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

• ClinicalTrials.gov Identifier: NCT04840875
• Recruitment Status: Recruiting
• First Posted: April 12, 2021
• Last Update Posted: August 15, 2022
• Sponsor: Beijing Boren Hospital
• Information provided by (Responsible Party): Beijing Boren Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
T Cell Lymphoma; T-cell Leukemia	Biological: chimeric antigen receptor T cell treatment	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I Clinical Trial of Autologous CD7-CAR T Cells in the Treatment of High-risk Acute T-cell Leukemia / Lymphoma
• Actual Study Start Date: April 20, 2021
• Estimated Primary Completion Date: April 20, 2023
• Estimated Study Completion Date: April 20, 2025

Arms and Interventions

Arm

Intervention/treatment

Experimental: chimeric antigen receptor T cell treatment

Biological: chimeric antigen receptor T cell treatment; 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.

Outcome Measures

Primary Outcome Measures :

1. DLT rate [ Time Frame: 21 days ]
   The DLT rate to the CAR-T treatment

Eligibility Criteria

• Ages Eligible for Study: up to 70 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. 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
2. 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
3. Male or female, aged 0-70 years
4. No serious allergic constitution
5. Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) score 0 to 2
6. Have life expectancy of at least 60 days based on investigator's judgement
7. CD7 positive in bone marrow or peripheral blood or immunohistochemistry
8. 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)
9. 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:

1. Intracranial hypertension or disorder of consciousness
2. Symptomatic heart failure or severe arrhythmia
3. Symptoms of severe respiratory failure
4. Complicated with other types of malignant tumors
5. Diffuse intravascular coagulation
6. Serum creatinine and / or blood urea nitrogen ≥ 1.5 times of the normal value
7. Suffering from septicemia or other uncontrollable infections
8. Patients with uncontrollable diabetes
9. Severe mental disorders
10. Obvious and active intracranial lesions were detected by cranial magnetic resonance imaging (MRI)
11. Have received organ transplantation (excluding hematopoietic stem cell transplantation);
12. Reproductive-aged female patients with positive blood HCG test
13. Screened to be positive of infection of hepatitis (including hepatitis B and C), AIDS or syphilis

Contacts and Locations

Contacts

Contact: Jing Pan; +8618911067969; panj@borenhospital.com

Locations

China, Beijing

Beijing Boren Hospital; Recruiting

Beijing, Beijing, China, 100000

Contact: Jing Pan, Master +8618911067969 panj@borenhospital.com

Sponsors and Collaborators

Beijing Boren Hospital

More Information

• Responsible Party: Beijing Boren Hospital
• ClinicalTrials.gov Identifier: NCT04840875
• Other Study ID Numbers: BRYY-IIT-LCYJ-2021-004
• First Posted: April 12, 2021
• Last Update Posted: August 15, 2022
• Last Verified: August 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Lymphoma; Leukemia; Leukemia, T-Cell; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Lymphoid; Precursor Cell Lymphoblastic Leukemia-Lymphoma