Anbalcabtagene Autoleucel in Relapsed/Refractory CNS Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorHyungwoo Cho
About this trial
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. Subjects whose collected nucleated cells are confirmed suitable for Anbal-cel production will be enrolled in the clinical study.
Prior to Anbal-cel administration, lymphodepletion therapy will be performed and must be completed at least 2 days before Anbal-cel administration. Anbal-cel will be administered to subjects who meet the inclusion and exclusion criteria for Anbal-cel administration.
Study subjects will be hospitalized for a minimum of 7 days to closely monitor adverse events and receive prompt necessary treatment after Anbal-cel administration. All study subjects will undergo primary visit evaluations for 12 months following Anbal-cel administration.
Subjects who discontinue primary visit evaluations before the 12-month visit will undergo an end of study 1 (EOS1) visit for safety observation. For subjects whose primary visit evaluations end before the 12-month visit due to disease progression (PD), withdrawal of consent for primary visit evaluations, or subsequent anti-cancer therapy, secondary follow-up visits will be conducted from the EOS1 visit to the 12-month time point (EOS2). The timing of the first secondary follow-up visit will be determined based on when the subject's primary visit evaluation was discontinued.
A separate long-term follow-up study is planned to monitor long-term safety, including delayed adverse events (AEs), in subjects who received Anbal-cel. In this long-term follow-up study, each subject will be followed for 15 years from the date of Anbal-cel administration. All specific details, including the visit schedule and examination items for the long-term follow-up study, will be described in a separate protocol.
Eligibility criteria
Qualifiers
Individuals aged 19 years or older who voluntarily agree to participate in this clinical study and provide written consent.
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 anticancer treatment was administered after collection. If the stored tissue sample does not meet these conditions, tumor tissue must be obtained through a core needle biopsy or excisional biopsy during the screening period. If the investigator deems the biopsy to be medically unsafe for the patient, the decision on whether to enroll the patient in the clinical study can be made in consultation with the patient's clinical physician.
Individuals with an ECOG performance status score of 2 or lower at the time of screening.
Disqualifiers
Individuals with a history of allogeneic hematopoietic stem cell transplantation.
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 cancer, papillary thyroid cancer, cervical carcinoma in situ, or early-stage gastric cancer may participate if the investigator considers them to be fully cured after successful treatment, even if 3 years have not passed).
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.
Trial design
Treatments tested in this trial
- Anbal-cel
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov