Human Papillomavirus (HPV) 16+ Relapsed/Refractory CancerPhase 1NCT03912831

Study to Evaluate the Safety and Efficacy of KITE-439 in HLA-A*02:01+ Adults With Relapsed/Refractory HPV16+ Cancers

A Phase 1 study testing KITE-439, Cyclophosphamide and Fludarabine in people with Human Papillomavirus (HPV) 16+ Relapsed/Refractory Cancer, run by Gilead Sciences at 9 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Human Papillomavirus (HPV) 16+ Relapsed/Refractory Cancer
What is being tested?: KITE-439, Cyclophosphamide and Fludarabine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 9 sitesUnited States
Study dates: 30 Apr 2019to 18 Feb 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Advanced cancer defined as relapsed or refractory disease after at least 1 line of therapy that included systemic chemotherapy and that is not amenable to definitive locoregional therapy
HPV16+ tumor as confirmed by the central laboratory
HLA type is HLA-A*02:01+ per local assessment
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Who cannot join

Presence of fungal, bacterial, viral, or other infection requiring anti-microbials for management
Note: Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the Kite medical monitor
Primary immunodeficiency
History of autoimmune disease (eg, Crohns, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years prior to enrollment
Known history of infection with human immunodeficiency virus (HIV), hepatitis B (HBsAg positive), or hepatitis C (anti-HCV positive). A history of treated hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative polymerase chain reaction (qPCR) and/or nucleic acid testing
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
University of Chicago Medical Center
Chicago, Illinois, 60640
City of Hope
Duarte, California, 91010
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Phase 1 Study Evaluating the Safety and Efficacy of HPV16 E7 T Cell Receptor Engineered T Cells (KITE-439) in HLA-A*02:01+ Subjects With Relapsed/Refractory HPV16+ Cancers

Conditions: Human Papillomavirus (HPV) 16+ Relapsed/Refractory Cancer
Being tested: KITE-439, Cyclophosphamide, Fludarabine, Interleukin-2
Medical subject headings: Papillomavirus Infections, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KITE-439Drug
A single infusion of E7 TCR T cells (KITE-439).
CyclophosphamideDrug
Administered intravenously.
FludarabineDrug
Administered intravenously.
Interleukin-2Drug
Administered subcutaneously.

Study groups in NCT03912831
Study group	Role	What they receive
Phase 1A: 1 x 10^6 KITE-439 (Cohort 1)	Experimental	Participants will receive conditioning chemotherapy of cyclophosphamide 30 mg/kg, intravenous (IV) infusion, once on Days -7 and -6 and fludarabine, 25 mg/m^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 1 × 10^6 E7 T-cell receptor (TCR) T cells/kg on Day 0 along with the interleukin-2 of 2,50,000 IU/kg, subcutaneous (SC) injection, once on Days 0 to 6. Receives: Drug: KITE-439; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Interleukin-2
Phase 1A: 3 x 10^6 KITE-439 (Cohort 2)	Experimental	Participants will receive conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 3 × 10^6 E7 TCR T cells/kg on Day 0 along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6. Receives: Drug: KITE-439; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Interleukin-2
Phase 1A: 1 x 10^7 KITE-439 (Cohort 3)	Experimental	Participants will receive conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 1 × 10^7 E7 TCR T cells/kg on Day 0 along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6. Receives: Drug: KITE-439; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Interleukin-2
Phase 1A: 3 x 10^7 KITE-439 (Cohort 4)	Experimental	Participants will receive conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 3 × 10^7 E7 TCR T cells/kg on Day 0 along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6. Receives: Drug: KITE-439; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Interleukin-2
Phase 1A: 1 x 10^8 KITE-439 (Cohort 5)	Experimental	Participants will receive conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 1 × 10^8 E7 TCR T cells/kg on Day 0 (maximum allowable dose is 5 × 10^9 E7 TCR T cells) along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6. Receives: Drug: KITE-439; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Interleukin-2
Phase 1A: 1 x 10^8 KITE-439 (Cohort 6)	Experimental	Participants will receive conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 1 × 10^8 E7 TCR T cells/kg on Day 0 (maximum allowable dose is 1 × 10^10 E7 TCR T cells) along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6. Receives: Drug: KITE-439; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Interleukin-2
Phase 1B: KITE-439	Experimental	Participants will receive cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, at a dose selected based on Phase 1A along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6. Receives: Drug: KITE-439; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Interleukin-2

What is being measured

The primary outcome is the main question the study is designed to answer.

