L218CAR19 treatment for patients with relapsed 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
This study is testing a new treatment called L218CAR19 for people with relapsed B-cell lymphoma to see if it can help them after they haven't responded to other therapies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Henan Cancer Hospital Government |
| Drugs / interventions | CAR-T, chimeric antigen receptor, immunotherapy |
| Locations | 1 site (Zhengzhou, Henan) |
| Trial ID | NCT06478381 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates L218CAR19, a chimeric antigen receptor T-cell immunotherapy designed to target CD19 on B cells in patients with relapsed or refractory B-cell lymphomas. The study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of this treatment in individuals who have undergone at least two prior lines of systemic therapy. Participants must have measurable disease and meet specific health criteria to be eligible for the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with relapsed or refractory CD19 positive B-cell lymphomas who have received at least two lines of treatment.
Not a fit: Patients with non-CD19 positive B-cell lymphomas or those who have not received prior systemic treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat B-cell lymphomas.
How similar studies have performed: Other studies utilizing CAR T-cell therapies targeting CD19 have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Zhengzhou, Henan
- Affiliated Cancer Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
Study contacts
- Principal investigator: Yanyan Liu — Affiliated Cancer Hospital of Zhengzhou University
- Study coordinator: Yanyan Liu
- Email: yyliu@zzu.edu.cn
- Phone: 86 037165587791
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.