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Development program terminated
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Phase 1A: 3 x 10^7 KITE-439 (Cohort 4) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KITE-439 | Drug | A single infusion of E7 TCR T cells (KITE-439). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Up to 1.4 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 1.4 years |
| Phase 1B: Progression-Free Survival (PFS) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Kite Study Director | Kite, A Gilead Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | United States | ||
| City of Hope |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42266673 | Result | 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. |
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8 participants were screened. The study was terminated earlier than planned, and thus the study did not proceed to Phase 1B.
Participants were enrolled at study sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1A: 1 x 10^6 KITE-439 (Cohort 1) | Participants received 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 21, 2021 |
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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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Cyclophosphamide | Drug | Administered intravenously. |
|
| Fludarabine | Drug | Administered intravenously. |
|
| Interleukin-2 | Drug | Administered subcutaneously. |
|
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. |
| 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. | Up to 1.4 years |
| Phase 1B: Percentage of Participants Experiencing Adverse Events | Up to 1.4 years |
| Phase 1B: Percentage of Participants With Anti-KITE-439 Antibodies | Up to 1.4 years |
| Phase 1B: Percentage of Participants With Replication-competent Retrovirus (RCR) | Up to 1.4 years |
| Phase 1B: Levels of E7 TCR T Cells | Up to 1.4 years |
| Duarte |
| California |
| 91010 |
| United States |
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90095 | United States |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60640 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
| FG001 | Phase 1A: 3 x 10^6 KITE-439 (Cohort 2) | Participants received 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. |
| FG002 | Phase 1A: 1 x 10^7 KITE-439 (Cohort 3) | Participants received 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. |
| FG003 | Phase 1A: 3 x 10^7 KITE-439 (Cohort 4) | Participants received 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. |
| FG004 | Phase 1A: 1 x 10^8 KITE-439 (Cohort 5) | Participants received 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 was 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. |
| FG005 | Phase 1A: 1 x 10^8 KITE-439 (Cohort 6) | Participants received 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 was 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety analysis set included all participants who were treated with any dose of KITE-439.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1A: 1 x 10^6 KITE-439 (Cohort 1) | Participants received 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 × 10^6 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. |
| BG001 | Phase 1A: 3 x 10^6 KITE-439 (Cohort 2) | Participants received 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. |
| BG002 | Phase 1A: 1 x 10^7 KITE-439 (Cohort 3) | Participants received 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. |
| BG003 | Phase 1A: 3 x 10^7 KITE-439 (Cohort 4) | Participants received 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. |
| BG004 | Phase 1A: 1 x 10^8 KITE-439 (Cohort 5) | Participants received 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 was 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. |
| BG005 | Phase 1A: 1 x 10^8 KITE-439 (Cohort 6) | Participants received 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 was 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. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Number | percentage of participants | First infusion date of KITE-439 up to 21 days |
|
|
| |||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | Due to early termination of study, Phase 1B dose of KITE-439 was not established and Phase 1B of study was not conducted. | Posted | Up to 1.4 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Due to early termination of study, Phase 1B dose of KITE-439 was not established and Phase 1B of study was not conducted. | Posted | Up to 1.4 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Due to early termination of study, Phase 1B dose of KITE-439 was not established and Phase 1B of study was not conducted. | Posted | Up to 1.4 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Phase 1B: Overall Survival | Overall survival was defined as the time from KITE-439 infusion to the date of death. | Due to early termination of study, Phase 1B dose of KITE-439 was not established and Phase 1B of study was not conducted. | Posted | Up to 1.4 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Phase 1B: Percentage of Participants Experiencing Adverse Events | Due to early termination of study, Phase 1B dose of KITE-439 was not established and Phase 1B of study was not conducted. | Posted | Up to 1.4 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Phase 1B: Percentage of Participants With Anti-KITE-439 Antibodies | Due to early termination of study, Phase 1B dose of KITE-439 was not established and Phase 1B of study was not conducted. | Posted | Up to 1.4 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Phase 1B: Percentage of Participants With Replication-competent Retrovirus (RCR) | Due to early termination of study, Phase 1B dose of KITE-439 was not established and Phase 1B of study was not conducted. | Posted | Up to 1.4 years |
|
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Phase 1B: Levels of E7 TCR T Cells | Due to early termination of study, Phase 1B dose of KITE-439 was not established and Phase 1B of study was not conducted. | Posted | Up to 1.4 years |
|
|
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).
Safety analysis set included all participants who were treated with any dose of KITE-439.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1A: 1 x 10^6 KITE-439 (Cohort 1) | Participants received 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 × 10^6 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. | 1 | 1 | 1 | 1 | 1 | 1 |
| EG001 | Phase 1A: 3 x 10^6 KITE-439 (Cohort 2) | Participants received 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. | 1 | 1 | 0 | 1 | 1 | 1 |
| EG002 | Phase 1A: 1 x 10^7 KITE-439 (Cohort 3) | Participants received 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. | 1 | 1 | 1 | 1 | 1 | 1 |
| EG003 | Phase 1A: 3 x 10^7 KITE-439 (Cohort 4) | Participants received 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. | 1 | 1 | 1 | 1 | 1 | 1 |
| EG004 | Phase 1A: 1 x 10^8 KITE-439 (Cohort 5) | Participants received 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 was 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. | 3 | 3 | 2 | 3 | 3 | 3 |
| EG005 | Phase 1A: 1 x 10^8 KITE-439 (Cohort 6) | Participants received 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 was 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. | 1 | 1 | 0 | 1 | 1 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial flutter | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.1) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (24.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Anal incontinence | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Mucosal dryness | General disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (24.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (24.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (24.1) | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information | Kite, A Gilead Company | 844-454-5483 (1-844-454-KITE) | medinfo@kitepharma.com |
| Dec 19, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| D007376 | Interleukin-2 |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|