NCT07062627

Anbalcabtagene Autoleucel in Relapsed/Refractory CNS Lymphoma

Recruiting now Phase 2 Last updated 17 December 2025

What this trial tests

Phase 2 trial testing Anbal-cel in Primary CNS Lymphoma (PCNSL) in 12 participants. Currently enrolling.

Timeline

12 November 2025

Primary endpoint
31 December 2026

31 December 2027

Quick facts

Lead sponsor	Hyungwoo Cho
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	12 November 2025
Primary completion	31 December 2026
Estimated completion	31 December 2027
Sites	1 location across South Korea

Drugs / interventions tested

• Anbal-cel

Conditions studied

• Primary CNS Lymphoma (PCNSL) — all drugs for Primary CNS Lymphoma (PCNSL) →
• Diffuse Large B Cell Lymphoma (DLBCL) — all drugs for Diffuse Large B Cell Lymphoma (DLBCL) →

Sponsor

Hyungwoo Cho

Who can join

19 and older, any sex, with Primary CNS Lymphoma (PCNSL) or Diffuse Large B Cell Lymphoma (DLBCL). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Unraveling the immune microenvironment in primary CNS lymphoma.
   Lorenzen S, Zeremski V, Berisha M, Mougiakakos D, et al · · 2026 · PMID 42226261 · DOI 10.1186/s40364-026-00945-9