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This study was terminated by the Sponsor.
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This is a Phase 1 dose-finding study of FT536 given in combination with a monoclonal antibody following lymphodepletion in participants with advanced solid tumors. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A/A2/AA/AA2: FT536 Monotherapy | Experimental | 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. |
|
| Cohort B/B2/BB/BB2: FT536 + Avelumab | Experimental | FT536 + avelumab combination therapy in participants with locally advanced or metastatic solid tumor indications with documented PD-L1 expression. |
|
| Cohort C/C2/CC/CC2: FT536 + Pembrolizumab, Nivolumab, or Atezolizumab | Experimental | FT536 + pembrolizumab, nivolumab, or atezolizumab in participants with locally advanced or metastatic solid tumor indications with documented PD-L1 expression. |
|
| Cohort D/D2/DD/DD2: FT536 + Trastuzumab | Experimental | FT536 + trastuzumab in participants with locally advanced or metastatic documented human epidermal growth factor receptor 2 (HER2+) expressing tumors |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FT536 | Drug | FT536 is an allogeneic natural killer (NK)-cell immunotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the Recommended Phase 2 Dose (RP2D) | The RP2Ds of FT536 monotherapy and FT536 + monoclonal antibody (mAbs) will be determined. The RP2D will be determined based on the overall safety and efficacy profile. | Up to approximately 3 years |
| Number of Participants with ≥ Adverse Event (AE) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v5.0 | The safety and tolerability of FT536 monotherapy and in combination with mAbs will be determined. | Following enrollment completion within dose escalation and expansion, approximately 3 years |
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Inclusion Criteria:
Cohort A/A2/AA/AA2: NSCLC, CRC, BC, ovarian cancer, or pancreatic cancer
Cohorts B/B2/BB/BB2 and C/C2/CC/CC2: Subjects with NSCLC, HNSCC, gastroesophageal adenocarinoma, triple negative breast cancer, or urothelial carcinoma whose tumors express PD-L1 according to defined cutoff
Cohort D/D2/DD/DD2: Subjects with advanced solid tumor whose tumor(s) express HER2 defined as: ≥2+ by IHC, Average HER2 copy number ≥4 signals per cell by in situ hybridization or ≥4 copies as determined by next generation sequencing
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
Cohort F/F2/FF/FF2: NSCLC known to have at least one of the following: epidermal growth factor receptor (EGFR) driver mutation(s) and have progressed on or were intolerant to at least one prior line of EGFR Tyrosine Kinase Inhibitor (TKI) or were not candidates for or declined TKI; mesenchymal-epithelial transition (MET) exon 14 skipping mutation that has progressed on or intolerant of at least one prior line of MET TKI or were not candidates for or declined TKI; MET amplification defined as MET/CEP7 ratio ≥1.8 by Fluorescence in situ hybridization (FISH)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fate Trial Disclosure | Fate Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Honor Health Research Institute | Scottsdale | Arizona | 85258 | United States | ||
| UCLA Division of Hematology-Oncology |
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| Cohort E/E2/EE/EE2: FT536 + Cetuximab | Experimental | FT536 + cetuximab in participants with locally advanced or metastatic squamous NSCLC, CRC, or head and neck cancer. |
|
| Cohort F/F2/FF/FF2: FT536 + Amivantamab | Experimental | FT536 + amivantamab in participants with locally advanced or metastatic NSCLC. |
|
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| Cyclophosphamide | Drug | Lympho-conditioning agent |
|
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| Fludarabine | Drug | Lympho-conditioning agent |
|
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| IL-2 | Drug | For Cohort AA ONLY: To be combined with FT536 at the MTD or MAD |
|
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| Avelumab | Combination Product | Monoclonal antibody |
|
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| Pembrolizumab | Combination Product | For Cohorts C/CC, the combination product (monoclonal antibody) will be ONE of the following: pembrolizumab, nivolumab, or atezolizumab. |
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| Nivolumab | Combination Product | For Cohorts C/CC, the combination product (monoclonal antibody) will be ONE of the following: pembrolizumab, nivolumab, or atezolizumab. |
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| Atezolizumab | Combination Product | For Cohorts C/CC, the combination product (monoclonal antibody) will be ONE of the following: pembrolizumab, nivolumab, or atezolizumab. |
|
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| Trastuzumab | Combination Product | Monoclonal antibody |
|
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| Cetuximab | Combination Product | Monoclonal antibody |
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| Amivantamab | Combination Product | Monoclonal antibody |
|
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| IL-2 | Drug | For Cohorts BB-FF ONLY: To be combined with FT536 + mAb at the MTD or MAD |
|
|
| Los Angeles |
| California |
| 90404 |
| United States |
| Hackensack University Medical Center - John Theurer Cancer Center | Hackensack | New Jersey | 07601 | United States |
| Carolina BioOncology Institute | Huntersville | North Carolina | 28078 | United States |
| NEXT Oncology | San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D015179 | Colorectal Neoplasms |
| D001943 | Breast Neoplasms |
| D010051 | Ovarian Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D010182 | Pancreatic Diseases |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| D007252 | Influenza Vaccines |
| D007376 | Interleukin-2 |
| C000609138 | avelumab |
| C582435 | pembrolizumab |
| D000077594 | Nivolumab |
| C000594389 | atezolizumab |
| D000068878 | Trastuzumab |
| D000068818 | Cetuximab |
| C000718215 | amivantamab |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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