Trial | NCT03497533  Report issue

Title

Treatment of Refractory/Relapsed Non-Hodgkin Lymphoma With TriCAR-T_CD19
TriCAR-T-CD19 Adoptive Immunotherapy for CD19-positive Refractory/Relapsed Non-Hodgkin Lymphoma

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    6
This is a single arm, open-label, single-center, phase 1/2 study, to determine the safety and efficacy of TriCAR-T-CD19, an autologous tri-functional anti-CD19 chimeric antigen receptor (CAR)-positive T cell therapy, in refractory/Relapsed Non-Hodgkin Lymphoma (NHL).
The tri-functional anti-CD19 chimeric antigen receptor contains an anti-CD19 scFv, a PD-L1 blocker, and a cytokine complex, enabling the TriCAR-T-CD19 to simultaneously targeting the CD19 positive NHL，blocking the inhibitory PD-L1 signal and stimulating T/NK cell activation and expansion.
Study Started
Aug 03
2018
Primary Completion
Dec 31
2020
Anticipated
Study Completion
Dec 31
2020
Anticipated
Last Update
Sep 06
2019

Biological TriCAR-T-CD19

A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by a single infusion of CAR transduced autologous T cells administered intravenously at a target dose of 0.5-1 x 10^6 CAR+ T cells/kg

TriCAR-T-CD19 Experimental

Tri-functional anti-CD19 chimeric antigen receptor transduced autologous T cells will be administered intravenously

Criteria 

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;
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.
No available standard therapy;
At least one measurable lesion per revised IWG Response Criteria;
Aged 18 to 68 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 ≤grade 1;
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);
Female must be not pregnant during the study.

Exclusion Criteria:

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;
History of allogeneic stem cell transplantation;
Prior other CAR therapy or other genetically modified T cell therapy;
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;
Subjects with detectable cerebrospinal fluid malignant cells, or brain metastases, or with a history of CNS lymphoma, cerebrospinal fluid malignant cells or brain metastases;
Lactating women;
Active infection with hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive);
Subjects need systematic usage of corticosteroid;
History of any gene therapy;
Subjects need systematic usage of immunosuppressive drug;
Known history of infection with HIV;
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.
No Results Posted