Clinical trial · Interventional
Treatment of Non-Hodgkin Lymphoma With CD19-TriCAR-T/SILK Cell Therapy
Adoptive Immunotherapy for Non-Hodgkin Lymphoma With CD19-TriCAR-T/SILK Cell
NCT03790891CI-TRIAL-00044003unknownEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single arm, open-label, early phase Ⅰ study, to determine the safety and efficacy of CD19-TriCAR-T and CD19-TriCAR-SILK cell therapy in Non-Hodgkin lymphoma treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD19-TriCAR-T/SILK | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CD19-TriCAR-T/SILK
- description
- CD19-TriCAR-T/SILK cells will be administered intravenously
- interventionNames
- Biological: CD19-TriCAR-T/SILK
Primary outcomes (1)
- measure
- safety (Incidence of treatment-related adverse events as assessed by CTCAE v4.03)
- timeFrame
- 24 months
- description
- Incidence of treatment-related adverse events as assessed by CTCAE v4.03
Secondary outcomes (5)
- measure
- Complete response rate[CR] (Complete response rate per the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma)
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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. Refractory or relapsed malignant Non-Hodgkin lymphoma, defined as one or more of the following: Relapsed in 6 months after most recent therapy; Progressive disease in standard chemotherapy; Disease progression or relapsed in ≤12 months of ASCT; 4. At least one measurable lesion per revised IWG Response Criteria; 5. Aged \<70 years; 6. Expected survival ≥12 weeks; Eastern cooperative oncology group (ECOG) performance status of≤2; 7. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks; 8. All other treatment induced adverse events must have been resolved to ≤grade 1; 9. 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: 1. Presence of fungal, bacterial, viral, or other infection that is hardly to control(defined by investigator); 2. Patients with symptomatic central nervous system metastasis, intracranial metastasis, and cancer cells found in cerebrospinal fluid are not recommended to participate in this study. Symptom free or post-treatment stable disease or disappearance of lesions should not be excluded. The specific selection is ultimately determined by the investigator; 3. Lactating women or women of childbearing age who plan to conceive during the time period; 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 consider the patient may not be suitable for the study.
References
Publications (3)
- BACKGROUNDLocke FL, Neelapu SS, Bartlett NL, Siddiqi T, Chavez JC, Hosing CM, Ghobadi A, Budde LE, Bot A, Rossi JM, Jiang Y, Xue AX, Elias M, Aycock J, Wiezorek J, Go WY. Phase 1 Results of ZUMA-1: A Multicenter Study of KTE-C19 Anti-CD19 CAR T Cell Therapy in Refractory Aggressive Lymphoma. Mol Ther. 2017 Jan 4;25(1):285-295. doi: 10.1016/j.ymthe.2016.10.020. Epub 2017 Jan 4. PMID 28129122
- BACKGROUNDNeelapu SS, Tummala S, Kebriaei P, Wierda W, Gutierrez C, Locke FL, Komanduri KV, Lin Y, Jain N, Daver N, Westin J, Gulbis AM, Loghin ME, de Groot JF, Adkins S, Davis SE, Rezvani K, Hwu P, Shpall EJ. Chimeric antigen receptor T-cell therapy - assessment and management of toxicities. Nat Rev Clin Oncol. 2018 Jan;15(1):47-62. doi: 10.1038/nrclinonc.2017.148. Epub 2017 Sep 19. PMID 28925994
- BACKGROUNDPorter D, Frey N, Wood PA, Weng Y, Grupp SA. Grading of cytokine release syndrome associated with the CAR T cell therapy tisagenlecleucel. J Hematol Oncol. 2018 Mar 2;11(1):35. doi: 10.1186/s13045-018-0571-y. PMID 29499750