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CAR T-cell Therapy

FT536 for Head and Neck Cancers

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
For subjects with >1 measurable lesion by RECIST v1.1 that can be safely accessed, willingness to undergo tumor biopsy
Cohort E/E2/EE/EE2: Squamous NSCLC; head and neck cancer that relapsed or progressed following prior cetuximab treatment; CRC subjects who are KRAS/NRAS/BRAF wild-type are required to have progressed/relapsed on prior cetuximab or panitumumab
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing a new cancer drug to see what dose is effective and if it works better with other existing cancer drugs.

Eligible Conditions
  • Head and Neck Cancers
  • Ovarian Cancer
  • Pancreatic Cancer
  • Breast Cancer
  • Non-Small Cell Lung Cancer
  • Gastroesophageal Cancer
  • Colorectal Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
If you have more than one tumor that can be seen and measured, you agree to have a small piece of tissue taken for testing.
Select...
You have a specific type of lung cancer or head and neck cancer that came back or got worse after being treated with cetuximab before. If you have colorectal cancer and your genes called KRAS, NRAS, and BRAF are normal, you need to have gotten worse or had your cancer come back after receiving cetuximab or panitumumab before.
Select...
You have been diagnosed with non-small cell lung cancer (NSCLC), colorectal cancer (CRC), breast cancer (BC), ovarian cancer, or pancreatic cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 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
Determine the Recommended Phase 2 Dose (RP2D)
Number of Participants with ≥ Adverse Event (AE) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v5.0

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups
Experimental Treatment
Group I: Cohort F/F2/FF/FF2: FT536 + AmivantamabExperimental Treatment5 Interventions
FT536 + amivantamab in participants with locally advanced or metastatic NSCLC.
Group II: Cohort E/E2/EE/EE2: FT536 + CetuximabExperimental Treatment5 Interventions
FT536 + cetuximab in participants with locally advanced or metastatic squamous NSCLC, CRC, or head and neck cancer.
Group III: Cohort D/D2/DD/DD2: FT536 + TrastuzumabExperimental Treatment5 Interventions
FT536 + trastuzumab in participants with locally advanced or metastatic documented human epidermal growth factor receptor 2 (HER2+) expressing tumors
Group IV: Cohort C/C2/CC/CC2: FT536 + Pembrolizumab, Nivolumab, or AtezolizumabExperimental Treatment7 Interventions
FT536 + pembrolizumab, nivolumab, or atezolizumab in participants with locally advanced or metastatic solid tumor indications with documented PD-L1 expression.
Group V: Cohort B/B2/BB/BB2: FT536 + AvelumabExperimental Treatment5 Interventions
FT536 + avelumab combination therapy in participants with locally advanced or metastatic solid tumor indications with documented PD-L1 expression.
Group VI: Cohort A/A2/AA/AA2: FT536 MonotherapyExperimental Treatment4 Interventions
FT536 monotherapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC), colorectal cancer (CRC), breast cancer (BC), ovarian cancer, or pancreatic cancer.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
2018
Completed Phase 2
~2450
Cetuximab
2011
Completed Phase 3
~2480
Pembrolizumab
2017
Completed Phase 3
~2050
Nivolumab
2014
Completed Phase 3
~4800
Atezolizumab
2016
Completed Phase 3
~6040
Trastuzumab
2014
Completed Phase 4
~8090
Amivantamab
2021
Completed Phase 2
~70
Cyclophosphamide
1995
Completed Phase 3
~3780
Fludarabine
2012
Completed Phase 3
~1090
IL-2
2007
Completed Phase 4
~1180

Find a Location

Who is running the clinical trial?

Fate TherapeuticsLead Sponsor
20 Previous Clinical Trials
1,764 Total Patients Enrolled
Fate Trial DisclosureStudy DirectorFate Therapeutics
10 Previous Clinical Trials
861 Total Patients Enrolled
Jeff Chou, MDStudy DirectorFate Therapeutics
4 Previous Clinical Trials
113 Total Patients Enrolled

Media Library

FT536 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05395052 — Phase 1
Head and Neck Cancers Research Study Groups: Cohort A/A2/AA/AA2: FT536 Monotherapy, Cohort B/B2/BB/BB2: FT536 + Avelumab, Cohort C/C2/CC/CC2: FT536 + Pembrolizumab, Nivolumab, or Atezolizumab, Cohort D/D2/DD/DD2: FT536 + Trastuzumab, Cohort E/E2/EE/EE2: FT536 + Cetuximab, Cohort F/F2/FF/FF2: FT536 + Amivantamab
Head and Neck Cancers Clinical Trial 2023: FT536 Highlights & Side Effects. Trial Name: NCT05395052 — Phase 1
FT536 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05395052 — Phase 1

Frequently Asked Questions

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

Has FT536 attained the authorization of the FDA?

"Due to the limited amount of information surrounding FT536's efficacy and safety, our team at Power estimated its risk level to be a 1 on a scale from 1-3."

Answered by AI

What is the cap on participants for this clinical research?

"Affirmative. Clinicaltrials.gov documents demonstrate that this clinical trial commenced on May 31st 2022 and was recently modified on June 21st 2022; seeking 322 participants from a single research centre."

Answered by AI

Does this investigation still admit new participants?

"Clinicaltrials.gov reveals that this study, which began recruitment on May 31st 2022 and was last updated June 21st 2022, is currently seeking suitable participants."

Answered by AI
~2 spots leftby Feb 2025