Lymphoma Patients With Complete Response (CR) or Partial Response (PR) After Standard Treatment Had a Positive Minimal Residual Lesion (MRD)NCT07006012
RGL-305+ Lymphoma + Exploratory Clinical Study
A study testing RGL-305 in people with Lymphoma Patients With Complete Response (CR) or Partial Response (PR) After Standard Treatment Had a Positive Minimal Residual Lesion (MRD), run by Fudan University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lymphoma Patients With Complete Response (CR) or Partial Response (PR) After Standard Treatment Had a Positive Minimal Residual Lesion (MRD)
- What is being tested?
- RGL-305
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 21 Apr 2025to 31 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate in the study and sign a written informed consent
- Age 18-75 years old (including the boundary value), gender is not limited;
- 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.
- Be willing to provide blood or tissue samples required for cytodynamic and biomarker detection before and after treatment;
- ECOG score is 0 or 1;
- Expected survival ≥3 months;
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- The function of vital organs meets the following criteria:
- Neutrophil absolute value (ANC) ≥1.0×109/L;
- Platelet count (PLT) ≥80×109/L;
- Hemoglobin (Hb) ≥90g/L;
- International standardized ratio (INR<1.5), activated partial thromboplastin time (APTT) ≤1.5×ULN;
- Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 times the upper limit of normal (ULN);
- Total bilirubin (TBIL) ≤1.5×ULN;
- Serum creatinine (Scr) ≤1.5×ULN;
- Left ventricular ejection fraction (LVEF) ≥45%;
- 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.
- 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)
Who cannot join
- 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);
- Have previously received or planned to undergo organ transplantation or allogeneic stem cell or allogeneic bone marrow transplantation;
- 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);
- The presence of autoimmune diseases, except for patients with hypothyroidism due to autoimmune thyroiditis who only need hormone replacement therapy;
- History of epilepsy or other central nervous system diseases, or lymphoma invading the central nervous system;
- Complicated with other malignant tumors, except malignant tumors with disease-free survival of more than 3 years and carcinoma in situ;
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- History of allergy to blood products, known to be allergic to test substances;
- Any non-hematological toxicity associated with previous treatment does not return to ≤ grade 1, except for hair loss and peripheral neurotoxicity;
- 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;
- 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);
- Known hereditary or acquired bleeding or thrombotic tendencies;
- 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;
- 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;
- Active hepatitis B (HBV), hepatitis C (HCV), cytomegalovirus (CMV), EB virus (EBV), HIV, syphilis infection;
- 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;
- 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;
- During the study period, subjects considering fertility, female subjects became pregnant or breastfed within 6 months of the last study drug administration.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 201200
Rong Tao, M.D, 021-33676001, rtao@shca.org.cn
About this study
Official title: An Exploratory Clinical Study to Evaluate the Safety and Cytodynamic Characteristics of RGL-305 in Patients With Lymphoma
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.
Read the 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)
- Being tested
- RGL-305
- Keywords
- Lymphoma, DLBCL
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RGL-305Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| In the RGL-305 low dose group, 3 to 6 subjects were planned to be enrolled in each dose | Experimental | Not described Receives: Drug: RGL-305 |
| In the RGL-305 high dose group, 3 to 6 subjects were planned to be enrolled in each dose group | Experimental | Not described Receives: Drug: RGL-305 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of RGL-305
Incidence and severity of adverse events (AE)/serious adverse events (SAE) (severity based on CTCAE v 5.0 criteria) and association of adverse events with the investigational drug
- Dose limiting toxicity (DLT) incidence of DLT during the observation period
Measured: up to 2 years
Secondary outcomes (1)
To evaluate the cytodynamics of RGL-305 after reinfusion
Flow cytometry was used to detect the number and proportion of Target cells in peripheral blood and the changes compared with baseline
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start21 Apr 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma Patients With Complete Response (CR) or Partial Response (PR) After Standard Treatment Had a Positive Minimal Residual Lesion (MRD)Studies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rong Tao, Fudan University
- Investigators
- Rong Tao, M.D, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006012
- Sponsor's protocol ID
- RGL-305-IIT-Lymphoma
- Status last verified
- Mar 2026
- First submitted
- 2 May 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study to Evaluate the Safety and Cytodynamic Characteristics of RGL-305 in Patients With Lymphoma
- ClinicalTrials.gov ID
- NCT07006012
- Acronym / sponsor ID
- RGL-305-IIT-Lymphoma
- Keywords
- Lymphoma, DLBCL
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In the RGL-305 low dose group, 3 to 6 subjects were planned to be enrolled in each dose | Experimental | Drug: RGL-305 |
| In the RGL-305 high dose group, 3 to 6 subjects were planned to be enrolled in each dose group | Experimental | Drug: RGL-305 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Voluntarily participate in the study and sign a written informed consent
- Age 18-75 years old (including the boundary value), gender is not limited;
- 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.
- Be willing to provide blood or tissue samples required for cytodynamic and biomarker detection before and after treatment;
- ECOG score is 0 or 1;
Key exclusion criteria (17 listed)
- 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);
- Have previously received or planned to undergo organ transplantation or allogeneic stem cell or allogeneic bone marrow transplantation;
- 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);
- The presence of autoimmune diseases, except for patients with hypothyroidism due to autoimmune thyroiditis who only need hormone replacement therapy;
- History of epilepsy or other central nervous system diseases, or lymphoma invading the central nervous system;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RGL-305RGL-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. | Drug | In the RGL-305 high dose group, 3 to 6 subjects were planned to be enrolled in each dose group, In the RGL-305 low dose group, 3 to 6 subjects were planned to be enrolled in each dose |
Primary outcome
To evaluate the safety and tolerability of RGL-305
Time frame: up to 2 years
Incidence and severity of adverse events (AE)/serious adverse events (SAE) (severity based on CTCAE v 5.0 criteria) and association of adverse events with the investigational drug - Dose limiting toxicity (DLT) incidence of DLT during the observation period
1 secondary outcome
To evaluate the cytodynamics of RGL-305 after reinfusion
Time frame: up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rong Tao, M.D principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RGL-305 in people with Lymphoma Patients With Complete Response (CR) or Partial Response (PR) After Standard Treatment Had a Positive Minimal Residual Lesion (MRD), run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rong Tao, M.D (021-33676001, rtao@shca.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of RGL-305 (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.