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 location...
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
Contact Information
Primary
Fate Trial Disclosure
FateTrialDisclosure@fatetherapeutics.com
866-875-1800
Backup
Brian Dempster
brian.dempster@fatetherapeutics.com
Time Frame
Start Date: 2025-10-30
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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