Anti-CD19 CAR NK Cell Therapy for R/R Non-Hodgkin Lymphoma.
- Conditions
- NHL
- Interventions
- Biological: anti-CD19 CAR NK
- Registration Number
- NCT04639739
- Lead Sponsor
- Xinqiao Hospital of Chongqing
- Brief Summary
Although the anti-CD19 CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell hematologic malignancies. There are limitations of CAR-T cells, the consuming manufacturing time and expensive price exclude the majority of patients. therefore, we designed this trial to manifest the safety and efficacy of anti-CD19 CAR NK cell therapy in non-Hodgkin lymphoma
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 9
Not provided
Any of the following points shall be deemed as no entry into this study：
Other tumors except cured non-melanoma skin cancer, cervical cancer in situ, superficial bladder cancer, breast duct cancer in situ, or other malignant tumors with complete remission of more than 5 years)；
Severe mental disorders；
A history of genetic diseases such as Fanconi anemia, Shudder-Dale syndrome, Costman syndrome, or any other known bone marrow failure syndrome；
History of allogeneic stem cell transplantation；
Heart disease with grade III-IV heart failure [NYHA classification], myocardial infarction, angioplasty or stenting, unstable angina or other heart diseases with prominent clinical symptoms within one year before admission；
Subjects with any indwelling catheter or drainage tube (such as percutaneous nephrostomy tube, bile drainage tube or pleura/peritoneum/pericardium catheter), should be excluded. (Special central venous catheter is allowed)；
Subjects with a history of CNS lymphoma, CSF malignant cells, or brain metastasis；
Subjects with a history of CNS disease,such as epilepsy, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving CNS；
Any of the following virological ELISA results are positive: HIV antibody, HCV antibody, TPPA, HBsAg；
Active infection requiring systematic treatment within 2 weeks before single collection；
Subjects with known severe allergic reactions to cyclophosphamide or fludarabine, or diagnosed as the allergy；
History of autoimmune diseases (e.g. Crohn disease, rheumatoid arthritis, systemic lupus erythematosus) that cause end-organ damage or require systemic immunosuppressive medications or systemic disease modifying drugs in the past 2 years；
Presence of pulmonary fibrosis；
Subjects who have received other clinical trial treatment within 4 weeks before participating in this trial should be excluded. Or the signing date of informed consent is within 5 half-lives of the last application of another clinical trial (whichever is longer)；
Subjects with poor compliance due to physiological, family, social, geographical and other factors, or those unable to cooperate with the study plan or follow-up； At the discretion of the investigator, there are complications requiring systemic corticosteroid therapy (≥ 5mg / day of prednisone or equivalent dose of other corticosteroids) or other immunosuppressive drugs within 6 months after this clinical research treatment；
The lactating woman who is reluctant to stop breastfeeding；
Any other condition considered unsuitable by the investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description anti-CD19 CAR NK cells anti-CD19 CAR NK The study will employ dose level cohorts of three patients that will be treated at each level described below, based on the number of T cells to be infused using the "3 + 3" dose-escalation strategy to find MTD followed by a dose-expansion phase at determined optimal dosage.
- Primary Outcome Measures
Name Time Method Incidence of dose limiting toxicity (DLTs) within 4 weeks after infusion To characterize the safety, tolerability, and determine the recommended dosage of Anti-CD19 CAR NK Cell Therapy for R/R Non-Hodgkin Lymphoma
Incidence and severity of AEs and SAEs Up to 24 months To characterize the safety, tolerability, and determine the recommended dosage of Anti-CD19 CAR NK Cell Therapy for R/R Non-Hodgkin Lymphoma
- Secondary Outcome Measures
Name Time Method The overall response rate(ORR) 1 and 3 months after infusion to characterize the efficacy of Anti-CD19 CAR NK Cell Therapy for R/R Non-Hodgkin Lymphoma
progression-free survival (PFS) 1, 3, 6, 12 and 24 months after infusion to characterize the efficacy of Anti-CD19 CAR NK Cell Therapy for R/R Non-Hodgkin Lymphoma
overall survival(OS) 1, 3, 6, 12 and 24 months after infusion to characterize the efficacy of Anti-CD19 CAR NK Cell Therapy for R/R Non-Hodgkin Lymphoma
Trial Locations
- Locations (1)
Department of Hematology, Xinqiao Hospital
🇨🇳ChongQing, Chongqing, China