Actively Recruiting
Anbalcabtagene Autoleucel in Relapsed/Refractory CNS Lymphoma
Led by Hyungwoo Cho · Updated on 2025-12-17
12
Participants Needed
1
Research Sites
111 weeks
Total Duration
On this page
Sponsors
H
Hyungwoo Cho
Lead Sponsor
A
Asan Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Anbalcabtagene Autoleucel in Relapsed/Refractory CNS Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals aged 19 years or older who provide written consent.
- Patients with recurrent or refractory B-cell lymphoma confirmed by 2017 WHO classification, including PCNSL of DLBCL subtype or secondary CNS involvement of DLBCL without other systemic disease.
- Patients who failed previous treatment with high-dose methotrexate or are intolerant to it.
- Agreement to provide tumor tissue collected within 6 months or biopsy during screening if needed.
- ECOG performance status of 2 or lower.
- Adequate kidney and liver function based on laboratory tests.
- Adequate blood counts without recent transfusion.
- Hemodynamically stable with left ventricular ejection fraction of 50% or higher.
- Ability to collect cells suitable for Anbal-cel manufacturing via leukapheresis.
- Expected survival of at least 12 weeks.
- Willingness to comply with study visits and assessments.
- Women and men agreeing to use effective contraception for 12 months after treatment.
You will not qualify if you...
- History of allogeneic hematopoietic stem cell transplantation.
- History of other cancers within 3 years except certain fully treated and cured skin, prostate, thyroid, cervical, or gastric cancers.
- History of unstable angina or heart attack within 12 months.
- History of blood clots, pulmonary embolism, or bleeding disorders within 6 months.
- History of significant hypoxia, pleural effusion, or abnormal ECG within 6 months.
- Known HIV infection.
- Active neurological autoimmune or inflammatory diseases.
- Recent serious heart rhythm problems despite treatment.
- Rapidly progressing disease.
- Major surgery requiring general anesthesia or respiratory support within 4 weeks (some thoracoscopic or minor surgeries allowed if within 2 weeks).
- Severe or uncontrolled infections requiring treatment.
- Use of other investigational drugs or devices within 4 weeks.
- Pregnant or breastfeeding women.
- Known allergy to investigational drug ingredients.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
Research Team
H
Hyungwoo Cho, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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