CD19-positive Refractory/Relapsed non-Hodgkin lymphoma
Conditions
Interventions
Case series:TriCAR-T-CD19 cell infusion
Sponsors
Hunan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. All subjects must personally sign and date the consent form before initiating any study specific procedures or activities; 2. All subjects must be able to comply with all the scheduled procedures in the study; 3. Histologically or cytologically confirmed CD19 positive non-Hodgkin lymphoma; 4. Chemotherapy-refractory disease, defined as one or more of the following: Relapsed in 6 months after most recent therapy; Progressive disease in the standard R-CHOP or CHOP chemotherapy; Disease progression or relapsed in =12 months of ASCT (must have biopsy proven recurrence in relapsed subjects); If salvage therapy is given post-ASCT, the subject must have had no response to or relapsed after the last line of therapy. 5. No available standard therapy; 6. At least one measurable lesion per revised IWG Response Criteria; 7. Aged 18 to 65 years; 8. Expected survival =12 weeks; 9. Eastern cooperative oncology group (ECOG) performance status of 0 or 1; 10. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks; 11. All other treatment induced adverse events must have been resolved to =grade 1; 12. Laboratory tests must fulfill the following criteria: ANC = 1000/uL, HGB >70g/L, Platelet count = 50,000/uL, Creatinine clearance =1.5 ULN, Serum ALT/AST =2.5 ULN, Total bilirubin =1.5 ULN (except in subjects with Gilbert's syndrome); 13. Female must be not pregnant during the study.
Exclusion criteria
Exclusion criteria: 1. History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3 years; 2. History of allogeneic stem cell transplantation; 3. Prior other CAR therapy or other genetically modified T cell therapy; 4. Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment; 5. Subjects with detectable cerebrospinal fluid malignant cells, or brain metastases, or with a history of CNS lymphoma, cerebrospinal fluid malignant cells or brain metastases; 6. Lactating women; 7. Active infection with hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive); 8. Subjects need systematic usage of corticosteroid; 9. History of any gene therapy; 10. Subjects need systematic usage of immunosuppressive drug; 11. Known history of infection with HIV; 12. Planed operation, history of other related disease, or any other related laboratory tests restrict patients for the study; 13. Other reasons the investigator think the patient may not be suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy; | — |
Countries
China
Contacts
Public ContactMing Zhou
Hunan Provincial People's Hospital
Outcome results
None listed