RGL-305+ Lymphoma + Exploratory Clinical Study

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

NCT07006012•Fudan University

View on ClinicalTrials.gov

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)

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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;
+7 more criteria

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);
+7 more criteria

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

April 21, 2025

Primary Completion Date

March 31, 2028

Completion Date

December 31, 2031

Last Updated

June 5, 2025

Enrollment

ESTIMATED participants

Conditions

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

Interventions

RGL-305

DRUG

Contacts

Rong Tao, M.D

CONTACT

021-33676001 rtao@shca.org.cn