Other Clinical Trial - Long-term Follow-up Study for Participants of

Clinical Trial Summary

The goal of this clinical study is to learn more about the long-term safety, effectiveness and prolonged action of Kite study drugs, axicabtagene ciloleucel, brexucabtagene autoleucel, KITE-222, KITE-363, KITE-439, KITE-585, and KITE-718, in participants of Kite-sponsored interventional studies.

See also
Status	Clinical Trial	Phase
Completed	`NCT04944771` - Study to Assess the Effect of Food and Acid Reducing Agents on the Absorption of Capivasertib in Healthy Participants	Phase 1
Terminated	`NCT03391791` - Long Term Follow up of Subjects Exposed to Genetically Engineered T Cell Receptors
Recruiting	`NCT02636855` - Screening Protocol for Tumor Antigen Expression Profiling and HLA Typing for Eligibility Determination

See also

Status

Clinical Trial

Phase

Completed

NCT04944771 - Study to Assess the Effect of Food and Acid Reducing Agents on the Absorption of Capivasertib in Healthy Participants

Phase 1

Terminated

NCT03391791 - Long Term Follow up of Subjects Exposed to Genetically Engineered T Cell Receptors

Recruiting

NCT02636855 - Screening Protocol for Tumor Antigen Expression Profiling and HLA Typing for Eligibility Determination

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT05041309
Study type	Interventional
Source	Gilead Sciences
Contact
Status	Enrolling by invitation
Phase	Phase 2
Start date	December 15, 2021
Completion date	December 2040

Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms