FT836 alone or with chemotherapy and antibody drugs for advanced solid tumors.
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 trial will test if FT836, given alone or with paclitaxel and/or the antibodies trastuzumab or cetuximab, is safe and tolerable for people with advanced solid tumors who have already received prior treatment.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 113 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fate Therapeutics Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, prednisone, trastuzumab, cetuximab |
| Locations | 5 sites (La Jolla, California and 4 other locations) |
| Trial ID | NCT07216105 on ClinicalTrials.gov |
What this trial studies
This is a phase 1, dose-finding trial that gives FT836 either by itself or combined with paclitaxel and/or monoclonal antibodies (trastuzumab or cetuximab) to people with advanced solid tumors. The study enrolls participants with cancers such as non-small cell lung, colorectal, breast, ovarian, or endometrial carcinoma that have progressed after prior systemic therapy. Researchers will escalate doses to determine safety, tolerability, and a recommended phase 2 dose for the combinations, monitoring labs, adverse events, and clinical response. Each combination will be evaluated with and without paclitaxel to understand how adding chemotherapy affects safety and dosing.
Who should consider this trial
Good fit: Ideal candidates are adults with advanced non-small cell lung, colorectal, breast, ovarian, or endometrial cancers that have relapsed or progressed after at least one line of systemic therapy and who meet required organ function and lab criteria.
Not a fit: Patients with cancers still amenable to curative therapy, those with poor organ function or uncontrolled medical conditions, or people unable to travel to a study site are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, FT836 could offer a new treatment option for some patients with advanced solid tumors, potentially improving disease control when combined with chemotherapy or targeted antibodies.
How similar studies have performed: While cellular immunotherapies have transformed treatment for some blood cancers, they have shown limited and inconsistent success in solid tumors, so combining FT836 with chemo or monoclonal antibodies represents a relatively novel and unproven approach in this setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * 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. Exclusion Criteria: * 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 fifirst 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.
Where this trial is running
La Jolla, California and 4 other locations
- University of Southern California — La Jolla, California, United States (Recruiting)
- UC San Diego Moores Cancer Center — La Jolla, California, United States (Recruiting)
- University of Minnesota Masonic Cancer Center — Minneapolis, Minnesota, United States (Recruiting)
- Thomas Jefferson University, Sidney Kimmel Cancer Center — Philadelphia, Pennsylvania, United States (Recruiting)
- M. D. Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Fate Trial Disclosure
- Email: FateTrialDisclosure@fatetherapeutics.com
- Phone: 858-875-1800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.