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

Sponsor
Beijing Boren Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04840875
Collaborator
(none)
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Study Details

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
  • Biological: chimeric antigen receptor T cell treatment
Phase 1

Study Design

Study Type:
Interventional
Anticipated 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 :
Apr 20, 2021
Anticipated Primary Completion Date :
Apr 20, 2023
Anticipated Study Completion Date :
Apr 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 [21 days]

    The DLT rate to the CAR-T treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Beijing Boren Hospital Beijing Beijing China 100000

Sponsors and Collaborators

  • Beijing Boren Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Beijing Boren Hospital
ClinicalTrials.gov Identifier:
NCT04840875
Other Study ID Numbers:
  • BRYY-IIT-LCYJ-2021-004
First Posted:
Apr 12, 2021
Last Update Posted:
Aug 15, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
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:

Study Results

No Results Posted as of Aug 15, 2022