Status:
COMPLETED
Phase I Clinical Trial of Autologous CD7-CAR T Cell Therapy for High-risk Acute T-cell Leukemia/lymphoma
Lead Sponsor:
Beijing Boren Hospital
Conditions:
T Cell Lymphoma
T-cell Leukemia
Eligibility:
All Genders
Up to 70 years
Phase:
PHASE1
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 chemot...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2023
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04840875
Start Date
September 14 2021
End Date
September 1 2023
Last Update
November 14 2024
Active Locations (1)
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1
Beijing Boren Hospital
Beijing, Beijing Municipality, China, 100000