Phase I Clinical Trial of Autologous CD7-CAR T Cells in the Treatment of High-risk Acute T-cell Leukemia / Lymphoma

Beijing Boren Hospital1 site in 1 country16 target enrollmentSeptember 14, 2021

ConditionsT Cell Lymphoma T-cell Leukemia

Interventionschimeric antigen receptor T cell treatment

Drugschimeric antigen receptor T cell treatment

Overview

Phase: Phase 1
Intervention: chimeric antigen receptor T cell treatment
Conditions: T Cell Lymphoma
Sponsor: Beijing Boren Hospital
Enrollment: 16
Locations: 1
Primary Endpoint: DLT rate
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase 1 clinical trial of autologous CD7-CAR T cells in the treatment of high-risk acute T-cell leukemia / lymphoma. Twenty subjects will be enrolled. Subjects will be pretreated with chemotherapy prior to infusion of CAR T cells: about 3 days before cells transfusion, the patients who planned to reinfuse CAR T cells were treated with fluorodarabine 30 mg/m2( body surface area) and cyclophosphamide 250 mg/m2( body surface area) for 3 days. Then this study will be using a 3+3 dose escalation approach from dose 1 (DL-1): 5×105 (±20%) to dose 2 (dl-2): 1×106 (±20%). Below the lowest dose was reinfused at the PI's discretion.

Registry

clinicaltrials.gov

Start Date

September 14, 2021

End Date

September 1, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Beijing Boren Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•In order to be eligible to participate in this study, an individual must meet all of the following criteria:
•Diagnosed as a high-risk acute T-cell leukemia / lymphoma patient with complete remission within 3 months and persistent positive of minimal residual disease, expressing tumor surface antigen CD7
•Refractory or relapsed T-cell acute lymphoblastic leukemia/lymphoma patients with no blasts in peripheral blood by flow cytometry and suspending anti-neoplastic treatment for more than 2 weeks
•Male or female, aged 0-70 years
•No serious allergic constitution
•Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) score 0 to 2
•Have life expectancy of at least 60 days based on investigator's judgement
•CD7 positive in bone marrow or peripheral blood or immunohistochemistry
•Candidates aged 8-70 years need to be sufficiently conscious and able to sign the treatment consent form and voluntary consent form. And Pediatric patients under 8 years old could be recruited after signing an informed consent form by a legal surrogate (Guardian)
•Minimal residual disease was positive after chemotherapy and there were contraindications of allogeneic hematopoietic stem cell transplantation.

Exclusion Criteria

•An individual who meets any of the following criteria will be excluded from participation in this study:
•Intracranial hypertension or disorder of consciousness
•Symptomatic heart failure or severe arrhythmia
•Symptoms of severe respiratory failure
•Complicated with other types of malignant tumors
•Diffuse intravascular coagulation
•Serum creatinine and / or blood urea nitrogen ≥ 1.5 times of the normal value
•Suffering from septicemia or other uncontrollable infections
•Patients with uncontrollable diabetes
•Severe mental disorders