Clinical trial · Interventional
ET190L1-ARTEMIS™ T Cells in Relapsed, Refractory B Cell Leukemia and Lymphoma
Phase 1, Open-label, Single-arm, Dose-escalation Clinical Study Evaluating the Safety and Efficacy of ET190L1-ARTEMIS™2 in Relapsed, Refractory B Cell Leukemia and Lymphoma
NCT03895944CI-TRIAL-00037867unknownEarly 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)
Clinical study to evaluate safety and pharmacokinetics (primary objectives) and efficacy (secondary objective) of ET190L1-ARTEMIS™2 T-cells in patients with Cluster of Differentiation (CD) 19+ B cell Leukemia and Lymphoma
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CD19+ Leukemia, B-Cell | — | UNRESOLVED | — |
| CD19+ Lymphoma, B-Cell | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ET190L1-ARTEMIS™ T cells - iv high dose | Biological | — | UNRESOLVED |
| ET190L1-ARTEMIS™ T cells -iv low dose | Biological | — | UNRESOLVED |
| ET190L1-ARTEMIS™ T cells -iv middle dose | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- iv low dose
- description
- Autologous ET190L1-ARTEMIS™ T cells administered by intravenous (IV) infusion with low dose (1x10\^6) in Leukemia or Lymphoma patients
- interventionNames
- Biological: ET190L1-ARTEMIS™ T cells -iv low dose
- type
- EXPERIMENTAL
- label
- iv middle dose
- description
- Autologous ET190L1-ARTEMIS™ T cells administered by intravenous (IV) infusion with middle dose (3x10\^6) in Leukemia or Lymphoma patients
- interventionNames
- Biological: ET190L1-ARTEMIS™ T cells -iv middle dose
- type
- EXPERIMENTAL
- label
- iv high dose
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with relapsed/refractory CD19+ B-cell lymphoma or Leukemia, with no effective therapy available per National Comprehensive Cancer Network (NCCN) guidelines * Eastern Cooperative Oncology Group (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. * Peripheral venous access is available and no issues with apheresis for lymphocyte isolation * serum alanine aminotransferase(ALT)\<200 Unit/L, ALT/Aspartate aminotransferase(AST)\<3 normal range; serum creatinine (Cr)\<2.5mg/dL * Voluntarily signed informed consent form Exclusion Criteria: * Women in pregnancy and lactation * Unable to perform leukapheresis and iv infusion * With active infection * Major organ failure * Patients with dependence on corticosteroids * Continuously used glucocorticoids or other immunosuppressive agents within 2 weeks * T cell deficiency or T cells are difficult to be transduced * Patients currently receiving other investigational treatments (biotherapy, chemotherapy, or radiotherapy)
References
Publications (0)
Data not yet available
No reference posted for this study.