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Anbalcabtagene Autoleucel in Relapsed/Refractory CNS Lymphoma

NCT07062627 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-12-17

No results posted yet for this study

Summary

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

  • Primary CNS Lymphoma (PCNSL)
  • Diffuse Large B Cell Lymphoma (DLBCL)

Interventions

GENETIC

Anbal-cel

On 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

Sponsors & Collaborators

  • Asan Medical Center

    collaborator OTHER

  • Hyungwoo Cho

    lead OTHER

Principal Investigators

  • Hyungwoo Cho, Ph.D · Asan Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-12
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07062627 on ClinicalTrials.gov