Clinical trial · Interventional
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 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
NCT03912831CI-TRIAL-00072540terminatedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Development program terminated
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Papillomavirus (HPV) 16+ Relapsed/Refractory Cancer | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Interleukin-2 | Drug | Aldesleukin | ALIAS |
| KITE-439 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- Phase 1A: 1 x 10^6 KITE-439 (Cohort 1)
- description
- 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.
- interventionNames
- Drug: KITE-439
- Drug: Cyclophosphamide
- Drug: Fludarabine
- Drug: Interleukin-2
- type
- EXPERIMENTAL
- label
- Phase 1A: 3 x 10^6 KITE-439 (Cohort 2)
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * 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: * 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.
References
Publications (1)
- RESULTKirtane 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. PMID 42266673