Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Digestive System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Gland and Hormone Related Diseases

Blood and Lymph Conditions

Immune System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Infections

Rare Diseases

Breast Neoplasms

Stomach Neoplasms

Carcinoma

Carcinoma, Squamous Cell

Lung Neoplasms

Small Cell Lung Carcinoma

Carcinoma, Hepatocellular

Pancreatic Neoplasms

Lymphoma

Uterine Cervical Neoplasms

Melanoma

Carcinoma, Renal Cell

Head and Neck Neoplasms

Microsatellite Instability

Carcinoma, Transitional Cell

Carcinoma, Merkel Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Adenocarcinoma

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Neoplasms

Urologic Neoplasms

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Communicable Diseases

Polyomavirus Infections

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Carcinoma, Neuroendocrine

Genomic Instability

Stomach Cancer

Small Cell Lung Cancer

Pancreatic Cancer

Lymphosarcoma

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Transitional Cell Carcinoma

Merkel Cell Carcinoma

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Dermatologic Agents

Immunomodulating Agents

Coal Tar

Long Term follow-up of subjects who have received an allogeneic, iPSC-derived NK cell in a previous trial.

No study drug is administered in this study. Subjects who received an allogeneic, iPSC-derived NK cell in a previous trial will be evaluated in this trial for long-term safety and efficacy

Allogeneic natural killer (NK) cell

Fate Trial Disclosure

Subjects who previously took part in the FT500-101 study and received allogeneic NK cell immunotherapy will take part in this long term follow-up study. Subjects will automatically enroll into study FT-003 once they have withdrawn or complete the parent interventional study.

The purpose of this study is to provide long-term safety and survival data for subjects who have participated in the parent study. No additional study drug will be given, but subjects can receive other therapies for their cancer while they are being followed for long term safety in this study.

This is a multicenter, non-interventional, observation study designed to provide long-term safety and efficacy data on subjects who have participated in a prior Fate Therapeutics interventional study of FT500 cellular immunotherapy. Subjects will be contacted every six months (± one month), beginning six months after subject completion or withdrawal from the FT500-101 study.

Long-term, Non-interventional, Observational Study Following Treatment With Fate Therapeutics FT500 Cellular Immunotherapy

OS defined as the interval between the date of the first NK cell infusion and the date of death due to any cause

Fate Therapeutics

Carcinoma, Non-Small-Cell Lung

Colorectal Neoplasms

Squamous Cell Carcinoma of Head and Neck

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplasms, Squamous Cell

Stomach Diseases

Antineoplastic Agents

Trastuzumab

Antibodies

Antibodies, Monoclonal

Cetuximab

Immunoglobulins

Mitogens

Antineoplastic Agents, Immunological

FATE-NK100 as a monotherapy in subjects with advanced solid tumor malignancies.

FATE-NK100 in combination with trastuzumab in subjects with human epidermal growth factor receptor 2 positive (HER2+) advanced breast cancer, HER2+ advanced gastric cancer or other advanced HER2+ solid tumors.

Regimen C: FATE-NK100 in combination with cetuximab in subjects with advanced colorectal cancer (CRC) or head and neck squamous cell cancer (HNSCC), or other epidermal growth factor receptor 1 positive (EGFR1+) advanced solid tumors.

FATE-NK100 is a donor-derived NK cell product comprised of ex vivo activated effector cells with enhanced anti-tumor activity

FATE-NK100

Epidermal growth factor receptor inhibitor antineoplastic agent

Jeff Chou, MD

This is a Phase 1, single-dose, open-label, dose-escalation study. The study will be conducted in three parts (i.e. regimens) in an outpatient setting as follows:

* Regimen A: FATE-NK100 as a monotherapy in subjects with advanced solid tumor malignancies.
* Regimen B: FATE-NK100 in combination with trastuzumab in subjects with human epidermal growth factor receptor 2 positive (HER2+) advanced breast cancer, HER2+ advanced gastric cancer or other advanced HER2+ solid tumors.
* Regimen C: FATE-NK100 in combination with cetuximab in subjects with advanced colorectal cancer (CRC) or head and neck squamous cell cancer (HNSCC), or other epidermal growth factor receptor 1 positive (EGFR1+) advanced solid tumors.

FATE-NK100 as Monotherapy and in Combination With Monoclonal Antibody in Subjects With Advanced Solid Tumors

The incidence of dose-limiting toxicity (DLT) within each dose cohort within the first 28 days after FATE-NK100 administration (ie, Day 1 through Day 29).

Objective-response rate (ORR): defined as the proportion of patients who achieve partial response (PR) or complete response (CR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at any time on study.

