NCT04656535

AB154 Combined With AB122 for Recurrent Glioblastoma

Active, enrolled EARLY_PHASE1 Last updated 17 April 2026

What this trial tests

EARLY_PHASE1 trial testing Zimberelimab in Glioblastoma in 46 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

21 April 2021

Primary endpoint
17 March 2026

31 December 2026

Quick facts

Lead sponsor	Yale University
Phase	EARLY_PHASE1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	triple
Primary purpose	treatment
Enrollment	46
Start date	21 April 2021
Primary completion	17 March 2026
Estimated completion	31 December 2026
Sites	3 locations across United States

Drugs / interventions tested

• Zimberelimab — full drug profile →
• Domvanalimab — full drug profile →
• Placebo

Conditions studied

• Glioblastoma — all drugs for Glioblastoma →

Sponsor

Yale University

Who can join

18 and older, any sex, with Glioblastoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase 0/I exploratory study. Patients at first or second recurrence of glioblastoma will be enrolled. The study will be divided into two cohorts: Cohort A (safety cohort) and Cohort B (surgical patient cohort).

Cohort A: Eligible patients will be sequentially enrolled to receive intravenous domvanalimab combined with zimberelimab (N=6). Domvanalimab will be given at a dose of 10 mg/kg and zimberelimab will be given at a dose of 240 mg (flat). The dosing was determined in a separate study in solid tumors; this cohort will confirm the safety of the dosing schedule in patients with brain tumors.

Cohort B: Expansion surgical cohort. The purpose of cohort B is to provide an additional safety evaluation of domvanalimab + zimberelimab as well as tissue and blood for exploratory ancillary studies investigating the effects of domvanalimab + zimberelimab in the tumor and tumor microenvironment. A total of 46 patients will be enrolled in this cohort.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Applications of single-cell sequencing in cancer research: progress and perspectives.
   Lei Y, Tang R, Xu J, Wang W, et al · · 2021 · cited 428× · PMID 34108022 · DOI 10.1186/s13045-021-01105-2
2. Immunosuppressive cells in cancer: mechanisms and potential therapeutic targets.
   Tie Y, Tang F, Wei YQ, Wei XW. · · 2022 · cited 386× · PMID 35585567 · DOI 10.1186/s13045-022-01282-8
3. Understanding the immunosuppressive microenvironment of glioma: mechanistic insights and clinical perspectives.
   Lin H, Liu C, Hu A, Zhang D, et al · · 2024 · cited 232× · PMID 38720342 · DOI 10.1186/s13045-024-01544-7
4. Tumor microenvironment in glioblastoma: Current and emerging concepts.
   Sharma P, Aaroe A, Liang J, Puduvalli VK. · · 2023 · cited 202× · PMID 36968288 · DOI 10.1093/noajnl/vdad009
5. Immunotherapy for glioblastoma: current state, challenges, and future perspectives.
   Liu Y, Zhou F, Ali H, Lathia JD, et al · · 2024 · cited 189× · PMID 39406966 · DOI 10.1038/s41423-024-01226-x
6. TIGIT, the Next Step Towards Successful Combination Immune Checkpoint Therapy in Cancer.
   Ge Z, Peppelenbosch MP, Sprengers D, Kwekkeboom J. · · 2021 · cited 166× · PMID 34367161 · DOI 10.3389/fimmu.2021.699895
7. Co-inhibition of TIGIT and PD-1/PD-L1 in Cancer Immunotherapy: Mechanisms and Clinical Trials.
   Chu X, Tian W, Wang Z, Zhang J, et al · · 2023 · cited 147× · PMID 37291608 · DOI 10.1186/s12943-023-01800-3
8. Natural killer cells: a promising immunotherapy for cancer.
   Chu J, Gao F, Yan M, Zhao S, et al · · 2022 · cited 140× · PMID 35606854 · DOI 10.1186/s12967-022-03437-0