Actively Recruiting
A Pilot Study of Anbalcabtagene Autoleucel in Patients With Relapsed/Refractory Primary or Secondary Central Nervous System Lymphoma
Led by Hyungwoo Cho · Updated on 2025-12-17
12
Participants Needed
1
Research Sites
52 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
Researchers are evaluating Anbalcabtagene autoleucel (Anbal-cel), an investigational CAR-T cell therapy, in patients with relapsed or refractory primary central nervous system lymphoma (PCNSL) or secondary CNS lymphoma (SCNSL), which are aggressive B-cell lymphomas with poor outcomes. This phase 2, open-label pilot study aims to assess the safety, tolerability, pharmacokinetics, and early effectiveness of Anbal-cel in this patient group, addressing the need for new treatments due to limited success of current options. Participants undergo leukapheresis to collect cells for Anbal-cel manufacturing, followed by lymphodepletion chemotherapy with fludarabine and cyclophosphamide before infusion. Anbal-cel is given as a single intravenous infusion at a dose of 2 x 10^6 CAR-T cells per kilogram, within 30 minutes of thawing. The study includes a safety lead-in phase with initial patients receiving the recommended dose, with ongoing safety assessments before further enrollment. During the study, patients are hospitalized for at least 7 days after receiving Anbal-cel for close monitoring and treatment of any side effects. They will have regular primary evaluations for 12 months, with additional follow-up visits if evaluations end early due to progression or other reasons. A separate 15-year long-term follow-up study will monitor delayed effects and long-term safety. Researchers will measure response rates, survival outcomes, immune responses, and safety over 24 months.
CONDITIONS
Brief 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 to participate
- Patients with recurrent or refractory B-cell lymphoma, including primary CNS lymphoma (PCNSL) of the DLBCL subtype or secondary CNS involvement of DLBCL without systemic disease
- Patients who failed or are intolerant to high-dose methotrexate treatment
- Patients who agree to provide tumor tissue samples collected within 6 months or undergo biopsy if safe
- ECOG performance status of 2 or lower at screening
- Adequate liver and kidney function based on laboratory tests
- Adequate hematologic function without recent transfusion
- Hemodynamically stable with no pericardial effusion and left ventricular ejection fraction ≥50%
- Ability to collect sufficient cells for Anbal-cel manufacturing via leukapheresis
- Expected survival of at least 12 weeks
- Agreement to comply with all scheduled study visits and assessments
- Women of childbearing potential and men agreeing to use effective contraception for at least 12 months after treatment
You will not qualify if you...
- History of allogeneic hematopoietic stem cell transplantation
- History of other malignancies within 3 years except certain fully treated cancers
- History of unstable angina or myocardial infarction within 12 months
- History of thromboembolism, pulmonary embolism, or bleeding disorders within 6 months
- History of hypoxia, significant pleural effusion, or abnormal ECG within 6 months
- Known HIV infection
- Active neurological autoimmune or inflammatory diseases
- Recurrent or symptomatic ventricular tachycardia or atrial fibrillation with rapid response in past 3 months
- Rapidly progressing disease
- Major surgery requiring general anesthesia or respiratory support within 4 weeks (with some exceptions)
- Severe or uncontrolled infections requiring antibiotics, antifungals, or antivirals
- Use of other investigational drugs or devices within 4 weeks
- Pregnant or breastfeeding women
- Hypersensitivity to the investigational drug ingredients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 days
Participants receive lymphodepletion chemotherapy with fludarabine and cyclophosphamide to prepare for Anbal-cel infusion.
Daily visits from Day -5 to Day -2 for chemotherapy administration
Duration - 1 day
Participants receive a single intravenous infusion of Anbal-cel, a CAR-T cell therapy targeting CNS lymphoma.
1 infusion visit (in-person) on Day 1
Duration - Up to 24 months
Participants are monitored for safety, tolerability, and response to treatment, including assessment of adverse events and pharmacokinetics.
Frequent visits initially, then periodic visits for up to 24 months
Duration - Up to 5 years
Participants undergo long-term follow-up for safety and survival outcomes in accordance with gene therapy guidance.
Periodic visits during long-term follow-up
Trial Site Locations
Total: 1 location
1
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
Research Team
H
Hyungwoo Cho, Ph.D
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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