BridgeMD
New treatment option for B-cell Lymphoma Refractory
Official title Polymer-lipid Particle-delivered CAR1920 mRNA CAR-T Therapy for Relapsed/Refractory B-cell Lymphoma/Leukemia
ClinicalTrials.gov ID: NCT07321301
What this study is testing
What is Polymer-Lipid Nanoparticle-Mediated Delivery of CD19/CD20 Dual-Targeting InViVoCAR1920 mRNA for CAR-T Cell Immunotherapy?
Polymer-Lipid Nanoparticle-Mediated Delivery of CD19/CD20 Dual-Targeting InViVoCAR1920 mRNA for CAR-T Cell Immunotherapy is an investigational medicine, being studied as a potential treatment for b-cell lymphoma refractory.
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
- The purpose of this study is to determine the efficacy and safety of the CAR-T cell immunotherapy utilizing polymer-lipid nanoparticles for delivering CD19/CD20 dual-targeting InViVoCAR1920 mRNA, for the first-line consolidation therapy of relapsed/refractory B-cell lymphoma/leukemia.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 85
You may be able to join if
- Has voluntarily given informed consent, signed the informed consent form, and is willing and able to comply with the scheduled visits, study...
- Patients with relapsed/refractory (R/R) B-cell lymphoma/leukemia confirmed by histopathology, cytogenetics, molecular biology, clinical judgment...
- Must meet the following criteria for R/R B-cell malignant tumors: (1) B-cell tumors include 3 categories:
- B-cell acute lymphoblastic leukemia (B-ALL); ② Indolent B-cell lymphomas, including chronic lymphocytic leukemia (CLL), follicular lymphoma (FL)...
- Relapse within 6 months after the first complete response (CR);
You likely can't join if
- Previous receipt of any form of chimeric antigen receptor (CAR) cell therapy or other genetically modified T-cell therapies;
- History of severe immediate-type hypersensitivity reactions to commonly used drugs such as aminoglycoside antibiotics;
- Known history of Human Immunodeficiency Virus (HIV) infection, active Hepatitis B Virus (HBV) infection, or any uncontrolled active systemic...
- Hepatic or renal impairment unrelated to hematologic malignancies (e.g., lymphoma): ALT \> 3 × ULN, AST \> 3 × ULN, TBIL \> 2 × ULN, or serum...
- History of myocardial infarction, cardiac angioplasty, coronary artery stenting, unstable angina pectoris, active arrhythmia, or other clinically...
- Other severe medical conditions that may affect the study (e.g., poorly controlled diabetes mellitus, gastric ulcer, other severe cardiorespiratory...
See the full eligibility criteria
Who can join
- Has voluntarily given informed consent, signed the informed consent form, and is willing and able to comply with the scheduled visits, study treatment, laboratory tests, imaging examinations, and other necessary trial...
- Patients with relapsed/refractory (R/R) B-cell lymphoma/leukemia confirmed by histopathology, cytogenetics, molecular biology, clinical judgment, medical history, and other assessment methods in accordance with the WHO...
- Must meet the following criteria for R/R B-cell malignant tumors: (1) B-cell tumors include 3 categories:
- B-cell acute lymphoblastic leukemia (B-ALL); ② Indolent B-cell lymphomas, including chronic lymphocytic leukemia (CLL), follicular lymphoma (FL), marginal zone lymphoma (MZL), lymphoplasmacytic lymphoma (LPL), hairy...
- Relapse within 6 months after the first complete response (CR);
- Primary refractory patients who failed to achieve CR after 2 cycles of standard chemotherapy;
- Failure to achieve CR or relapse after first-line or multi-line salvage chemotherapy; ④ Relapse after hematopoietic stem cell transplantation (HSCT); (3) R/R B-cell lymphoma (meeting any 1 of the first 4 criteria below...
- Tumor reduction \< 50% or disease progression after 4 courses of standardized chemotherapy per standard regimens;
- Relapse within 6 months after achieving CR with standard chemotherapy;
- ≥ 2 relapses after CR;
- Relapse after HSCT; ⑤ Adequate prior treatment received, including at least anti-CD20 monoclonal antibody and anthracycline-containing combination chemotherapy regimens; 4. Aged 18-85 years (inclusive), male or female...
- Total Bilirubin (TBIL) ≤ 1.5 × Upper Limits of Normal (ULN), excluding people with Gilbert's syndrome;
- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 × ULN;
- Serum Creatinine (Cr) ≤ 1.5 × ULN or Creatinine Clearance Rate (CCr) ≥ 60 mL/min (CCr estimated by the Cockcroft-Gault formula);
- Left Ventricular Ejection Fraction (LVEF) ≥ 50%; echocardiogram (ECHO) confirms no clinically significant severe pericardial effusion or severe arrhythmia;
- Baseline transcutaneous oxygen saturation \> 90% under room air;
- No clinically significant severe pleural effusion; 10. people with pregnancy plans must agree to use contraceptive measures from before study enrollment until 6 months after the end of the study;
What rules you out
- Previous receipt of any form of chimeric antigen receptor (CAR) cell therapy or other genetically modified T-cell therapies;
- History of severe immediate-type hypersensitivity reactions to commonly used drugs such as aminoglycoside antibiotics;
- Known history of Human Immunodeficiency Virus (HIV) infection, active Hepatitis B Virus (HBV) infection, or any uncontrolled active systemic infection requiring intravenous antibiotics (active HBV infection is defined...
- Hepatic or renal impairment unrelated to hematologic malignancies (e.g., lymphoma): ALT \> 3 × ULN, AST \> 3 × ULN, TBIL \> 2 × ULN, or serum creatinine clearance \< 30 mL/min;
- History of myocardial infarction, cardiac angioplasty, coronary artery stenting, unstable angina pectoris, active arrhythmia, or other clinically significant cardiovascular diseases within 12 months prior to enrollment;
- Other severe medical conditions that may affect the study (e.g., poorly controlled diabetes mellitus, gastric ulcer, other severe cardiorespiratory diseases, concurrent severe autoimmune diseases or congenital...
- History of severe immediate-type hypersensitivity reactions to any specific drugs required in this study; or history of severe hypersensitivity to biological products (including antibiotics);
- Female people who are pregnant or lactating (due to potential risks of treatment to the fetus or infant);
- people judged by the investigator to be unable to complete all scheduled visits, investigations, or diagnostic and therapeutic procedures required by the study protocol (including medium- and long-term follow-up...
- Concurrent progressive malignant tumors of other types; or a history of other malignant tumors, except for non-melanoma skin cancers and carcinoma in situ (e.g., of the cervix, bladder, or breast). people with a history...
- History of live vaccine vaccination within 6 weeks prior to the start of the conditioning regimen;
- Receipt of major surgical procedures (excluding lymph node biopsy) within the past 14 days, or anticipated need for major surgery during the treatment period;
- Other severe physical or mental illnesses or laboratory abnormalities that may increase the risk of study participation or interfere with study results, as well as patients deemed unsuitable for participation by the...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing 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, 14 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing 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.