Phase 1A: Percentage of Participants Experiencing Adverse Events Defined as Dose-Limiting Toxicities (DLTs)
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.
Measured: First infusion date of KITE-439 up to 21 days
Phase 1B: Objective Response Rate (ORR)
ORR was defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) as evaluated by modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measured: Up to 1.4 years

Secondary outcomes (7)

Phase 1B: Duration of Response (DOR)
For participants who experience an objective response, DOR was defined as the time from the date of their first objective response to the date of disease progression per modified RECIST v1.1 or death from any cause.
Measured: Up to 1.4 years
Phase 1B: Progression-Free Survival (PFS)
PFS was defined as the time from the KITE-439 infusion date to the date of disease progression per modified RECIST v1.1 or death from any cause.
Measured: Up to 1.4 years
Phase 1B: Overall Survival
Overall survival was defined as the time from KITE-439 infusion to the date of death.
Measured: Up to 1.4 years
Phase 1B: Percentage of Participants Experiencing Adverse Events
Measured: Up to 1.4 years
Phase 1B: Percentage of Participants With Anti-KITE-439 Antibodies
Measured: Up to 1.4 years
Phase 1B: Percentage of Participants With Replication-competent Retrovirus (RCR)
Measured: Up to 1.4 years
Phase 1B: Levels of E7 TCR T Cells
Measured: Up to 1.4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Apr 201918 Feb 2022

First posted11 Apr 2019
Study start30 Apr 2019
Primary completion18 Feb 2022
Study completion18 Feb 2022

Why it stopped: Development program terminated

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Human Papillomavirus (HPV) 16+ Relapsed/Refractory CancerStudies of the same condition, open and under way.
More trials run by Gilead SciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03912831
Sponsor's protocol ID: KT-US-478-0401
Status last verified: Dec 2023
First submitted: 10 Apr 2019
Last updated: 26 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Kirtane K, Niu J, Blumenschein G, Massarelli E, Hanna GJ, Lee S, Bishop MR, Konecny GE, Mao D, Zheng Y, Rodriguez K, Kim JJ, Williams C, Schweitzer C, Adhikary S, Jung AS, Klebanoff CA. A phase 1 trial of HPV16 E7 T-cell receptor-engineered T cells in patients with relapsed/refractory HPV16-positive cancers (KITE-439 trial). Front Oncol. 2026 May 21;16:1809354. doi: 10.3389/fonc.2026.1809354. eCollection 2026.
PubMed 42266673

Study at a glance

From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Study Evaluating the Safety and Efficacy of HPV16 E7 T Cell Receptor Engineered T Cells (KITE-439) in HLA-A*02:01+ Subjects With Relapsed/Refractory HPV16+ Cancers
ClinicalTrials.gov ID: NCT03912831
Acronym / sponsor ID: KT-US-478-0401
Conditions: Human Papillomavirus (HPV) 16+ Relapsed/Refractory Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Development program terminated
Enrolment: 8 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: 30 Apr 2019 (actual)
Primary completion: 18 Feb 2022 (actual)
Study completion: 18 Feb 2022 (actual)
First posted: 11 Apr 2019 (actual)
Results: Posted 26 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 7

