Actively Recruiting
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
Led by Fate Therapeutics · Updated on 2026-04-07
113
Participants Needed
5
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating FT836, an off-the-shelf CAR T-cell therapy, in adults with advanced solid tumors that have relapsed or progressed after prior systemic treatment. This phase 1 study aims to assess the safety and tolerability of FT836 given alone or combined with paclitaxel chemotherapy and/or monoclonal antibodies cetuximab or trastuzumab. The study also seeks to determine the recommended dose for future phases when FT836 is combined with these antibodies, with or without paclitaxel. Participants are assigned to one of six treatment groups: FT836 alone; paclitaxel followed by FT836; FT836 combined with cetuximab; paclitaxel followed by FT836 plus cetuximab; FT836 combined with trastuzumab; or paclitaxel followed by FT836 plus trastuzumab. FT836 is given by intravenous infusion on multiple days within each 56-day treatment cycle. Paclitaxel is administered weekly before FT836 on days -21, -14, and -7. Cetuximab and trastuzumab start on day -4 with specified infusion doses and durations. Participants undergo assessments to monitor safety, including dose limiting toxicities during the first 29 days of treatment cycles. Researchers also track tumor response, progression-free survival, and overall survival for up to about 24 months. Study visits include physical exams, laboratory tests, imaging scans, and biopsies if safe and feasible. The study is open-label and non-randomized, with participants followed closely throughout treatment and long-term monitoring.
CONDITIONS
Brief Title
FT836 With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Have advanced solid tumors not suitable for curative treatment that have relapsed or progressed after at least one prior systemic therapy
- Adequate organ function including neutrophil count over 1000/µL, platelets over 75,000/µL, creatinine clearance over 50 mL/min, and acceptable liver function tests
- Oxygen saturation above 90% on room air
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Measurable disease by RECIST v1.1 within 28 days prior to treatment
- Presence of safely accessible lesions for biopsies and willingness to undergo biopsies during treatment
You will not qualify if you...
- Clinically significant cardiovascular disease such as unstable arrhythmias, recent heart attack within 6 months, unstable angina, congestive heart failure NYHA grade 2 or higher, or ejection fraction below 50%
- Receiving or recently received biological therapy, chemotherapy, investigational therapy, or radiation within 2 weeks or five half-lives before treatment
- Active central nervous system (CNS) cancer involvement or recent CNS disease requiring steroids
- Non-cancer CNS diseases like stroke, epilepsy, or neurodegenerative conditions within past 6 months
- Receiving systemic immunosuppressive therapy (e.g., prednisone over 5 mg daily) during the first 29 days, except corticosteroids for chemotherapy side effects
- History of severe immune-related adverse events or significant eye toxicity from prior cancer immunotherapy
- Peripheral neuropathy grade 2 or higher limiting daily activities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 weeks
Participants receive chemotherapy with Paclitaxel weekly on Days -21, -14, and -7 before starting FT836 treatment in applicable regimens.
3 visits (in-person, weekly)
Duration - 1 day
Participants receive an initial dose of Cetuximab or Trastuzumab on Day -4 prior to FT836 treatment in applicable regimens.
1 visit (in-person)
Duration - Repeated 56-day cycles until disease progression or discontinuation
Participants receive FT836 drug product as intravenous infusion on multiple days in treatment cycles of 56 days. Some participants receive FT836 alone or combined with chemotherapy and/or monoclonal antibodies depending on their assigned regimen.
Multiple visits for infusions during each cycle
Duration - Up to approximately 24 months
Participants are monitored for safety and treatment response after completion or discontinuation of treatment for up to approximately 24 months.
Periodic visits for assessments
Trial Site Locations
Total: 5 locations
1
University of Southern California
La Jolla, California, United States, 90033
Actively Recruiting
2
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
3
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
4
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
5
M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
F
Fate Trial Disclosure
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here