NCT06241456

FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibodies in Advanced Solid Tumors

Recruiting now Phase 1 Last updated 9 December 2025

What this trial tests

Phase 1 trial testing FT825 in Advanced Solid Tumor in 351 participants. Currently enrolling.

Timeline

5 January 2024

Primary endpoint
1 May 2029

1 May 2044

Quick facts

Lead sponsor	Fate Therapeutics
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	351
Start date	5 January 2024
Primary completion	1 May 2029
Estimated completion	1 May 2044
Sites	14 locations across United States

Drugs / interventions tested

• FT825 — full drug profile →
• Fludarabine (FLUDARABINE) — full drug profile →
• Cyclophosphamide (cyclophosphamide) — full drug profile →
• Bendamustine (BENDAMUSTINE) — full drug profile →
• Docetaxel
• Cisplatin (cisplatin) — full drug profile →
• Cetuximab

Conditions studied

• Advanced Solid Tumor — all drugs for Advanced Solid Tumor →

Sponsor

Fate Therapeutics — full company profile →

Who can join

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

Sponsor's own description

This is a phase 1 study designed to evaluate the safety, tolerability, and antitumor activity of FT825 (also known as ONO-8250) with or without monoclonal antibody therapy following chemotherapy in participants with advanced human epidermal growth factor receptor 2 (HER2)-positive or other advanced solid tumors. The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT825 in indication-specific cohorts.

Publications & conference data

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

1. Induced pluripotent stem cells (iPSCs): molecular mechanisms of induction and applications.
   Cerneckis J, Cai H, Shi Y. · · 2024 · cited 248× · PMID 38670977 · DOI 10.1038/s41392-024-01809-0
2. Progress and pitfalls of gene editing technology in CAR-T cell therapy: a state-of-the-art review.
   Moradi V, Khodabandehloo E, Alidadi M, Omidkhoda A, et al · · 2024 · cited 24× · PMID 38912057 · DOI 10.3389/fonc.2024.1388475
3. Combining the induced pluripotent stem cell (iPSC) technology with chimeric antigen receptor (CAR)-based immunotherapy: recent advances, challenges, and future prospects.
   Alidadi M, Barzgar H, Zaman M, Paevskaya OA, et al · · 2024 · cited 18× · PMID 39624236 · DOI 10.3389/fcell.2024.1491282
4. Combinational CAR T-cell therapy for solid tumors: Requisites, rationales, and trials.
   Misawa K, Bhat H, Adusumilli PS, Hou Z. · · 2025 · cited 11× · PMID 39617146 · DOI 10.1016/j.pharmthera.2024.108763
5. A Cancer-Specific Anti-Podoplanin Monoclonal Antibody, PMab-117-mG_2a Exerts Antitumor Activities in Human Tumor Xenograft Models.
   Tanaka T, Suzuki H, Ohishi T, Kaneko MK, et al · · 2024 · cited 9× · PMID 39594582 · DOI 10.3390/cells13221833
6. Anti-HER2 Cancer-Specific mAb, H₂Mab-250-hG₁, Possesses Higher Complement-Dependent Cytotoxicity than Trastuzumab.
   Suzuki H, Ohishi T, Tanaka T, Kaneko MK, et al · · 2024 · cited 8× · PMID 39125956 · DOI 10.3390/ijms25158386
7. Anti-CD44 Variant 10 Monoclonal Antibody Exerts Antitumor Activity in Mouse Xenograft Models of Oral Squamous Cell Carcinomas.
   Ishikawa K, Suzuki H, Ohishi T, Li G, et al · · 2024 · cited 5× · PMID 39273139 · DOI 10.3390/ijms25179190
8. Research progress on HER2-specific chimeric antigen receptor T cells for immunotherapy of solid tumors.
   Zhu L, Liu J, Li J, Wang N, et al · · 2025 · cited 3× · PMID 40469307 · DOI 10.3389/fimmu.2025.1514994