Arm	Type	Receives
Phase 1A: 1 x 10^6 KITE-439 (Cohort 1)	Experimental	Drug: KITE-439, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: Interleukin-2Participants will receive conditioning chemotherapy of cyclophosphamide 30 mg/kg, intravenous (IV) infusion, once on Days -7 and -6 and fludarabine, 25 mg/m^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 1 × 10^6 E7 T-cell receptor (TCR) T cells/kg on Day 0 along with the interleukin-2 of 2,50,000 IU/kg, subcutaneous (SC) injection, once on Days 0 to 6.
Phase 1A: 3 x 10^6 KITE-439 (Cohort 2)	Experimental	Drug: KITE-439, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: Interleukin-2Participants will receive conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 3 × 10^6 E7 TCR T cells/kg on Day 0 along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
Phase 1A: 1 x 10^7 KITE-439 (Cohort 3)	Experimental	Drug: KITE-439, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: Interleukin-2Participants will receive conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 1 × 10^7 E7 TCR T cells/kg on Day 0 along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
Phase 1A: 3 x 10^7 KITE-439 (Cohort 4)	Experimental	Drug: KITE-439, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: Interleukin-2Participants will receive conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 3 × 10^7 E7 TCR T cells/kg on Day 0 along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
Phase 1A: 1 x 10^8 KITE-439 (Cohort 5)	Experimental	Drug: KITE-439, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: Interleukin-2Participants will receive conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 1 × 10^8 E7 TCR T cells/kg on Day 0 (maximum allowable dose is 5 × 10^9 E7 TCR T cells) along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
Phase 1A: 1 x 10^8 KITE-439 (Cohort 6)	Experimental	Drug: KITE-439, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: Interleukin-2Participants will receive conditioning chemotherapy of cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, up to 1 × 10^8 E7 TCR T cells/kg on Day 0 (maximum allowable dose is 1 × 10^10 E7 TCR T cells) along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.
Phase 1B: KITE-439	Experimental	Drug: KITE-439, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: Interleukin-2Participants will receive cyclophosphamide 30 mg/kg, IV infusion, once on Days -7 and -6 and fludarabine, 25 mg/m^2, IV infusion, once on Days -7 to -3 followed by KITE-439 infusion, at a dose selected based on Phase 1A along with the interleukin-2 of 2,50,000 IU/kg, SC injection, once on Days 0 to 6.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Advanced cancer defined as relapsed or refractory disease after at least 1 line of therapy that included systemic chemotherapy and that is not amenable to definitive locoregional therapy
HPV16+ tumor as confirmed by the central laboratory
HLA type is HLA-A*02:01+ per local assessment
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Key exclusion criteria (6 listed)

Presence of fungal, bacterial, viral, or other infection requiring anti-microbials for management
Primary immunodeficiency
History of autoimmune disease (eg, Crohns, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years prior to enrollment
Known history of infection with human immunodeficiency virus (HIV), hepatitis B (HBsAg positive), or hepatitis C (anti-HCV positive). A history of treated hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative polymerase chain reaction (qPCR) and/or nucleic acid testing
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
KITE-439A single infusion of E7 TCR T cells (KITE-439).	Drug	Phase 1A: 1 x 10^6 KITE-439 (Cohort 1), Phase 1A: 1 x 10^7 KITE-439 (Cohort 3), Phase 1A: 1 x 10^8 KITE-439 (Cohort 5), Phase 1A: 1 x 10^8 KITE-439 (Cohort 6), Phase 1A: 3 x 10^6 KITE-439 (Cohort 2), Phase 1A: 3 x 10^7 KITE-439 (Cohort 4), Phase 1B: KITE-439
CyclophosphamideAdministered intravenously.	Drug	Phase 1A: 1 x 10^6 KITE-439 (Cohort 1), Phase 1A: 1 x 10^7 KITE-439 (Cohort 3), Phase 1A: 1 x 10^8 KITE-439 (Cohort 5), Phase 1A: 1 x 10^8 KITE-439 (Cohort 6), Phase 1A: 3 x 10^6 KITE-439 (Cohort 2), Phase 1A: 3 x 10^7 KITE-439 (Cohort 4), Phase 1B: KITE-439
FludarabineAdministered intravenously.	Drug	Phase 1A: 1 x 10^6 KITE-439 (Cohort 1), Phase 1A: 1 x 10^7 KITE-439 (Cohort 3), Phase 1A: 1 x 10^8 KITE-439 (Cohort 5), Phase 1A: 1 x 10^8 KITE-439 (Cohort 6), Phase 1A: 3 x 10^6 KITE-439 (Cohort 2), Phase 1A: 3 x 10^7 KITE-439 (Cohort 4), Phase 1B: KITE-439
Interleukin-2Administered subcutaneously.	Drug	Phase 1A: 1 x 10^6 KITE-439 (Cohort 1), Phase 1A: 1 x 10^7 KITE-439 (Cohort 3), Phase 1A: 1 x 10^8 KITE-439 (Cohort 5), Phase 1A: 1 x 10^8 KITE-439 (Cohort 6), Phase 1A: 3 x 10^6 KITE-439 (Cohort 2), Phase 1A: 3 x 10^7 KITE-439 (Cohort 4), Phase 1B: KITE-439

Primary outcome

Phase 1A: Percentage of Participants Experiencing Adverse Events Defined as Dose-Limiting Toxicities (DLTs)
Time frame: 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.
Phase 1B: Objective Response Rate (ORR)
Time frame: Up to 1.4 years
ORR was defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) as evaluated by modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

