In short
KITE-363 is an investigational gene-modified cell therapy being studied in people with solid and hematological malignancies. It is currently being evaluated in one authorised long-term follow-up study (NCT05041309) that includes 504 participants. The trial is in Phase 2 and focuses on monitoring late-onset side effects after treatment with gene-modified cells.
Key points
- KITE-363 is an investigational gene-modified cell therapy given by intravenous use.
- It is being studied in a Phase 2 long-term follow-up trial for solid and hematological malignancies.
- The trial has 504 participants enrolled.
- The study monitors late-onset side effects including neurological, autoimmune, and hematological disorders.
- The trial is currently authorised and listed on ClinicalTrials.gov as NCT05041309.
What is KITE-363?
KITE-363 is an investigational gene-modified cell therapy. It is a cell-based product that is administered by intravenous use. The substance appears in a long-term follow-up study alongside two other gene-modified cell therapies, Tecartus and YESCARTA. KITE-363 is not yet authorised as a medicine and is being investigated in clinical research.
How does KITE-363 work?
The available registry data do not describe the specific mechanism of action of KITE-363. It is classified as a gene-modified cell therapy, meaning it is made from cells that have been genetically altered. The trial record indicates that KITE-363 is related to chimeric antigen receptor (CAR) T cell approaches, as the study monitors for the presence of the chimeric antigen receptor transgene. However, the exact molecular target of KITE-363 is not stated in the available sources.
Which conditions is KITE-363 studied for?
- Solid malignancies — cancers that form solid tumours in organs or tissues.
- Hematological malignancies — cancers that affect the blood, bone marrow, or lymph nodes.
These are the conditions listed in the long-term follow-up study in which KITE-363 appears.
How is KITE-363 given?
KITE-363 is given by intravenous use, meaning it is administered directly into a vein. The trial record does not report a specific dose for KITE-363.
What do the clinical trials show?
There is one clinical trial involving KITE-363. It is a Phase 2 long-term follow-up study with 504 participants. The trial is currently authorised.
The study measures the occurrence of late-onset side effects suspected to be related to gene-modified cells, including neurological disorders, autoimmune disorders, hematological disorders, serious infections, and new malignancies. It also evaluates growth, development, and sexual maturity in children and adolescents treated with gene-modified cells.
Participants are people who have already received gene-modified cell treatment in earlier Kite studies.
What side effects are known?
The trial is specifically designed to monitor late-onset side effects, including neurological disorders, autoimmune disorders, hematological disorders, serious infections, and new malignancies. No additional side effect information for KITE-363 is provided in the available sources.