Non-Small Cell Lung CancerPhase 1NCT07216105
FT836 With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors
A Phase 1 study testing FT836, Cetuximab and Trastuzumab in people with Non-Small Cell Lung Cancer and Colorectal Cancer, run by Fate Therapeutics at 5 sites in United States.
Trial summary
This is a Phase 1 study of FT836 administered in participants with advanced solid tumors. The primary objectives of the study are to evaluate the safety and tolerability of FT836 with or without chemotherapy and/or trastuzumab or cetuximab, and to determine the recommended phase 2 dose (RP2D) of FT836 with or without… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Colorectal Cancer, Breast Cancer
- What is being tested?
- FT836, Cetuximab and Trastuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 5 sitesUnited States
- Study dates
- 4 Nov 2025to Jan 2030
- 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
- For all regimens, disease that is not amenable to curative therapy and that has relapsed or progressed following at least one line of prior systemic therapy.
- Evidence of adequate organ function as determined by all of the following:
- Absolute neutrophil count (ANC) >1000/µL without growth factor support within 7 days prior to start of first study intervention
- Platelet count ≥75,000/µL without transfusion support within 14 days prior to start of first study intervention
- Estimated creatinine clearance ≥50 mL/minute by Cockcroft-Gault method or other standard institutional method
- Total bilirubin ≤1.5 × upper limit of normal (ULN); for participants with documented Gilbert syndrome, total bilirubin must be ≤3 ×ULN
Show all 12Show fewer
- Aspartate transaminase (AST) ≤3 × ULN or alanine transaminase (ALT) ≤3 × ULN; in participants with documented liver metastases, AST or ALT ≤5 × ULN
- Alkaline phosphatase (ALP) ≤2.5 × ULN; in participants with documented liver or bone metastases, ALP ≤5 × ULN
- Oxygen saturation >90% on room air
- 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.
- Presence of baseline safely accessible lesions of adequate size for on-treatment biopsies (exceptions for lesion size may be granted with medical monitor approval) and participant willingness to undergo protocol prescribed on-treatment biopsies.
Who cannot join
- Clinically significant cardiovascular disease including any of the following: uncontrolled/ unstable cardiac arrhythmias, myocardial infarction within 6 months prior to start of first study intervention, unstable angina or congestive heart failure of New York Heart Association (NYHA) Grade 2 or higher, or cardiac ejection fraction <50%.
- Receipt of any biological therapy, chemotherapy, investigational therapy, or radiation therapy within 2 weeks or five half-lives prior to start of first study intervention, whichever is shorter.
- Known active central nervous system (CNS) involvement by malignancy. Participants with prior CNS involvement from their malignancy must have completed effective treatment of their CNS disease with no symptoms of disease in the absence of steroid treatment and at least stable findings on relevant CNS imaging and no evidence of leptomeningeal disease for at least 4 weeks prior to study enrollment.
- Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions within 6 months prior to study enrollment.
- Currently receiving or likely to require systemic immunosuppressive therapy (e.g., prednisone ≥5 mg daily) for any reason from start of first study intervention to Day 29 with the exception of corticosteroids as a premedication for chemotherapy side effects per institutional standard of care or as mandated by the protocol.
- 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.
- Grade ≥2 peripheral neuropathy limiting instrumental activities of daily living.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
M. D. Anderson Cancer Center
Houston, Texas, 77030
Principle Investigator
- Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, 92093
- Recruiting
University of Southern California
Los Angeles, California, 90033
- Recruiting
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, 55455
Principle Investigator
- Recruiting
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107
Principle Investigator
About this study
Official title: A Phase 1, Open-Label Study of FT836, an Off-the-Shelf CAR T-Cell Therapy, With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors
This is a Phase 1 study of FT836 administered in participants with advanced solid tumors. The primary objectives of the study are to evaluate the safety and tolerability of FT836 with or without chemotherapy and/or trastuzumab or cetuximab, and to determine the recommended phase 2 dose (RP2D) of FT836 with or without chemotherapy and/or trastuzumab or cetuximab
- Conditions
- Non-Small Cell Lung Cancer, Colorectal Cancer, Breast Cancer, Ovarian Cancer, Endometrial Carcinoma, Head and Neck Squamous Cell Carcinoma
- Being tested
- FT836, Cetuximab, Trastuzumab
- Keywords
- HNSCC, NSCLC, CRC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Breast Neoplasms, Ovarian Neoplasms, Endometrial Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FT836Drug
FT836 drug product is administered as an intravenous infusion on multiple days schedule at treatment cycle.
