Status:
COMPLETED
Multi-centers, Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of Donor-Derived CD7 CAR T Cells in Subjects With Relapsed or Refractory T-cell Leukemia/Lymphoma
Lead Sponsor:
Beijing Boren Hospital
Conditions:
T-cell Leukemia/Lymphoma
Refractory T Lymphoblastic Leukemia/Lymphoma
Eligibility:
All Genders
1-70 years
Phase:
PHASE2
Brief Summary
This is a multi-centers, single-arm, open label, Phase 2 clinical trial to evaluate the efficacy and safety of CD7 CAR T cells in subjects with relapsed or refractory T-cell leukemia/lymphoma. Seventy...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Candidates with relapse or refractory CD7+ T cell acute lymphoblastic leukemia/lymphoma, who have progressed on after treatment with all standard therapies or intolerant of standard care, have limited prognosis with currently available therapies and had no available curative treatment options (such as SCT or chemotherapy)
- Male or female, aged 1-70 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 cerebrospinal fluid (CSF) by flow cytometry, or CD7 positive in tumor tissues by immunohistochemistry; (CD7 positive criteria: Flow cytometry: Positive: \> 80% of tumor cells expressed CD7 and the mean fluorescence (MFI) of CD7 is the same as that in normal T cells; Dim: \> 80% of tumor cells expressed CD7, but the MFI of CD7 is lower than that in normal T cells as least as 1log; Partial positive: 20-80% of tumor cells expressed CD7 and the MFI of CD7 is the same as that in normal T cells. tumor tissue immunohistochemistry: Positive \> 30% tumor cells expressed CD7);
- Provide a signed informed consent before any screening procedure; subjects who voluntarily participate in the study should have the ability to understand and sign the informed consent form and be willing to follow the study visit schedule and relevant study procedure, as specified in the protocol. Candidates aged 19-70 years need to be sufficiently conscious and able to sign the treatment consent form and voluntary consent form; Children candidates of 1-7 can be recruited after the legal guardian or patient advocate has signed the treatment consent form and voluntary consent form. Children candidates of 8-18 years old need to be sufficiently conscious and able to sign the treatment consent form and voluntary consent form and their legal guardian or patient advocate has also need to sign the treatment consent form and voluntary consent form, respectively
- Exclusion criteria:
- 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 bone marrow transplant)
- Reproductive-aged female patients with positive blood human chorionic gonadotropin (HCG) test
- Screened to be positive of infection of hepatitis (including hepatitis B and C), acquired immunodeficiency syndrome (AIDS) or syphilis
Exclusion
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2024
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04689659
Start Date
December 1 2021
End Date
April 3 2024
Last Update
May 18 2025
Active Locations (1)
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1
Beijing Boren Hospital
Beijing, Beijing Municipality, China, 100000