Clinical trial · Interventional
Clinical Study of ET190L1 ARTEMIS™ in Relapsed, Refractory B Cell Lymphoma
Phase 1, Open-label, Single-arm, Dose-escalation Clinical Study Evaluating the Safety and Efficacy of ET190L1 ARTEMIS™ (Anti-CD19-ARTEMIS™) in Relapsed, Refractory B Cell Lymphoma
- 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)
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 relasped/refractory B-cell lymphoma. For patients with detectable disease, the study will also measure anti-tumor responses after ET190L1 ARTEMIS™ cell infusions.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, B-Cell | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ET190L1 ARTEMIS™ T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- i.v. arm
- description
- ET190L1 ARTEMIS™ T cells administered by intravenous (IV) infusion
- interventionNames
- Biological: ET190L1 ARTEMIS™ T cells
Primary outcomes (6)
- measure
- Maximum Tolerated Dose
- timeFrame
- 28 days up to 24 months
- description
- Determine the safety, including potential dose limiting toxicities, of the ET190L1 ARTEMIS™ T cells. A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the ET190L1 ARTEMIS™ T-cells, which is irreversible or life threatening or CTCAE Grade 3-5. Assessed at all visits.
- measure
- Toxicity profile of ET190L1 ARTEMIS™ T-cell treatment
- timeFrame
- 28 days up to 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available