NCT03720496UnknownPhase 1
Adoptive Immunotherapy for Refractory/Relapsed Non-Hodgkin Lymphoma With CD19-TriCART Cells
Timmune Biotech Inc.1 site in 1 country6 target enrollmentStarted: November 1, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- safety （Incidence of treatment-related adverse events as assessed by CTCAE v4.03）
Study Overview
Brief Summary
This is a single arm, open-label, phase Ⅰ study, to determine the safety and efficacy of CD19-TriCAR-T, an autologous tri-functional anti- CD19 chimeric antigen receptor (CAR)-positive T cell therapy, in Refractory/ Relapsed CD19 Positive Non-Hodgkin Lymphoma (NHL).
Detailed Description
The tri-functional anti-CD19 chimeric antigen receptor contains an anti-CD19 scFv, a PD-L1 blocker, and a cytokine complex, enabling the CD19-TriCAR-T to simultaneously targeting the CD19 positive NHL cells，blocking the inhibitory PD-L1 signal and stimulating T/NK cell activation and expansion.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 69 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All subjects must personally sign and date the consent form before initiating any study specific procedures or activities;
- •All subjects must be able to comply with all the scheduled procedures in the study;
- •Histologically or cytologically confirmed CD19 positive non-Hodgkin lymphoma;
- •At least one measurable lesion per revised IWG Response Criteria;
- •Aged 18 to 69 years;
- •Expected survival ≥12 weeks;
- •Eastern cooperative oncology group (ECOG) performance status of ≤2;
- •Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks;
- •All other treatment induced adverse events must have been resolved to
- •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
- •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;
- •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;
- •Lactating women;
- •Active infection with hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive);
- •Known history of infection with HIV;
- •Subjects need systematic usage of corticosteroid;
- •Subjects need systematic usage of immunosuppressive drug;
- •Planed operation, history of other related disease, or any other related laboratory tests restrict patients for the study;
- •Other reasons the investigator think the patient may not be suitable for the study.
Outcomes
Primary Outcomes
safety （Incidence of treatment-related adverse events as assessed by CTCAE v4.03）
Time Frame: 24 months
Incidence of treatment-related adverse events as assessed by CTCAE v4.03
Secondary Outcomes
- Partial response rate [PR] （Partial response rate per the revised International Working Group (IWG) Response Criteria）(24 months)
- Duration of Response （The time from response to relapse or progression）(24 months)
- Overall Survival （The number of patient alive, with or without signs of cancer）(24 months)
- Complete response rate[CR] (Complete response rate per the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma)(24 months)
- Progression Free Survival （The time from the first day of treatment to the date on which disease progresses）(24 months)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Unknown
Phase 1
Treatment of Refractory/Relapsed Non-Hodgkin Lymphoma With TriCAR-T_CD19Non-hodgkin Lymphoma,B CellNCT03497533Timmune Biotech Inc.6
Completed
Phase 1
A Study of C-CAR039 in Subjects With Relapsed and/or Refractory B Cell Non-Hodgkin's LymphomaB Cell Non-Hodgkin's LymphomaNCT05149391Peking University3
Unknown
Phase 1
CD19-targeting CAR T Cells in Relapsed or Refractory CD19 Positive B-cell MalignanciesB-cell MalignancyB-Cell Acute Lymphoblastic LeukaemiaB-cell LymphomaNCT03559439Shanghai Tong Ren Hospital9
Recruiting
Phase 1
BCMA-CD19 cCAR T Cell Treatment of Relapsed/Refractory Systemic Lupus Erythematosus (SLE)Relapsed/Refractory, Systemic Lupus Erythematosus (SLE)NCT05474885iCell Gene Therapeutics15
Unknown
Early Phase 1
Treatment of Non-Hodgkin Lymphoma With CD19-TriCAR-T/SILK Cell TherapyNon-Hodgkin LymphomaNCT03790891Timmune Biotech Inc.12