Long-term Follow-Up Study Following Treatment With Fate Therapeutics' Engineered Cellular Immunotherapy

NCT04093622 | Terminated FDA Drug

• 1 other identifier: FT-004
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of the study is to assess long-term side effects from subjects who receive a Fate Therapeutics genetically modified NK cell product. Subjects who previously took part in a Fate Therapeutics study and received genetically changed NK cells will take part in this long-term follow-up study. Subjects will join this study once they complete the parent interventional 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. For a period of 15 years starting from the last administration of Fate Therapeutics genetically modified NK cell product, subjects will be assessed for long-term safety and survival through questionnaires and blood tests.

Conditions

Hematological Malignancy

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS) post-infusion

  OS defined as the interval between the date of first Fate Therapeutics genetically modified NK cell product infusion and date of death due to any cause.

  15 years post last treatment

Secondary Outcomes (1)

• Incidence of LTFU adverse events (AEs), including serious adverse events (SAEs) associated with administration of Fate Therapeutics genetically modified NK cell product that have been genetically modified by lentiviral vectors.

  15 years post last treatment

Study Arms (1)

Genetically engineered NK Cell - treated

Long term follow-up of subjects who have received lentivirus-mediated genetically engineered NK Cells.

Genetic: Genetically engineered NK cells

Interventions

Genetically engineered NK cells GENETIC

No study drug is administered in this study. Subjects who received lentivirus-mediated genetically engineered NK Cells in a previous trial will be evaluated in this trial for long-term safety and efficacy.

Genetically engineered NK Cell - treated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects hematological malignancies rolling over from interventional study where they were treated with Fate Therapeutics genetically modified NK cell product.

You may qualify if:

• Received engineered cellular immunotherapy in a Fate Therapeutics Interventional Study

You may not qualify if:

• Not Applicable

Sponsors & Collaborators

• Fate Therapeutics: lead

Study Sites (5)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

UC San Diego

San Diego, California, 92037, United States

Location

University of Minnesota Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Multiple samples including: whole blood and serum

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Rebecca Elstrom, MD

  Fate Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 18, 2019
• Study Start: October 4, 2019
• Primary Completion: April 9, 2020
• Study Completion: April 9, 2020
• Last Updated: August 29, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)