7 secondary outcomes

Phase 1B: Duration of Response (DOR)
Time frame: Up to 1.4 years
Phase 1B: Progression-Free Survival (PFS)
Time frame: Up to 1.4 years
Phase 1B: Overall Survival
Time frame: Up to 1.4 years
Phase 1B: Percentage of Participants Experiencing Adverse Events
Time frame: Up to 1.4 years
Phase 1B: Percentage of Participants With Anti-KITE-439 Antibodies
Time frame: Up to 1.4 years
Phase 1B: Percentage of Participants With Replication-competent Retrovirus (RCR)
Time frame: Up to 1.4 years
Phase 1B: Levels of E7 TCR T Cells
Time frame: Up to 1.4 years

Results and safety

Results posted to the registry on 26 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1A: 1 x 10^6 KITE-439 (Cohort 1)	1	0
Phase 1A: 3 x 10^6 KITE-439 (Cohort 2)	1	0
Phase 1A: 1 x 10^7 KITE-439 (Cohort 3)	1	0
Phase 1A: 3 x 10^7 KITE-439 (Cohort 4)	1	0
Phase 1A: 1 x 10^8 KITE-439 (Cohort 5)	3	0
Phase 1A: 1 x 10^8 KITE-439 (Cohort 6)	1	0

Primary outcome: Phase 1A: Percentage of Participants Experiencing Adverse Events Defined as Dose-Limiting Toxicities (DLTs)

Time frame: First infusion date of KITE-439 up to 21 days. Number. Unit: percentage of participants

Measure	Phase 1A: 1 x 10^6 KITE-439 (Cohort 1) n = 1	Phase 1A: 3 x 10^6 KITE-439 (Cohort 2) n = 1	Phase 1A: 1 x 10^7 KITE-439 (Cohort 3) n = 1	Phase 1A: 3 x 10^7 KITE-439 (Cohort 4) n = 1	Phase 1A: 1 x 10^8 KITE-439 (Cohort 5) n = 3	Phase 1A: 1 x 10^8 KITE-439 (Cohort 6) n = 1
Value	0	0	0	0	0	0

Population analysed: DLT evaluable set included participants treated in Phase 1A who received the target dose (± 20%) and had the opportunity to be followed for at least 21 days after the KITE-439 infusion or received a dose of KITE-439 lower than the target dose and experienced a DLT within 21 days after the KITE-439 infusion.

Primary outcome: Phase 1B: Objective Response Rate (ORR)

Time frame: Up to 1.4 years

Population analysed: Due to early termination of study, Phase 1B dose of KITE-439 was not established and Phase 1B of study was not conducted.

7 secondary outcomes are reported in the full results.

Adverse events

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).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1A: 1 x 10^6 KITE-439 (Cohort 1)	1 of 1 (100%)	1 of 1 (100%)	1 of 1
Phase 1A: 3 x 10^6 KITE-439 (Cohort 2)	0 of 1 (0%)	1 of 1 (100%)	1 of 1
Phase 1A: 1 x 10^7 KITE-439 (Cohort 3)	1 of 1 (100%)	1 of 1 (100%)	1 of 1
Phase 1A: 3 x 10^7 KITE-439 (Cohort 4)	1 of 1 (100%)	1 of 1 (100%)	1 of 1
Phase 1A: 1 x 10^8 KITE-439 (Cohort 5)	2 of 3 (66.7%)	3 of 3 (100%)	3 of 3
Phase 1A: 1 x 10^8 KITE-439 (Cohort 6)	0 of 1 (0%)	1 of 1 (100%)	1 of 1

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 42266673Kirtane K, Niu J, Blumenschein G, Massarelli E, Hanna GJ, Lee S, Bishop MR, Konecny GE, Mao D, Zheng Y, Rodriguez K, Kim JJ, Williams C, Schweitzer C, Adhikary S, Jung AS, Klebanoff CA. A phase 1 trial of HPV16 E7 T-cell receptor-engineered T cells in patients with relapsed/refractory HPV16-positive cancers (KITE-439 trial). Front Oncol. 2026 May 21;16:1809354. doi: 10.3389/fonc.2026.1809354. eCollection 2026.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kite Study Director study director

Kite, A Gilead Company

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KITE-439, Cyclophosphamide and Fludarabine in people with Human Papillomavirus (HPV) 16+ Relapsed/Refractory Cancer, run by Gilead Sciences at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1A: Percentage of Participants Experiencing Adverse Events Defined as Dose-Limiting Toxicities (DLTs) (time frame: First infusion date of KITE-439 up to 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03912831, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.