Advanced Solid TumorPhase 1NCT06241456
FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibodies in Advanced Solid Tumors
A Phase 1 study testing FT825, Fludarabine and Cyclophosphamide in people with Advanced Solid Tumor, run by Fate Therapeutics at 14 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- FT825, Fludarabine and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 351 participants
- Where
- 14 sitesUnited States
- Study dates
- 5 Jan 2024to 1 May 2044
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathological or cytologically confirmed locally advanced or metastatic cancer that meets protocol-defined criteria
- Disease that is not amenable to curative therapy, with prior therapies defined by specific tumor types
- Contraceptive use by women and men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Presence of measurable disease by RECIST, v1.1 assessed within 28 days prior to start of first study intervention
- Anticipated life expectancy of at least 3 months
Who cannot join
- Females who are pregnant or breastfeeding
- Evidence of inadequate organ function
- Clinically significant cardiovascular disease
- Known active central nervous system (CNS) involvement by malignancy
- Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions within 2 years prior to study enrollment
- Active bacterial, fungal, or viral infections
Show all 11Show fewer
- Prior receipt of chimeric antigen receptor (CAR) T-cell therapy, other cellular therapy, or a FATE investigational human induced pluripotent stem cell (iPSC) product
- History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out based on imaging at screening
- Any history of Grade ≥3 immune-related AE or Grade ≥2 eye toxicity attributed to prior cancer immunotherapy, other than endocrinopathy managed with replacement therapy or asymptomatic elevation of serum amylase or lipase
- Active or history of autoimmune disease or immune deficiency
- Receipt of an allograft organ transplant
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites, 14 recruiting
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
- Recruiting
Oncology Hematology Care Clinial Trials
Cincinnati, Ohio, 45242
- Recruiting
Ohio State University - Comprehensive Cancer Center
Columbus, Ohio, 43210
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
- Recruiting
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
University of California San Diego Moores Cancer Center
La Jolla, California, 92037
- Recruiting
University of Minnesota Medical School
Minneapolis, Minnesota, 55455
- Recruiting
Sarah Cannon Research Institute (SCRI) - Oncology Partners
Nashville, Tennessee, 37203
- Recruiting
Yale New Haven Hospital - Yale Cancer Center
New Haven, Connecticut, 06510
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
- Recruiting
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
- Recruiting
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Phase 1 Study of FT825/ONO-8250, an Off-the-Shelf CAR T-Cell Therapy, With or Without Monoclonal Antibodies, in HER2-Positive or Other Advanced Solid Tumors
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.
- Conditions
- Advanced Solid Tumor
- Being tested
- FT825, Fludarabine, Cyclophosphamide, Bendamustine, Docetaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FT825Drug
Also called ONO-8250
FT825 will be administered as an intravenous (IV) infusion at planned dose levels.
FludarabineDrug
Also called FLUDARA
Fludarabine will be administered as an IV infusion at planned dose levels.
CyclophosphamideDrug
Cyclophosphamide will be administered as an IV infusion at planned dose levels.
BendamustineDrug
Bendamustine will be administered as an IV infusion at planned dose levels.
DocetaxelDrug
Docetaxel will be administered as an IV infusion at planned dose levels.
CisplatinDrug
Cisplatin will be administered as an IV infusion at planned dose levels.
CetuximabDrug
Cetuximab will be administered as an IV infusion at planned dose levels.
| Study group | Role | What they receive |
|---|---|---|
| Regimen A: FT825 | Experimental | Participants with advanced HER2-expressing solid tumors receive FT825 following chemotherapy in Cycle 1 (each cycle is approximately 61 days). Based on the safety, tolerability, and radiographically confirmed clinical benefit to treatment in Cycle 1, participants may be considered for an additional treatment cycle (Cycle 2 retreatment). Receives: Drug: FT825; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Bendamustine; Drug: Docetaxel; Drug: Cisplatin |
| Regimen B: FT825 + Cetuximab | Experimental | Participants with advanced epidermal growth factor receptor (EGFR)-expressing solid tumors receive FT825 in combination with cetuximab following chemotherapy in Cycle 1 (each cycle is approximately 61 days). Based on the safety, tolerability, and radiographically confirmed clinical benefit to treatment in Cycle 1, participants may be considered for an additional treatment cycle (Cycle 2 retreatment). Receives: Drug: FT825; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Bendamustine; Drug: Docetaxel; Drug: Cisplatin; Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with dose limiting toxicities (DLTs)
The number of participants with DLTs will be reported.
Measured: Up to approximately 29 days
Number of participants with treatment-emergent adverse events (TEAEs)
The number of participants with TEAEs will be reported.
Measured: Up to approximately 2 years
Severity of AEs
Severity of AEs will be determined according to appropriate rating scales for the type of event reported.
Measured: Up to approximately 2 years
Secondary outcomes (5)
Investigator-Assessed Overall Response Rate (ORR)
ORR is the proportion of participants who achieve partial response (PR) or complete response (CR) per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST, v.1.1).
Measured: Up to approximately 2 years
Investigator-Assessed Duration of Response (DOR)
DOR is the duration from the first occurrence of a documented objective response of either PR or CR until the time of disease progression, or death from any cause, whichever occurs first, per RECIST, v.1.1.
