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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 3 years
Awards & highlights
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
- Pancreatic Cancer
- Breast Cancer
- Non-Small Cell Lung Cancer
- Ovarian Cancer
- Gastroesophageal Cancer
- Colorectal Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years
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
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
Pembrolizumab
2017
Completed Phase 2
~2010
Cetuximab
2011
Completed Phase 3
~2480
Nivolumab
2014
Completed Phase 3
~4750
Atezolizumab
2017
Completed Phase 3
~5860
Trastuzumab
2014
Completed Phase 4
~5190
Cyclophosphamide
1995
Completed Phase 3
~3780
Fludarabine
2012
Completed Phase 3
~1100
IL-2
2007
Completed Phase 4
~1180
Find a Location
Who is running the clinical trial?
Fate TherapeuticsLead Sponsor
21 Previous Clinical Trials
1,796 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had any type of cancer, other than the ones being studied in this trial, within the past 2 years of starting the treatment.You have a brain or nervous system condition like stroke, epilepsy, or neurodegenerative disease, or you are taking medications for these conditions.You are currently taking or will need medication that weakens your immune system.You have been diagnosed with non-small cell lung cancer (NSCLC), colorectal cancer (CRC), breast cancer (BC), ovarian cancer, or pancreatic cancer.You are allergic to human albumin or dimethyl sulfoxide (DMSO).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.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.You have cancer in your brain or spinal cord that hasn't been stable for at least 3 months after treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort F/F2/FF/FF2: FT536 + Amivantamab
- Group 2: Cohort B/B2/BB/BB2: FT536 + Avelumab
- Group 3: Cohort E/E2/EE/EE2: FT536 + Cetuximab
- Group 4: Cohort A/A2/AA/AA2: FT536 Monotherapy
- Group 5: Cohort C/C2/CC/CC2: FT536 + Pembrolizumab, Nivolumab, or Atezolizumab
- Group 6: Cohort D/D2/DD/DD2: FT536 + Trastuzumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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