Status:
COMPLETED
Clinical Study of ET190L1 ARTEMIS™ in Relapsed, Refractory B Cell Lymphoma
Lead Sponsor:
Eureka Therapeutics Inc.
Collaborating Sponsors:
Peking University
Conditions:
Lymphoma, B-Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is to determine the safety, including potential dose limiting toxicities, of ET190L1 ARTEMIS™ T cells and the duration of in vivo survival of ET190L1 ARTEMIS™ T cells in patients with relas...
Detailed Description
ET190L ARTEMIS™ is a novel chimeric T-cell therapy platform that in preclinical studies, functionally matches the efficacy of CAR T cells, but dramatically reduces the release of cytokines upon killin...
Eligibility Criteria
Inclusion
- Patients with relapsed/refractory CD19+ B-cell lymphoma, with no effective therapy available per NCCN guidelines
- No HCV, HIV infection, no active HBV
- Liver and kidney function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) does not exceed five times the upper limit of normal range. ALT \<200U / L, bilirubin \<2.0 mg/ dL
- Renal function: creatinine \<2.5mg / dL; Pre-treatment absolute creatinine clearance ≥50 mL / minute
- CBC: Hemoglobin ≥ 80g / L, Absolute Neutrophil Counts ≥1 × 10\^9 / L, Platelets ≥50 × 10\^9 / L
- Echocardiography or multiple gated angiogram (MUGA) ejection fraction\> 45%
- ECOG performance status ≤2, expected survival time \> 3 months per PIs opinion
- Women of childbearing age should have a negative pregnancy test and agree to use effective contraception during treatment and 1 year after the last dose.
- Had a recurrence after at least a first-line systemic treatment
- Peripheral venous access is available and no issues with apheresis for lymphocyte isolation
- Voluntarily signed informed consent form
Exclusion
- Women in pregnancy and lactation
- Unable to perform leukapheresis and iv infusion
- With active infection
- Major organ failure
- Continuously used glucocorticoids or other immunosuppressive agents within 4 weeks
- T cell deficiency or T cells are difficult to be transduced
Key Trial Info
Start Date :
September 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03415399
Start Date
September 9 2017
End Date
December 31 2020
Last Update
March 16 2021
Active Locations (1)
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1
Peking University Cancer Hospital
Beijing, China, 100015