of relapse(CIR)	time from the date of achievement of a remission until the date of relapse.	2 years
Secondary	the duration of CAR T-cells in vivo	the time of CAR-T cells' persistence in blood and the copies of CAR-T cells	2 years