BridgeMD
New treatment option for Primary CNS Lymphoma (PCNSL)
Official title Anbalcabtagene Autoleucel in Relapsed/Refractory CNS Lymphoma
ClinicalTrials.gov ID: NCT07062627
What this study is testing
What is Anbal-cel?
Anbal-cel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for primary cns lymphoma (pcnsl).
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 clinical study aims to evaluate the tolerability, safety, and efficacy of Anbal-cel in patients with recurrent or refractory PCNSL or SCNSL. Subjects who have provided written consent and meet the inclusion and exclusion criteria through screening evaluations will undergo leukapheresis (LP) for Anbal-cel manufacturing.
- 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 19 and older
You may be able to join if
- Individuals aged 19 years or older who voluntarily agree to participate in this clinical study and provide written consent.
- Patients with recurrent/refractory B-cell lymphoma confirmed histologically according to the 2017 WHO classification, and who meet one of the...
- Patients who failed treatment with a previous regimen that included high-dose methotrexate or patients intolerant to high-dose methotrexate.
- Patients who agree to provide tumor tissue. If a stored tumor tissue sample is available, it can be submitted only if it was collected within 6...
- Individuals with an ECOG performance status score of 2 or lower at the time of screening.
You likely can't join if
- Individuals with a history of allogeneic hematopoietic stem cell transplantation.
- Individuals with the following medical history:
- History of other malignancies, except B-cell non-Hodgkin lymphoma, within 3 years prior to screening (however, individuals with a history of basal...
- History of unstable angina and/or myocardial infarction within 12 months prior to screening.
- History of thromboembolism, pulmonary embolism, or bleeding diatheses within 6 months prior to screening.
- History of hypoxia, clinically significant pleural effusion, or abnormal electrocardiogram findings within 6 months prior to screening.
See the full eligibility criteria
- Individuals aged 19 years or older who voluntarily agree to participate in this clinical study and provide written consent.
- Patients with recurrent/refractory B-cell lymphoma confirmed histologically according to the 2017 WHO classification, and who meet one of the following conditions: Primary central nervous system lymphoma (PCNSL) of the...
- Patients who failed treatment with a previous regimen that included high-dose methotrexate or patients intolerant to high-dose methotrexate.
- Patients who agree to provide tumor tissue. If a stored tumor tissue sample is available, it can be submitted only if it was collected within 6 months prior to participation in the clinical study and if no systemic...
- Individuals with an ECOG performance status score of 2 or lower at the time of screening.
- Individuals with appropriate renal and liver function confirmed by laboratory test results: Total Bilirubin ≤2.0 mg/dL (for individuals with Gilbert-Meulengracht syndrome: total bilirubin ≤3.0 × upper limit of normal...
- Individuals with appropriate hematologic function confirmed within 2 weeks prior to screening without transfusion, based on the following criteria: Hemoglobin \>8.0 g/dL Absolute neutrophil count (ANC) \>1,000/μL...
- Individuals who are hemodynamically stable at the time of screening, have no signs of pericardial effusion, and have a left ventricular ejection fraction of 50% or higher based on an echocardiogram (ECHO) or multigated...
- Individuals from whom adequate non-mobilized cells for Anbal-cel manufacturing can be collected through leukapheresis.
- Individuals with an expected survival of 12 weeks or longer.
- Individuals who agree to comply with the scheduled site visits, examination schedules, and assessments as per the protocol during the course of the clinical study, including primary and secondary follow-up visits.
- Women of childbearing potential and men who agree to use appropriate contraception\ for at least 12 months after Anbal-cel administration until Anbal-cel is no longer detected in PCR tests. \ Hormonal contraception...
- Individuals with a history of allogeneic hematopoietic stem cell transplantation.
- Individuals with the following medical history:
- History of other malignancies, except B-cell non-Hodgkin lymphoma, within 3 years prior to screening (however, individuals with a history of basal cell carcinoma, squamous cell carcinoma of the skin, localized prostate...
- History of unstable angina and/or myocardial infarction within 12 months prior to screening.
- History of thromboembolism, pulmonary embolism, or bleeding diatheses within 6 months prior to screening.
- History of hypoxia, clinically significant pleural effusion, or abnormal electrocardiogram findings within 6 months prior to screening.
- Individuals with the following conditions at the time of screening:
- Known positive for human immunodeficiency virus (HIV).
- Active neurological autoimmune or inflammatory diseases (e.g., Guillain-Barré syndrome, amyotrophic lateral sclerosis).
- Recurrent or symptomatic ventricular tachycardia or atrial fibrillation with rapid ventricular response despite treatment in the 3 months prior to screening.
- Individuals whose disease is rapidly progressing, as determined by the investigator.
- Individuals who have undergone major surgery requiring general anesthesia or respiratory support within 4 weeks prior to screening (however, video-assisted thoracoscopic surgery (VATS) or open-and-closed (ONC) surgery...
- Individuals with severe infections requiring the administration of antibiotics, antifungals, or antivirals at the time of screening or with uncontrolled active infections.
- Individuals who have received or been exposed to other investigational drugs or devices within 4 weeks prior to screening.
- Pregnant or breastfeeding women.
- Individuals with a hypersensitivity to the ingredients of the investigational drug.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
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, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. 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.