Measured: Up to approximately 2 years
Progression-Free Survival (PFS)
PFS is the time from first dose of study intervention to disease progression, or to the day of death for any reason, whichever occurs first, per RECIST, v.1.1.
Measured: Up to approximately 2 years
Overall Survival (OS)
OS defined as the time from first dose of study intervention to death from any cause.
Measured: Up to approximately 2 years
Plasma Concentration of FT825
The plasma concentration of FT825 will be determined.
Measured: At designated time points up to approximately 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start5 Jan 2024
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2044 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 351 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fate Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Fate Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241456
- Sponsor's protocol ID
- FT825-101
- Status last verified
- Dec 2024
- First submitted
- 27 Jan 2024
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of FT825/ONO-8250, an Off-the-Shelf CAR T-Cell Therapy, With or Without Monoclonal Antibodies, in HER2-Positive or Other Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06241456
- Acronym / sponsor ID
- FT825-101
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 351 participants (estimated)
- Lead sponsor
- Fate TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 May 2044 (estimated)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regimen A: FT825 | Experimental | Drug: FT825, Drug: Fludarabine, Drug: Cyclophosphamide, Drug: Bendamustine, Drug: Docetaxel, Drug: CisplatinParticipants with advanced HER2-expressing solid tumors receive FT825 following chemotherapy in Cycle 1 (each cycle is approximately 61 days). Based on the safety, tolerability, and radiographically confirmed clinical benefit to treatment in Cycle 1, participants may be considered for an additional treatment cycle (Cycle 2 retreatment). |
| Regimen B: FT825 + Cetuximab | Experimental | Drug: FT825, Drug: Fludarabine, Drug: Cyclophosphamide, Drug: Bendamustine, Drug: Docetaxel, Drug: Cisplatin, Drug: CetuximabParticipants with advanced epidermal growth factor receptor (EGFR)-expressing solid tumors receive FT825 in combination with cetuximab following chemotherapy in Cycle 1 (each cycle is approximately 61 days). Based on the safety, tolerability, and radiographically confirmed clinical benefit to treatment in Cycle 1, participants may be considered for an additional treatment cycle (Cycle 2 retreatment). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histopathological or cytologically confirmed locally advanced or metastatic cancer that meets protocol-defined criteria
- Disease that is not amenable to curative therapy, with prior therapies defined by specific tumor types
- Contraceptive use by women and men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Presence of measurable disease by RECIST, v1.1 assessed within 28 days prior to start of first study intervention
Key exclusion criteria (11 listed)
- Females who are pregnant or breastfeeding
- Evidence of inadequate organ function
- Clinically significant cardiovascular disease
- Known active central nervous system (CNS) involvement by malignancy
- Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions within 2 years prior to study enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FT825Also: ONO-8250FT825 will be administered as an intravenous (IV) infusion at planned dose levels. | Drug | Regimen A: FT825, Regimen B: FT825 + Cetuximab |
| FludarabineAlso: FLUDARAFludarabine will be administered as an IV infusion at planned dose levels. | Drug | Regimen A: FT825, Regimen B: FT825 + Cetuximab |
| CyclophosphamideCyclophosphamide will be administered as an IV infusion at planned dose levels. | Drug | Regimen A: FT825, Regimen B: FT825 + Cetuximab |
| BendamustineBendamustine will be administered as an IV infusion at planned dose levels. | Drug | Regimen A: FT825, Regimen B: FT825 + Cetuximab |
| DocetaxelDocetaxel will be administered as an IV infusion at planned dose levels. | Drug | Regimen A: FT825, Regimen B: FT825 + Cetuximab |
| CisplatinCisplatin will be administered as an IV infusion at planned dose levels. | Drug | Regimen A: FT825, Regimen B: FT825 + Cetuximab |
| CetuximabCetuximab will be administered as an IV infusion at planned dose levels. | Drug | Regimen B: FT825 + Cetuximab |
Primary outcome
Number of participants with dose limiting toxicities (DLTs)
Time frame: Up to approximately 29 days
The number of participants with DLTs will be reported.
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: Up to approximately 2 years
The number of participants with TEAEs will be reported.
Severity of AEs
Time frame: Up to approximately 2 years
Severity of AEs will be determined according to appropriate rating scales for the type of event reported.
5 secondary outcomes
Investigator-Assessed Overall Response Rate (ORR)
Time frame: Up to approximately 2 years
Investigator-Assessed Duration of Response (DOR)
Time frame: Up to approximately 2 years
Progression-Free Survival (PFS)
Time frame: Up to approximately 2 years
Overall Survival (OS)
Time frame: Up to approximately 2 years
Plasma Concentration of FT825
Time frame: At designated time points up to approximately 56 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Director study director
Fate Therapeutics
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FT825, Fludarabine and Cyclophosphamide in people with Advanced Solid Tumor, run by Fate Therapeutics at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fate Trial Disclosure (858-875-1800, FateTrialDisclosure@fatetherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with dose limiting toxicities (DLTs) (time frame: Up to approximately 29 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.