NCT07006012

RGL-305+ Lymphoma + Exploratory Clinical Study

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study adopted a "3+3" dose escalation design. RGL-305 preset two dose groups: low dose and high dose , and each dose group planned to enroll 3 to 6 subjects. The first patient in each group was set as a sentinel subject and observed for at least 48 hours. After evaluation by the investigators, it was found that no important adverse reactions occurred (such as CRS ≥ grade 3, aGVHD, anaphylaxis, etc.), and the other subjects at this dose level could be administered. The DLT observation period was set to 21 days after the subject received RGL-305 for the first time, during which the subject continued to receive the same dose level of RGL-305 for 1 cycle every 2 weeks (Q2W) and the first day of each cycle (D1), receiving a total of up to 5 cycles of cell transfusion. Treatment until the end of the cycle, disease recurrence or disease progression, intolerable toxicity, initiation of a new anti-tumor therapy, death (whichever occurs first)

Conditions

• Lymphoma Patients With Complete Response (CR) or Partial Response (PR) After Standard Treatment Had a Positive Minimal Residual Lesion (MRD)

Interventions

Type	Name	Description
DRUG	RGL-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.

Timeline

• Start date: 2025-04-21
• Primary completion: 2028-03-31
• Completion: 2031-12-31
• First posted: 2025-06-05
• Last updated: 2026-03-24

Locations

1 site across 1 country: China