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CAR T-cell Therapy

FT538 for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by Fate Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~1.5 years
Awards & highlights

Study Summary

This trial is testing a new cancer drug to see what dose is safe and effective.

Eligible Conditions
  • Solid Tumors, Adult

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~1.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~1.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Define the Recommended Phase 2 Dose (RP2D)
Incidence and Severity of Adverse Events (AEs)0

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose ExpansionExperimental Treatment4 Interventions
Cohort A, Arm 1: FT538 plus avelumab in subjects with advanced solid tumors malignancies where anti-PD-1/PD-L1 antibodies are approved (except urothelial carcinoma (UC)) Cohort A, Arm 2: FT538 plus an anti-PD-1 antibody (nivolumab or pembrolizumab) in subjects with solid tumor malignancies where anti-PD-1/PD-L1 antibodies are approved (except UC) Cohort B, Arm 1: FT538 plus trastuzumab in subjects with HER2+ tumors Cohort C, Arm 1: FT538 plus cetuximab in subjects with advanced CRC or HNSCC Subjects with UC may be enrolled in the randomized expansion cohorts as follows: Cohort A, Arm R1: FT538 plus avelumab Cohort A, Arm R2: FT538 plus atezolizumab
Group II: Dose EscalationExperimental Treatment4 Interventions
Cohort A: FT538 plus avelumab in subjects with advanced solid tumors malignancies where anti-PD-1/PD-L1 antibodies are approved Cohort B: FT538 plus trastuzumab in subjects with advanced documented HER2+ tumors Cohort C: FT538 plus cetuximab in subjects with advanced colorectal cancer (CRC) or head and neck squamous cell carcinoma (HNSCC)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
Cyclophosphamide
1995
Completed Phase 3
~3780

Find a Location

Who is running the clinical trial?

Fate TherapeuticsLead Sponsor
21 Previous Clinical Trials
1,785 Total Patients Enrolled
Fate Trial DisclosureStudy DirectorFate Therapeutics
10 Previous Clinical Trials
850 Total Patients Enrolled
Brandon BeagleStudy DirectorFate Therapeutics
1 Previous Clinical Trials
5 Total Patients Enrolled

Media Library

FT538 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05069935 — Phase 1
Solid Tumors Research Study Groups: Dose Expansion, Dose Escalation
Solid Tumors Clinical Trial 2023: FT538 Highlights & Side Effects. Trial Name: NCT05069935 — Phase 1
FT538 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05069935 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has FT538 been granted authorization by the FDA?

"Due to the limited data regarding FT538's safety and efficacy, it was given a provisional score of 1."

Answered by AI

Is this research endeavor looking for new participants?

"This clinical research project is actively searching for participants. It was initially posted on October 15th 2021 and edited as recently as April 14th 2022, indicated by data from clinicaltrials.gov."

Answered by AI

How is FT538 typically employed to help patients?

"FT538 is mainly used for multiple sclerosis, yet it can also be employed to manage a spectrum of diseases including myelocytic leukemia, acute lymphoma, and retinoblastoma."

Answered by AI

Could you delineate any previous experiments using FT538?

"Currently, there are 889 ongoing studies for FT538 with 161 trials in their late-stage. Most of the clinical research is conducted out of Philadelphia, Pennsylvania but it's being trialed at 28446 separate sites worldwide."

Answered by AI

How many individuals have the capacity to sign up for this medical experiment?

"This trial requires 189 qualified individuals to take part and is being held at two different sites: Sarah Cannon in Nashville, Tennessee and Hackensack University Medical Center in Hackensack, New jersey."

Answered by AI

How many healthcare facilities have been authorized to administer this experiment?

"To date, Sarah Cannon (Nashville), Hackensack University Medical Center (Hackensack) and NEXT Oncology (San Antonio) are the only 4 medical sites taking part in this study; there could be more to come."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
FT538 in Combination With Monoclonal Antibodies in Advanced Solid Tumors
2021. "FT538 in Combination With Monoclonal Antibodies in Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05069935.
~5 spots leftby Apr 2025
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