T-cell Acute Lymphoblastic Leukemia Clinical Trial
Official title:
Investigating the Safety and Efficacy of Anti-CD7 CAR-T Cell Immunotherapy in Patients With Relapse and Refractory T-cell Acute Lymphoblastic Leukemia or T Lymphoblastic Lymphoma
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 1, 2023 |
Est. primary completion date | April 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 25 Years |
Eligibility | Inclusion Criteria: 1. 2 to 25 years 2. Diagnosed with relapsed and refractory CD7 + T cell acute lymphocytic leukemia (T-ALL) or relapsed and refractory CD7 + T lymphoblastic lymphoma (T-LBL) 3. Quantifiable tumor burden 4. Eastern cooperative oncology group (ECOG) performance status of 0 to 1 5. Life expectancy =12 weeks 6. Adequate organ function defined as: 1. Serum ALT/AST =2.5 ULN 2. Creatinine clearance (as estimated by Cockcroft Gault) =60 mL/min 3. PT and APTT=1.5 ULN 4. Total bilirubin =1.5 ULN 5. Cardiac ejection fraction =45% 6. No clinically significant ECG findings 7. Baseline oxygen saturation >90% on room air 7. Recovered from acute toxic effects of prior chemotherapy =one week before entering this study 8. Agreement to use of medical-approved-contraception during the period of trial and in 1 year after cell transfusion therapy 9. Signed informed consent form Exclusion Criteria: 1. 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) 2. Severe mental disorders 3. History of hereditary diseases, including but not limited to: Fanconi anemia, Shut-Dai syndrome, Costman syndrome or any other known bone marrow failure syndrome 4. Grade 2-4 acute graft-versus-host disease (GVHD) (Glucksberg criteria) or extensive chronic GVHD (Seattle criteria) 5. 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 6. 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 7. Positive for any of the following etiological tests: HIV, HBV, HCV, TPPA 8. Presence of fungal, bacterial, viral, or other infection that is uncontrolled 9. Severe allergies 10. History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years 11. History or diagnosis of pulmonary fibrosis 12. Participation in other clinical trials =4 weeks prior to enrollment 13. Concomitant disease that require systemic steroids or other immune suppressive therapy during the study period in researcher's judgement 14. Patients who are contraindicated to cyclophosphamide, fludarabine 15. Allogeneic cell therapy (such as donor lymphocyte infusion, DLI) =6 weeks prior to enrollment 16. Poor adherence due to physical, family, social, geographic, and other factors, who cannot follow the research plan and follow-up plan 17. Pregnant and lactating women 18. Any other conditions that researcher think it is inappropriate for the subject to anticipate the trial |
Country | Name | City | State |
---|---|---|---|
China | 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China | Kunming | Yunnan |
Lead Sponsor | Collaborator |
---|---|
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients with dose-limiting toxicity | Dose-limiting toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE v5.0) at 4 weeks following target CD7 CAR-T cells infusion | up to 4 weeks after target CD7 CAR-T cells infusion | |
Secondary | Overall response rate (ORR) | ORR of patients, determined by National Comprehensive Cancer Network (NCCN) clinical practice guidelines in oncology: Acute Lymphoblastic Leukemia (2016.V2) for T-ALL response rate and Lugano 2014 for T-LBL response rate. | 4 weeks, 12 weeks, 24 weeks after target CD7 CAR-T cells infusion | |
Secondary | Progression-free survival (PFS) | PFS determined from patient notes at 24 weeks following target CD7 CAR-T cells infusion. | 24 weeks after target CD7 CAR-T cells infusion | |
Secondary | Overall survival (OS) | OS determined from patient notes at 24 weeks. | 24 weeks after target CD7 CAR-T cells infusion | |
Secondary | Duration of remission (DOR) | DOR determined from patient notes at 24 weeks. | 24 weeks after target CD7 CAR-T cells infusion |
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