CetuximabDrug
Cetuximab administration will begin on Day -4 at the recommended initial dose of 400 mg/m2 as a 120-minute IV infusion
TrastuzumabDrug
Trastuzumab administration will begin on Day -4 at an initial dose of 4 mg/kg as a 90-minute IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Regimen A | Experimental | CY/FLU followed by FT836 Receives: Drug: FT836 |
| Regimen B | Experimental | Standard-of-care (SOC) chemotherapy followed by FT836 Receives: Drug: FT836 |
| Regimen C | Experimental | FT836 combined with cetuximab Receives: Drug: FT836; Drug: Cetuximab |
| Regimen D | Experimental | CY/FLU followed by FT836 combined with cetuximab Receives: Drug: FT836; Drug: Cetuximab |
| Regimen D1 | Experimental | SOC chemotherapy followed by FT836 combined with cetuximab Receives: Drug: FT836; Drug: Cetuximab |
| Regimen E | Experimental | FT836 combined with trastuzumab Receives: Drug: FT836; Drug: Trastuzumab |
| Regimen F | Experimental | CY/FLU followed by FT836 combined with trastuzumab Receives: Drug: FT836; Drug: Trastuzumab |
| Regimen F1 | Experimental | SOC chemotherapy followed by FT836 combined with trastuzumab Receives: Drug: FT836; Drug: Trastuzumab |
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 experiencing ≥1 DLT will be reported.
Measured: From Day 1 through Day 29 of Cycle 1( each cycle is 56 days)
Severity of DLTs
The severity of DLTs will be determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE, v5.0).
Measured: From Day 1 through Day 29 of Cycle 1( each cycle is 56 days)
Secondary outcomes (4)
Overall Response Rate (ORR)
Participants will be classified into the following tumor response categories: complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or not evaluable (NE) per RECIST v1.1. The best overall response (BOR) will be summarized for the efficacy evaluable population. ORR is defined as the percentage of participants who achieve a PR or better during the study prior to any subsequent off-protocol anti-cancer therapy.
Measured: Up to approximately 24 months
Duration of Response (DOR)
The DOR is defined as the time from first objective response to disease progression or death from any cause.
Measured: Up to approximately 24 months
Progression-Free Survival (PFS)
PFS is defined as the time from first study intervention to progressive disease or death from any cause.
Measured: Up to approximately 24 months
Overall Survival (OS)
OS is defined as the time from first dose of study intervention to death from any cause.
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2025
- Study start4 Nov 2025
- Primary completionJan 2028 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 119 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fate Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lilly Wong, PhD, Study director, Fate Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216105
- Sponsor's protocol ID
- FT836-101
- Status last verified
- Aug 2026
- First submitted
- 8 Oct 2025
- Last updated
- 2 Sep 2026
- 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 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study of FT836, an Off-the-Shelf CAR T-Cell Therapy, With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07216105
- Acronym / sponsor ID
- FT836-101
- Conditions
- Non-Small Cell Lung Cancer, Colorectal Cancer, Breast Cancer, Ovarian Cancer, Endometrial Carcinoma, Head and Neck Squamous Cell Carcinoma
- Keywords
- HNSCC, NSCLC, CRC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 119 participants (estimated)
- Lead sponsor
- Fate TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 14 Oct 2025 (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 of FT836 administered in participants with advanced solid tumors. The primary objectives of the study are to evaluate the safety and tolerability of FT836 with or without chemotherapy and/or trastuzumab or cetuximab, and to determine the recommended phase 2 dose (RP2D) of FT836 with or without chemotherapy and/or trastuzumab or cetuximab
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Regimen A | Experimental | Drug: FT836CY/FLU followed by FT836 |
| Regimen B | Experimental | Drug: FT836Standard-of-care (SOC) chemotherapy followed by FT836 |
| Regimen C | Experimental | Drug: FT836, Drug: CetuximabFT836 combined with cetuximab |
| Regimen D | Experimental | Drug: FT836, Drug: CetuximabCY/FLU followed by FT836 combined with cetuximab |
| Regimen D1 | Experimental | Drug: FT836, Drug: CetuximabSOC chemotherapy followed by FT836 combined with cetuximab |
| Regimen E | Experimental | Drug: FT836, Drug: TrastuzumabFT836 combined with trastuzumab |
| Regimen F | Experimental | Drug: FT836, Drug: TrastuzumabCY/FLU followed by FT836 combined with trastuzumab |
| Regimen F1 | Experimental | Drug: FT836, Drug: TrastuzumabSOC chemotherapy followed by FT836 combined with trastuzumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- For all regimens, disease that is not amenable to curative therapy and that has relapsed or progressed following at least one line of prior systemic therapy.
