Status:
UNKNOWN
Treatment of Non-Hodgkin Lymphoma With CD19-TriCAR-T/SILK Cell Therapy
Lead Sponsor:
Timmune Biotech Inc.
Conditions:
Non-Hodgkin Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
EARLY_PHASE1
Brief Summary
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.
Detailed Description
CD19-TriCAR contains an anti-CD19 scFv, a PD-L1 blocker, and a cytokine complex, enabling the CD19-TriCAR-T/SILK to simultaneously targeting the CD19 positive Non-Hodgkin lymphoma，blocking the inhibit...
Eligibility Criteria
Inclusion
- 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;
- 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;
- At least one measurable lesion per revised IWG Response Criteria;
- Aged \<70 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);
Exclusion
- Presence of fungal, bacterial, viral, or other infection that is hardly to control（defined by investigator）;
- 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 or women of childbearing age who plan to conceive during the time period;
- 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 consider the patient may not be suitable for the study.
Key Trial Info
Start Date :
January 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03790891
Start Date
January 5 2019
End Date
January 1 2022
Last Update
March 13 2020
Active Locations (3)
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1
Hainan Cancer Hospital
Haikou, Hainan, China, 570100
2
Hainan General Hospital
Haikou, Hainan, China, 570100
3
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China, 570100