Trials / Terminated
TerminatedNCT04106167
Long-term, Non-interventional, Observational Study Following Treatment With Fate Therapeutics FT500 Cellular Immunotherapy
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 20 (actual)
- Sponsor
- Fate Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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 Subjects will automatically enroll into study FT-003 once they have withdrawn or complete the parent interventional study.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.
Detailed description
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.
Conditions
- Advanced Solid Tumor
- Lymphoma
- Gastric Cancer
- Colorectal Cancer
- Head and Neck Cancer
- Squamous Cell Carcinoma
- EGFR Positive Solid Tumor
- HER2-positive Breast Cancer
- Hepatocellular Carcinoma
- Small-cell Lung Cancer
- Renal Cell Carcinoma
- Pancreas Cancer
- Melanoma
- NSCLC
- Urothelial Carcinoma
- Cervical Cancer
- Microsatellite Instability
- Merkel Cell Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | Allogeneic natural killer (NK) cell | 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 |
Timeline
- Start date
- 2019-06-11
- Primary completion
- 2023-08-11
- Completion
- 2023-08-11
- First posted
- 2019-09-26
- Last updated
- 2023-09-21
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04106167. Inclusion in this directory is not an endorsement.