Actively Recruiting
RGL-305+ Lymphoma + Exploratory Clinical Study
Led by Fudan University · Updated on 2026-03-24
12
Participants Needed
1
Research Sites
349 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
RGL-305+ Lymphoma + Exploratory Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Age between 18 and 75 years
- Pathologically confirmed lymphoma with at least one prior standard treatment
- Achieved complete or partial response after last treatment with positive minimal residual disease
- Partial response patients must have a Deauville score of 4
- Willing to provide blood or tissue samples for testing before and after treatment
- ECOG performance status of 0 or 1
- Expected survival of 3 months or more
- Adequate vital organ function including neutrophil count ≥1.0×10^9/L, platelet count ≥80×10^9/L, hemoglobin ≥90 g/L
- INR <1.5 and APTT ≤1.5× upper limit of normal
- Liver enzymes (ALT and AST) ≤3× upper limit of normal
- Total bilirubin ≤1.5× upper limit of normal
- Serum creatinine ≤1.5× upper limit of normal
- Left ventricular ejection fraction ≥45%
- ECG QTcF interval <470 ms
- Fertile females must agree to use effective contraception and have a negative pregnancy test before first dose
- Male participants with fertile partners must agree to use effective contraception
You will not qualify if you...
- Previous adoptive cell therapy such as tumor-infiltrating lymphocytes, CAR-T, or TCR-T
- Prior or planned organ, stem cell, or bone marrow transplantation
- Congenital or acquired immunodeficiency or HIV infection
- Autoimmune diseases except hypothyroidism requiring hormone replacement
- History of epilepsy, central nervous system disease, or lymphoma involving CNS
- Other active malignancies except those disease-free over 3 years or carcinoma in situ
- History of allergy to blood products or study substances
- Persistent non-hematological toxicity above grade 1 except hair loss and peripheral neuropathy
- Major surgery within 4 weeks before treatment or planned during study
- Severe or uncontrolled cardiovascular disease
- Known bleeding or clotting disorders
- History or active interstitial pneumonia or pulmonary fibrosis
- Recent severe infection or active infection requiring treatment
- Active hepatitis B, C, CMV, EBV, HIV, or syphilis infection
- Planned live vaccine within 28 days before or during study and 90 days after treatment
- Other factors judged by investigators that may affect study or lead to early termination
- Pregnancy or breastfeeding within 6 months after last study drug administration
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 201200
Actively Recruiting
Research Team
R
Rong Tao, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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