RecruitingPhase 1NCT06478381

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


Sponsor

Henan Cancer Hospital

Enrollment

22 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests L218CAR19, an experimental CAR-T cell therapy, in patients with B-cell lymphoma (a blood cancer) that has returned or stopped responding to at least two prior treatments, including rituximab-based therapy. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed CD19-positive B-cell lymphoma that has relapsed or is refractory after at least two prior lines of treatment - You have measurable disease on imaging - Your overall health is adequate (ECOG 0–2) with adequate organ and blood count function **You may NOT be eligible if...** - You have less than 3 months expected survival - Your blood counts or organ function are below required thresholds - You have active uncontrolled infection - You have had prior CAR-T therapy that your lymphoma no longer responds to (unless CD19 expression is confirmed) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGL218CAR19

L218CAR19 is intravenously administered at three dose levels.


Locations(1)

Affiliated Cancer Hospital of Zhengzhou University

Zhengzhou, Henan, China

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NCT06478381