RecruitingNot ApplicableNCT07006012

RGL-305+ Lymphoma + Exploratory Clinical Study

An Exploratory Clinical Study to Evaluate the Safety and Cytodynamic Characteristics of RGL-305 in Patients With Lymphoma


Sponsor

Fudan University

Enrollment

12 participants

Start Date

Apr 21, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is an open, prospective, dose-increasing exploratory clinical trial. To evaluate the safety, cytodynamics and initial efficacy of RGL-305 in patients with lymphoma. All enrolled lymphoma patients were required to achieve CR or PR and MRD positive after standard treatment, PR patients were required to have a Deauville score of 4, and all patients would receive RGL-305 cell reinfusion therapy.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an experimental drug called RGL-305 in patients with lymphoma who have responded to previous treatment but still have trace amounts of cancer detectable by sensitive tests (called MRD-positive). The goal is to see if RGL-305 can eliminate that remaining cancer. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with lymphoma confirmed by biopsy - You have received at least one prior standard treatment and had a complete or partial response, but still have detectable cancer by MRD testing - Your overall health is good (ECOG 0–1) - Your expected survival is at least 3 months - Your blood counts, liver, and heart function meet required levels **You may NOT be eligible if...** - You have not had prior lymphoma treatment - You have active, uncontrolled infection - You are pregnant or breastfeeding - Your organ function does not meet required thresholds 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

DRUGRGL-305

RGL-305 is administered intravenously with a recommended rate of 3-5 mL /min. The interval after the first administration was 3 weeks, and then every 2 weeks was a cycle, each cycle was given d1, and up to 5 cycles of cell transfusion were received.


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT07006012