A Study of Anti-CD7 CAR-T Cells in Pediatric and Young Adult Patients With Relapse and Refractory… (NCT04860817) | Clinical Trial Compass
WithdrawnEarly Phase 1
A Study of Anti-CD7 CAR-T Cells in Pediatric and Young Adult Patients With Relapse and Refractory T-ALL/ T-LBL
Stopped: No proper participant is found.
China0Started 2021-12-01
Plain-language 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 prognosis. Currently, patients with relapsed/refractory type (the name given to cancer that reappears or grows again after a period of no changes or signs of cancer) of this leukaemia or lymphoma have limited choices for treatment. CAR-T cells are immune cells that are engineered to target specific cell markers. For example, CAR-T cells targeting the marker CD19 have shown great effectiveness in the treatment of B cell tumors that carry this marker. Here investigators construct a new universal CAR-T design targeting CD7 which is found on the cells of relapsed/refractory type T cell leukaemia and lymphoma and hope to test its safety and efficiency in the treatment of relapsed/refractory type T cell leukaemia and lymphoma.
Who can participate
Age range2 Years – 25 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
Number of patients with dose-limiting toxicity
Timeframe: up to 4 weeks after target CD7 CAR-T cells infusion
Trial details
NCT IDNCT04860817
Sponsor920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
. 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 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