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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Anbal-cel
GeneticOn Day 1 (D1), Anbal-cel will be administered only to subjects who meet the final inclusion/exclusion criteria for Anbal-cel administration before the infusion. As premedication before Anbal-cel administration, acetaminophen or paracetamol, and diphenhydramine or H1 antihistamine will be given. Anbal-cel will be administered as a single intravenous infusion on Day 1 within 30 minutes of thawing, at the dose presented in the following table: Dose: 2x10\^6 (CAR-T cells/kg)\* Maximum 2 x 10\^8 cells
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Anbal-Cel armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The overall response rate (ORR) of Anbal-cel, as determined according to the International Primary CNS Lymphoma Collaborative Group.
The objective response rate (ORR) is defined as the proportion of subjects who achieve a best overall response (BOR) of complete response (CR) or partial response (PR), as assessed by the investigator. Subjects who do not achieve CR or PR will be considered non-responders in the analysis.
Time frame
24 monthsSecondary outcomes
1
Complete response rate (CRR)
The Complete Response Rate (CRR) is defined as the proportion of patients who achieve a complete response (CR) as their best overall response during the study period. CR is determined according to the International Primary CNS Lymphoma Collaborative Group.
Time frame
24 months2
time to response, TTR
Defined as the time from the date of Anbal-cel administration to the date when complete response (CR) or partial response (PR) is first documented.
Time frame
24 months3
Duration of response (DOR)
This analysis will be conducted in subjects who achieve complete response (CR) or partial response (PR). Duration is defined as the time from the first documentation of CR or PR to the earliest occurrence of disease progression (PD), relapse, or death due to the study disease. Survival probability and 95% confidence intervals will be estimated using the Kaplan-Meier method.
Time frame
24 months4
Event-free survival (EFS)
Defined as the time from the date of Anbal-cel administration to the earliest occurrence of disease progression (PD), relapse, initiation of subsequent anti-cancer therapy, or death. The median survival time and two-sided 95% confidence intervals will be estimated by treatment group using the Kaplan-Meier method.
Time frame
24 monthsSponsors and contacts
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Source ClinicalTrials.gov