Status:
WITHDRAWN
A Study of Anti-CD7 CAR-T Cells in Pediatric and Young Adult Patients With Relapse and Refractory T-ALL/ T-LBL
Lead Sponsor:
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Conditions:
T-cell Acute Lymphoblastic Leukemia
T-lymphoblastic Lymphoma
Eligibility:
All Genders
2-25 years
Phase:
EARLY_PHASE1
Brief Summary
T cells are a type of immune cell. Like other cells of the body, T Cells can develop cancer. T cell cancers mainly include T cell leukaemia and T cell lymphoma, both of which have a relatively poor pr...
Detailed Description
Who can participate? Patients diagnosed with relapsed/refractory T cell leukaemia or lymphoma. Both genders, aged 2-25 years old. What does the study involve? Enrolled participants are randomly chose...
Eligibility Criteria
Inclusion
- 2 to 25 years
- Diagnosed with relapsed and refractory CD7 + T cell acute lymphocytic leukemia (T-ALL) or relapsed and refractory CD7 + T lymphoblastic lymphoma (T-LBL)
- Quantifiable tumor burden
- Eastern cooperative oncology group (ECOG) performance status of 0 to 1
- Life expectancy ≥12 weeks
- Adequate organ function defined as:
- Serum ALT/AST ≤2.5 ULN
- Creatinine clearance (as estimated by Cockcroft Gault) ≥60 mL/min
- PT and APTT≤1.5 ULN
- Total bilirubin ≤1.5 ULN
- Cardiac ejection fraction ≥45%
- No clinically significant ECG findings
- Baseline oxygen saturation \>90% on room air
- Recovered from acute toxic effects of prior chemotherapy ≥one week before entering this study
- Agreement to use of medical-approved-contraception during the period of trial and in 1 year after cell transfusion therapy
- Signed informed consent form
Exclusion
- Diagnosis of other malignancy (except non-melanoma and cervical carcinoma in situ, bladder cancer, breast cancer that have a disease-free survival of more than 5 years)
- Severe mental disorders
- History of hereditary diseases, including but not limited to: Fanconi anemia, Shut-Dai syndrome, Costman syndrome or any other known bone marrow failure syndrome
- Grade 2-4 acute graft-versus-host disease (GVHD) (Glucksberg criteria) or extensive chronic GVHD (Seattle criteria)
- Grade III-IV heart failure or myocardial infarction, angioplasty or stent placement, unstable angina pectoris, or other clinically prominent heart disease within one year before enrollment
- History or presence of CNS disorder, including but not limited to: seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
- Positive for any of the following etiological tests: HIV, HBV, HCV, TPPA
- Presence of fungal, bacterial, viral, or other infection that is uncontrolled
- Severe allergies
- History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years
- History or diagnosis of pulmonary fibrosis
- Participation in other clinical trials ≤4 weeks prior to enrollment
- Concomitant disease that require systemic steroids or other immune suppressive therapy during the study period in researcher's judgement
- Patients who are contraindicated to cyclophosphamide, fludarabine
- Allogeneic cell therapy (such as donor lymphocyte infusion, DLI) ≤6 weeks prior to enrollment
- Poor adherence due to physical, family, social, geographic, and other factors, who cannot follow the research plan and follow-up plan
- Pregnant and lactating women
- Any other conditions that researcher think it is inappropriate for the subject to anticipate the trial
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04860817
Start Date
December 1 2021
End Date
November 1 2023
Last Update
November 29 2022
Active Locations (1)
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1
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Kunming, Yunnan, China, 650100 P.R.China