BridgeMD
New treatment option for Lymphoma Patients With Complete Response (CR) or Partial Response (PR)...
Official title RGL-305+ Lymphoma + Exploratory Clinical Study
ClinicalTrials.gov ID: NCT07006012
What this study is testing
What is RGL-305?
RGL-305 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lymphoma patients with complete response (cr) or partial response (pr) after standard treatment had a positive minimal residual lesion (mrd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Be willing to provide blood or tissue samples required for cytodynamic and biomarker detection before and after treatment;
- ECOG score is 0 or 1;
You likely can't join if
- Previous adoptive cell therapy, including but not limited to tumor-infiltrating lymphocytes (TILs), chimeric antigen receptor T cells (CAR-T), and 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...
- 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;
See the full eligibility criteria
- 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 how well it works evaluation criteria were CR or...
- 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;
- 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 people 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...
- 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...
- 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;
- 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...
- Known hereditary or acquired bleeding or thrombotic tendencies;
- people 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...
- 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...
- 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, people considering fertility, female people became pregnant or breastfed within 6 months of the last study drug administration.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.