Phase I Clinical Trial of Autologous CD7-CAR T Cell Therapy for High-risk Acute T-cell Leukemia/lymphoma

NCT04840875 | Completed Phase 1

• 1 other identifier: BRYY-IIT-LCYJ-2021-004
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

T Cell Lymphoma; T-cell Leukemia

Outcome Measures

Primary Outcomes (1)

• DLT rate

  The DLT rate to the CAR-T treatment

  21 days

Study Arms (1)

chimeric antigen receptor T cell treatment

EXPERIMENTAL

Biological: chimeric antigen receptor T cell treatment

Interventions

chimeric antigen receptor T cell treatment BIOLOGICAL

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.

chimeric antigen receptor T cell treatment

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Obvious and active intracranial lesions were detected by cranial magnetic resonance imaging (MRI)
• Have received organ transplantation (excluding hematopoietic stem cell transplantation);
• Reproductive-aged female patients with positive blood HCG test
• Screened to be positive of infection of hepatitis (including hepatitis B and C), AIDS or syphilis

Sponsors & Collaborators

• Beijing Boren Hospital: lead

Study Sites (1)

Beijing Boren Hospital

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Lymphoma, T-Cell; Leukemia, T-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Lymphoid; Leukemia; Hematologic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 12, 2021
• Study Start: September 14, 2021
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: November 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)