CD19 Positive Refractory/Relapsed Non-Hodgkin Lymphoma
Conditions
Interventions
Cases:CD19-TriCAR-T intravenous injection
Sponsors
The Second Affiliated Hospital of Hainan Medical University
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. At least one measurable lesion per revised IWG Response Criteria; 6. Aged 18 to 65 years; 7. Expected survival =12 weeks; 8. Eastern cooperative oncology group (ECOG) performance status of =2; 9. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks; 10. All other treatment induced adverse events must have been resolved to =grade 1; 11. 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).
Exclusion criteria
Exclusion criteria: 1. 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; 2. Subjects with detectable cerebrospinal fluid malignant cells, or brain metastases, or with a history of CNS lymphoma, cerebrospinal fluid malignant cells or brain metastases; 3. Lactating women; 4. Active infection with hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive); 5. Known history of infection with HIV; 6. Subjects need systematic usage of corticosteroid; 7. Subjects need systematic usage of immunosuppressive drug; 8. Planed operation, history of other related disease, or any other related laboratory tests restrict patients for the study; 9. 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 ContactHaifeng Lin
The Second Affiliated Hospital of Hai'nan Medical University
Outcome results
None listed