Clinical trial · Interventional
L218CAR19 in Patients With Relapsed/Refractory B-cell Lymphoma
A Phase 1, Open-label, Dose Escalating Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of L218CAR19 in Patients With CD19 Positive Relapsed/Refractory B-cell Lymphomas
NCT06478381CI-TRIAL-00078321unknownPhase 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)
L218CAR19 is a kind of chimeric antigen receptor T-cell immunotherapy targeting CD19 on B cells. The goal of this study is to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity of L218CAR19 in patients with B-cell lymphomas who have received at least two lines of systemic treatment.
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 |
|---|---|---|---|
| Relapsed/Refractory B-cell Lymphomas | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| L218CAR19 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose Escalation
- description
- L218CAR19 is administered via infusion with ascending dose levels to determine the maximum tolerated dose (MTD)
- interventionNames
- Drug: L218CAR19
Primary outcomes (2)
- measure
- Dose limiting toxicity (DLT)
- timeFrame
- Up to 4 weeks
- description
- Occurrence of DLTs
- measure
- Treatment-emergent adverse event (AE)
- timeFrame
- Up to 1 year
- description
- Incidence of treatment-emergent AEs
Secondary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-75 years at the time of inclusion * Written informed consent * Patients with relapsed/refractory CD19 positive B-cell lymphomas, who have received at least two lines of treatment * With measurable disease * ECOG PS 0-2 at protocol entry * Estimated life expectancy of 3 months or longer * Hemoglobin ≥ 8 g/dL (≥5 mmol/l); Platelets ≥ 75 x 10E9/L; Absolute neutrophil count ≥ 1.0 x 10E9/L; Platelets ≥ 50 x 10E9/L permitted if documented bone marrow involvement; Serum bilirubin ≤ 1.5 x upper limit of normal (ULN), or ≤3 x ULN if elevation is due to hepatic involvement by lymphoma; Serum glutamic-oxaloacetic transaminase (AST) and/or serum glutamic-pyruvic transaminase (ALT) ≤ 2.5 x ULN, or ≤ 5 x ULN if elevation is due to hepatic involvement by lymphoma; Serum creatinine ≤ 1.5 x ULNb; left ventricular ejection fraction (LVEF) ≥ 50% * Women of childbearing potential must use safe anticonception (e.g. contraceptive pills, intrauterine devices etc.) during the study and 6 months after the administration of study drug; Male patients must use contraception for the duration of the study and 6 months after the administration of study drug if his partner is of childbearing potential Exclusion Criteria: * Patients with heart disease: atrial fibrillation; History of Class III or IV New York Heart Association (NYHA) heart failure, myocardial infarction or other significant cardiac disease within 12 months of screening; LVEF\<50%; clinical significant pericardial effusion; Long QT syndrome * History of severe pulmonary function impairment * With other uncontrolled malignancy * With active bacterial, viral, or fungal infections * WIth uncontrolled autoimmune disease or congential immunodeficiency * HIV antibody positive patients * Known severe hypersensitivity to biological product * Patients with known active central nervous system (CNS) disease, including lymphoma CNS involvement * Patients with prior CAR-T therapy * History of allogeneic stem cell transplantation * History of autogeneic stem cell transplantation within 6 months of screening * History of major surgery within 4 weeks of screening * Patients receiving live (attenuated) vaccines within 6 weeks of screening * Pregnant or lactating women, or pregnant plan within 12 months * Involvement of cardiac tissue by lymphoma * with emergency due to oncothlipsis * Unwillingness or inability to comply with the protocol * Deemed 'unfit' by the treating physician
References
Publications (0)
Data not yet available
No reference posted for this study.