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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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 paclitaxel and/or trastuzumab or cetuximab, and to determine the recommended phase 2 dose (RP2D) of FT836 in combination with trastuzumab or cetuximab; each objective will be assessed with or without paclitaxel chemotherapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Minnesota
University of Minnesota Masonic Cancer Center
RECRUITING
Minneapolis
Pennsylvania
Thomas Jefferson University, Sidney Kimmel Cancer Center
RECRUITING
Philadelphia
Texas
M. D. Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Fate Trial Disclosure
FateTrialDisclosure@fatetherapeutics.com
858-875-1800
Time Frame
Start Date: 2025-11-04
Estimated Completion Date: 2030-01
Participants
Target number of participants: 113
Treatments
Experimental: Regimen A ( FT836)
Participants receive FT836 monotherapy
Experimental: Regimen B ( Paclitaxel + FT836)
Participants receive Paclitaxel chemotherapy followed by FT836
Experimental: Regimen C ( Cetuximab + FT836)
Participants receive FT836 combined with cetuximab
Experimental: Regimen D ( Paclitaxel + Cetuximab + FT836)
Participants receive Paclitaxel chemotherapy followed by FT836 combined with cetuximab
Experimental: Regimen E ( Trastuzumab + FT836))
Participants receive FT836 combined with trastuzumab
Experimental: Regimen F ( Paclitaxel + Trastuzumab + FT836)
Participants receive Paclitaxel chemotherapy followed by FT836 combined with trastuzumab
Sponsors
Leads: Fate Therapeutics

This content was sourced from clinicaltrials.gov

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