Phase I Clinical Trial of Autologous CD7-CAR T Cells in the Treatment of High-risk Acute T-cell Leukemia / Lymphoma
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 |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: chimeric antigen receptor T cell treatment
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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.
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Outcome Measures
Primary Outcome Measures
- DLT rate [21 days]
The DLT rate to the CAR-T treatment
Eligibility Criteria
Criteria
Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
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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
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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
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Male or female, aged 0-70 years
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No serious allergic constitution
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Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) score 0 to 2
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Have life expectancy of at least 60 days based on investigator's judgement
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CD7 positive in bone marrow or peripheral blood or immunohistochemistry
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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)
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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:
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Intracranial hypertension or disorder of consciousness
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Symptomatic heart failure or severe arrhythmia
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Symptoms of severe respiratory failure
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Complicated with other types of malignant tumors
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Diffuse intravascular coagulation
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Serum creatinine and / or blood urea nitrogen ≥ 1.5 times of the normal value
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Suffering from septicemia or other uncontrollable infections
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Patients with uncontrollable diabetes
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Severe mental disorders
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Obvious and active intracranial lesions were detected by cranial magnetic resonance imaging (MRI)
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Have received organ transplantation (excluding hematopoietic stem cell transplantation);
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Reproductive-aged female patients with positive blood HCG test
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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 | |
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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.- BRYY-IIT-LCYJ-2021-004