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

NCT ID: NCT03912831

Last Updated: 2023-12-26

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-30

Study Completion Date

2022-02-18

Brief Summary

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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.

Detailed Description

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Conditions

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Human Papillomavirus (HPV) 16+ Relapsed/Refractory Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase 1A: 1 x 10^6 KITE-439 (Cohort 1)

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.

Group Type EXPERIMENTAL

KITE-439

Intervention Type DRUG

A single infusion of E7 TCR T cells (KITE-439).

Cyclophosphamide

Intervention Type DRUG

Administered intravenously.

Fludarabine

Intervention Type DRUG

Administered intravenously.

Interleukin-2

Intervention Type DRUG

Administered subcutaneously.

Phase 1A: 3 x 10^6 KITE-439 (Cohort 2)

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.

Group Type EXPERIMENTAL

KITE-439

Intervention Type DRUG

A single infusion of E7 TCR T cells (KITE-439).

Cyclophosphamide

Intervention Type DRUG

Administered intravenously.

Fludarabine

Intervention Type DRUG

Administered intravenously.

Interleukin-2

Intervention Type DRUG

Administered subcutaneously.

Phase 1A: 1 x 10^7 KITE-439 (Cohort 3)

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.

Group Type EXPERIMENTAL

KITE-439

Intervention Type DRUG

A single infusion of E7 TCR T cells (KITE-439).

Cyclophosphamide

Intervention Type DRUG

Administered intravenously.

Fludarabine

Intervention Type DRUG

Administered intravenously.

Interleukin-2

Intervention Type DRUG

Administered subcutaneously.

Phase 1A: 3 x 10^7 KITE-439 (Cohort 4)

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.

Group Type EXPERIMENTAL

KITE-439

Intervention Type DRUG

A single infusion of E7 TCR T cells (KITE-439).

Cyclophosphamide

Intervention Type DRUG

Administered intravenously.

Fludarabine

Intervention Type DRUG

Administered intravenously.

Interleukin-2

Intervention Type DRUG

Administered subcutaneously.

Phase 1A: 1 x 10^8 KITE-439 (Cohort 5)

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.

Group Type EXPERIMENTAL

KITE-439

Intervention Type DRUG

A single infusion of E7 TCR T cells (KITE-439).

Cyclophosphamide

Intervention Type DRUG

Administered intravenously.

Fludarabine

Intervention Type DRUG

Administered intravenously.

Interleukin-2

Intervention Type DRUG

Administered subcutaneously.

Phase 1A: 1 x 10^8 KITE-439 (Cohort 6)

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.

Group Type EXPERIMENTAL

KITE-439

Intervention Type DRUG

A single infusion of E7 TCR T cells (KITE-439).

Cyclophosphamide

Intervention Type DRUG

Administered intravenously.

Fludarabine

Intervention Type DRUG

Administered intravenously.

Interleukin-2

Intervention Type DRUG

Administered subcutaneously.

Phase 1B: KITE-439

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.

Group Type EXPERIMENTAL

KITE-439

Intervention Type DRUG

A single infusion of E7 TCR T cells (KITE-439).

Cyclophosphamide

Intervention Type DRUG

Administered intravenously.

Fludarabine

Intervention Type DRUG

Administered intravenously.

Interleukin-2

Intervention Type DRUG

Administered subcutaneously.

Interventions

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KITE-439

A single infusion of E7 TCR T cells (KITE-439).

Intervention Type DRUG

Cyclophosphamide

Administered intravenously.

Intervention Type DRUG

Fludarabine

Administered intravenously.

Intervention Type DRUG

Interleukin-2

Administered subcutaneously.

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kite Study Director

Role: STUDY_DIRECTOR

Kite, A Gilead Company

Locations

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Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Site Status

City of Hope

Duarte, California, United States

Site Status

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

Site Status

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Site Status

University of Chicago Medical Center

Chicago, Illinois, United States

Site Status

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Kirtane K; Massarelli E; Hanna GJ; et al KITE-439: A Phase 1 Study of HPV16 E7 T Cell Receptor-engineered T Cells in Patients with Relapsed/Refractory HPV16-positive Cancers. ASCO Poster 2020

Reference Type RESULT

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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KT-US-478-0401

Identifier Type: -

Identifier Source: org_study_id