18 and older, any sex, with Human Papillomavirus (HPV) 16+ Relapsed/Refractory Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Phase 1A: Percentage of Participants Experiencing Adverse Events Defined as Dose-Limiting Toxicities (DLTs)Primary· First infusion date of KITE-439 up to 21 days
A DLT is defined as protocol-defined KITE-439 related Grade 3 events with onset within the first 21 days following KITE-439 infusion and which do not resolve to ≤Grade 2 events within 48 hours, ≥Grade 4 events with onset within the first 21 days following KITE-439 infusion, regardless of duration.
Group
Value
95% CI
Phase 1A: 1 x 10^6 KITE-439 (Cohort 1)
0
Phase 1A: 3 x 10^6 KITE-439 (Cohort 2)
0
Phase 1A: 1 x 10^7 KITE-439 (Cohort 3)
0
Phase 1A: 3 x 10^7 KITE-439 (Cohort 4)
0
Phase 1A: 1 x 10^8 KITE-439 (Cohort 5)
0
Phase 1A: 1 x 10^8 KITE-439 (Cohort 6)
0
Adverse events — posted to ClinicalTrials.gov
Time frame: All-Cause Mortality: Enrollment up to last follow-up visit date of 18 February 2022 (maximum 1.4 years); Adverse Events: First infusion date of KITE-439 up to data cut-off date of 14 February 2022 (maximum 1.4 years)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Phase 1A: 1 x 10^6 KITE-439 (Cohort 1)
Serious: 1/1 (100%)
Deaths: 1/1
Phase 1A: 3 x 10^6 KITE-439 (Cohort 2)
Serious: 0/1 (0%)
Deaths: 1/1
Phase 1A: 1 x 10^7 KITE-439 (Cohort 3)
Serious: 1/1 (100%)
Deaths: 1/1
Phase 1A: 3 x 10^7 KITE-439 (Cohort 4)
Serious: 1/1 (100%)
Deaths: 1/1
Phase 1A: 1 x 10^8 KITE-439 (Cohort 5)
Serious: 2/3 (67%)
Deaths: 3/3
Phase 1A: 1 x 10^8 KITE-439 (Cohort 6)
Serious: 0/1 (0%)
Deaths: 1/1
Serious adverse events (10 terms)
Reaction
System
Phase 1A: 1 x 10^6 KITE-43…
Phase 1A: 3 x 10^6 KITE-43…
Phase 1A: 1 x 10^7 KITE-43…
Phase 1A: 3 x 10^7 KITE-43…
Phase 1A: 1 x 10^8 KITE-43…
Phase 1A: 1 x 10^8 KITE-43…
Atrial flutter
Cardiac disorders
—
—
—
—
—
—
Non-cardiac chest pain
General disorders
—
—
—
—
—
—
Pneumonia
Infections and infestations
—
—
—
—
—
—
Decreased appetite
Metabolism and nutrition disorders
—
—
—
—
—
—
Muscular weakness
Musculoskeletal and connective tissue disorders
—
—
—
—
—
—
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This study has 2 parts: Phase 1A and Phase 1B. The primary objectives of Phase 1A are to evaluate the safety of KITE-439 and to determine a recommended Phase 1B dose. The primary objective of Phase 1B is to estimate the efficacy of KITE-439 in adults who are human leukocyte antigen (HLA)-A\*02:01+ and have relapsed/refractory human papillomavirus (HPV)16+ cancers.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07115368 — Study of GS-1219 in Participants With HIV-1
· Phase 1
· terminated
NCT06784973 — Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection
· Phase 2
· terminated
NCT06683482 — A Qualitative Study on Advanced Breast Cancer Patients and Their Caregivers in Spain
· completed
NCT06613685 — Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated
· Phase 2, PHASE3
· terminated
NCT06585150 — Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection
· Phase 2
· terminated
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gilead Sciences
Last refreshed: 26 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03912831.