- Evidence of adequate organ function as determined by all of the following:
- 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.
- Presence of baseline safely accessible lesions of adequate size for on-treatment biopsies (exceptions for lesion size may be granted with medical monitor approval) and participant willingness to undergo protocol prescribed on-treatment biopsies.
Key exclusion criteria (7 listed)
- Clinically significant cardiovascular disease including any of the following: uncontrolled/ unstable cardiac arrhythmias, myocardial infarction within 6 months prior to start of first study intervention, unstable angina or congestive heart failure of New York Heart Association (NYHA) Grade 2 or higher, or cardiac ejection fraction <50%.
- Receipt of any biological therapy, chemotherapy, investigational therapy, or radiation therapy within 2 weeks or five half-lives prior to start of first study intervention, whichever is shorter.
- Known active central nervous system (CNS) involvement by malignancy. Participants with prior CNS involvement from their malignancy must have completed effective treatment of their CNS disease with no symptoms of disease in the absence of steroid treatment and at least stable findings on relevant CNS imaging and no evidence of leptomeningeal disease for at least 4 weeks prior to study enrollment.
- Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions within 6 months prior to study enrollment.
- Currently receiving or likely to require systemic immunosuppressive therapy (e.g., prednisone ≥5 mg daily) for any reason from start of first study intervention to Day 29 with the exception of corticosteroids as a premedication for chemotherapy side effects per institutional standard of care or as mandated by the protocol.
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 |
|---|---|---|
| FT836FT836 drug product is administered as an intravenous infusion on multiple days schedule at treatment cycle. | Drug | Regimen A, Regimen B, Regimen C, Regimen D, Regimen D1, Regimen E, Regimen F, Regimen F1 |
| CetuximabCetuximab administration will begin on Day -4 at the recommended initial dose of 400 mg/m2 as a 120-minute IV infusion | Drug | Regimen C, Regimen D, Regimen D1 |
| TrastuzumabTrastuzumab administration will begin on Day -4 at an initial dose of 4 mg/kg as a 90-minute IV infusion. | Drug | Regimen E, Regimen F, Regimen F1 |
Primary outcome
Number of participants with dose limiting toxicities (DLTs)
Time frame: From Day 1 through Day 29 of Cycle 1( each cycle is 56 days)
The number of participants experiencing ≥1 DLT will be reported.
Severity of DLTs
Time frame: From Day 1 through Day 29 of Cycle 1( each cycle is 56 days)
The severity of DLTs will be determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE, v5.0).
4 secondary outcomes
Overall Response Rate (ORR)
Time frame: Up to approximately 24 months
Duration of Response (DOR)
Time frame: Up to approximately 24 months
Progression-Free Survival (PFS)
Time frame: Up to approximately 24 months
Overall Survival (OS)
Time frame: Up to approximately 24 months
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 2 Sep 2026.
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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.
Lilly Wong, PhD study director
Fate Therapeutics, Inc.
5 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 FT836, Cetuximab and Trastuzumab in people with Non-Small Cell Lung Cancer and Colorectal Cancer, run by Fate Therapeutics at 5 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 12 inclusion and 7 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 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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: From Day 1 through Day 29 of Cycle 1( each cycle is 56 days)). The study lists 2 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 2 Sep 2026.