The PK of FATE-NK100, as assessed by the proportion of lymphocytes in peripheral blood that are of donor/product origin at the specified time points.

Skin Diseases

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Antirheumatic Agents

Anti-Infective Agents

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Immune Checkpoint Inhibitors

Pembrolizumab

Aldesleukin

Nivolumab

Atezolizumab

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

FT500 administered once weekly for 3 weeks as a monotherapy

FT500 administered once weekly for 3 weeks in combination with one of the following immune checkpoint inhibitors: nivolumab, pembrolizumab or atezolizumab.

FT500 + IL-2 administered once weekly for 3 weeks in combination with one of the following immune checkpoint inhibitors: nivolumab, pembrolizumab or atezolizumab.

FT500 is an allogeneic, iPSC-derived Natural Killer (NK) cell cancer immunotherapy

FT500

IL-2

FT500 is an off-the-shelf, iPSC-derived NK cell product that can bridge innate and adaptive immunity, and has the potential to overcome multiple mechanisms of immune checkpoint inhibitor (ICI) resistance. The preclinical data provide compelling evidence supporting the clinical investigation of FT500 as monotherapy and in combination with ICI in participants with advanced solid tumors.

FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors

FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors (Phase 1)

The incidence of participants with DLTs within each assessed dose level cohort to determine the maximum tolerated dose (MTD) or maximum assessed dose (MAD).

ORR is defined as the proportion of participants who achieve immune partial reponse/partial response (iPR/PR) or immune complete response/complete response (iCR/CR). Tumor response will be assessed using modified Response Evaluation Criteria in Solid Tumors (iRECIST) or Response Evaluation Criteria in Lymphoma (RECIL), as applicable.

Duration of FT500 response is defined as duration from Day 1 to undetectable levels of FT500 cells per uL blood.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Long-term, Non-interventional, Observational Study Following Treatment With Fate Therapeutics FT500 Cellular Immunotherapy	NCT04106167	Advanced Solid ... Lymphoma Gastric Cancer Colorectal Canc... Head and Neck C... Squamous Cell C... EGFR Positive S... HER2-positive B... Hepatocellular ... Small-cell Lung... Renal Cell Carc... Pancreas Cancer Melanoma NSCLC Urothelial Carc... Cervical Cancer Microsatellite ... Merkel Cell Car...	Allogeneic natu...	18 Years -	Fate Therapeutics
FATE-NK100 as Monotherapy and in Combination With Monoclonal Antibody in Subjects With Advanced Solid Tumors	NCT03319459	HER2 Positive G... Colorectal Canc... Head and Neck S... EGFR Positive S... Advanced Solid ... HER2-positive B... Hepatocellular ... Non Small Cell ... Renal Cell Carc... Pancreatic Canc... Melanoma	FATE-NK100 Cetuximab Trastuzumab	18 Years -	Fate Therapeutics
Long-term, Non-interventional, Observational Study Following Treatment With Fate Therapeutics FT500 Cellular Immunotherapy	NCT04106167	Advanced Solid ... Lymphoma Gastric Cancer Colorectal Canc... Head and Neck C... Squamous Cell C... EGFR Positive S... HER2-positive B... Hepatocellular ... Small-cell Lung... Renal Cell Carc... Pancreas Cancer Melanoma NSCLC Urothelial Carc... Cervical Cancer Microsatellite ... Merkel Cell Car...	Allogeneic natu...	18 Years -	Fate Therapeutics
FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors	NCT03841110	Advanced Solid ... Lymphoma Gastric Cancer Colorectal Canc... Head and Neck C... Squamous Cell C... EGFR Positive S... HER2-positive B... Hepatocellular ... Small Cell Lung... Renal Cell Carc... Pancreas Cancer Melanoma NSCLC Urothelial Carc... Cervical Cancer Microsatellite ... Merkel Cell Car...	FT500 Nivolumab Pembrolizumab Atezolizumab Cyclophosphamid... Fludarabine IL-2	18 Years -	Fate Therapeutics
Long-term, Non-interventional, Observational Study Following Treatment With Fate Therapeutics FT500 Cellular Immunotherapy	NCT04106167	Advanced Solid ... Lymphoma Gastric Cancer Colorectal Canc... Head and Neck C... Squamous Cell C... EGFR Positive S... HER2-positive B... Hepatocellular ... Small-cell Lung... Renal Cell Carc... Pancreas Cancer Melanoma NSCLC Urothelial Carc... Cervical Cancer Microsatellite ... Merkel Cell Car...	Allogeneic natu...	18 Years -	Fate Therapeutics

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