New cell therapy aims to mop up lingering lymphoma
NCT ID NCT07006012
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tests a new cell therapy called RGL-305 in 12 lymphoma patients who still have traces of cancer after standard treatment. The therapy is given through an IV over several cycles. The main goal is to check if it is safe and how the cells behave in the body, not yet to prove it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RGL-305 (a cell therapy given intravenously)
- What this could lead to
- If it works, this could point toward a new way to eliminate remaining cancer cells in lymphoma patients who still have minimal disease after standard treatment.
- What could go wrong
- This is a very early, small study with only 12 participants, so results may not apply broadly. The main goal is safety, not yet proof of effectiveness, and cell therapies can cause serious side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Voluntarily participate in the study and sign a written informed consent 2. Age 18-75 years old (including the boundary value), gender is not limited; 3. Patients with pathologically confirmed lymphoma who have previously received at least one standard treatment. After the last treatment, patients with Lugano 2014 lymphoma efficacy evaluation criteria were CR or PR, and MRD was positive. Patients with PR were required to have a Deauville score of 4. 4. Be willing to provide blood or tissue samples required for cytodynamic and biomarker detection before and after treatment; 5. ECOG score is 0 or 1; 6. Expected survival ≥3 months; 7. The function of vital organs meets the following criteria: 1. Neutrophil absolute value (ANC) ≥1.0×109/L; 2. Platelet count (PLT) ≥80×109/L; 3. Hemoglobin (Hb) ≥90g/L; 4. International standardized ratio (INR\<1.5), activated partial thromboplastin time (APTT) ≤1.5×ULN; 5. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 times the upper limit of normal (ULN); 6. Total bilirubin (TBIL) ≤1.5×ULN; 7. Serum creatinine (Scr) ≤1.5×ULN; 8. Left ventricular ejection fraction (LVEF) ≥45%; 9. Electrocardiogram: Fridericia corrected QT interval (QTcF) \<470 ms; The QTc interval must be corrected according to Fridericia's standard with the correction formula QTcF=QT/RR\^0.33. 8. Fertile female subjects must agree to effective contraception and refrain from egg donation for 6 months from the signing of the informed consent until the last administration of the investigational drug, the serum pregnancy test must be negative within 7 days prior to the first administration, and they are not lactating; Male subjects whose partner is a fertile woman must agree to highly effective contraception and refrain from sperm donation from signing the informed consent until 6 months after the final administration of the investigational drug (see Annex 6 for details) Exclusion Criteria: 1. Previous adoptive cell therapy, including but not limited to tumor-infiltrating lymphocytes (TILs), chimeric antigen receptor T cells (CAR-T), and T cell receptor chimeric T cells (TCR-T); 2. Have previously received or planned to undergo organ transplantation or allogeneic stem cell or allogeneic bone marrow transplantation; 3. Combined with congenital or acquired immunodeficiency such as cellular immunodeficiency (e.g., DiGeorge syndrome, T-negative severe combined immunodeficiency \[SSCID\]) or combined T-cell and B-cell immunodeficiency (e.g., T-and B-negative combined immunodeficiency, Wiskott-Aldrich syndrome, ataxic telangiectasia, often) See variable immune deficiency); Or infected with human immunodeficiency virus (HIV); 4. The presence of autoimmune diseases, except for patients with hypothyroidism due to autoimmune thyroiditis who only need hormone replacement therapy; 5. History of epilepsy or other central nervous system diseases, or lymphoma invading the central nervous system; 6. Complicated with other malignant tumors, except malignant tumors with disease-free survival of more than 3 years and carcinoma in situ; 7. History of allergy to blood products, known to be allergic to test substances; 8. Any non-hematological toxicity associated with previous treatment does not return to ≤ grade 1, except for hair loss and peripheral neurotoxicity; 9. Those who had undergone major surgery (≥ Grade 3 surgery) within 4 weeks before the start of study treatment, or who required elective surgery during the trial period; 10. Have an poorly controlled or severe cardiovascular disease, such as symptomatic congestive heart failure (NYHA class III or IV), a myocardial infarction within 6 months prior to study initiation, or unstable angina within 1 month prior to study initiation, or an arrhythmia requiring treatment or intervention, Or hypertension remains poorly controlled after adequate treatment (systolic blood pressure ≥150mmHg, diastolic blood pressure ≥90mmHg); 11. Known hereditary or acquired bleeding or thrombotic tendencies; 12. Subjects with a known or highly suspected history of interstitial pneumonia, or evidence of active interstitial pneumonia on chest CT during the pre-screening period; Known history of idiopathic pulmonary fibrosis, institutional pneumonia (such as bronchiolitis obliterans or cryptogenic institutional pneumonia); Subjects who may interfere with the detection or management of suspected drug-related pulmonary toxicity; 13. A severe infection occurring within 28 days prior to study initiation (such as intravenous antibiotics, antifungal, or antiviral drugs as required by clinical practice), or an active infection receiving therapeutic intravenous or oral antibiotics within 14 days prior to study initiation, or an unexplained fever; 14. Active hepatitis B (HBV), hepatitis C (HCV), cytomegalovirus (CMV), EB virus (EBV), HIV, syphilis infection; 15. Plan to receive live attenuated vaccine (inactivated vaccine is allowed) within 28 days before the start of study treatment or during the study period and 90 days after the end of study drug treatment; 16. In the investigator's judgment, the subject has other factors that may affect the study results or lead to the forced termination of the study treatment; 17. During the study period, subjects considering fertility, female subjects became pregnant or breastfed within 6 months of the last study drug administration.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fudan University Shanghai Cancer Center
RECRUITINGShanghai, Shanghai Municipality, 201200, China