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CAR T-cell Therapy
FT536 for Non-Small Cell Lung Cancer
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
No Placebo-Only Group
Summary
This trial tests a new treatment using special immune cells and targeted protein therapy for patients with advanced solid tumors. The treatment aims to help the immune system attack cancer more effectively.
Eligible Conditions
- Breast Cancer
- Head and Neck Cancers
- Non-Small Cell Lung Cancer
- Esophageal cancer
- Pancreatic Cancer
- Ovarian 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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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
2017
Completed Phase 2
~2440
Pembrolizumab
2017
Completed Phase 3
~3150
Cetuximab
2011
Completed Phase 3
~2480
Nivolumab
2015
Completed Phase 3
~4010
Atezolizumab
2016
Completed Phase 3
~5860
Trastuzumab
2014
Completed Phase 4
~5190
Cyclophosphamide
2010
Completed Phase 4
~2310
Fludarabine
2012
Completed Phase 4
~1860
IL-2
2007
Completed Phase 4
~1100
Find a Location
Who is running the clinical trial?
Fate TherapeuticsLead Sponsor
21 Previous Clinical Trials
1,193 Total Patients Enrolled
Fate Trial DisclosureStudy DirectorFate Therapeutics
10 Previous Clinical Trials
382 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 C/C2/CC/CC2: FT536 + Pembrolizumab, Nivolumab, or Atezolizumab
- Group 3: Cohort D/D2/DD/DD2: FT536 + Trastuzumab
- Group 4: Cohort E/E2/EE/EE2: FT536 + Cetuximab
- Group 5: Cohort A/A2/AA/AA2: FT536 Monotherapy
- Group 6: Cohort B/B2/BB/BB2: FT536 + Avelumab
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.
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