Long-Term Follow-Up Study After Gene-Modified Cell Treatment in Kite Studies

StatusEnrolling by Invitation

PhaseNot specified

SponsorKite, A Gilead Company

Started2021-12-15

View on ClinicalTrials.gov ↗

Trial flagged as At Risk

Primary endpoints added 5 → 7 primary endpoints

See other at-risk trials from Gilead Sciences

Amendment history

The 50 most recent of 53 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

2026-09-22

Primary endpoint(s) modified5 to 7 entries

WasHeight of Pediatric and Adolescent Participants, Percentage of Participants Experiencing Late-onset Targeted Adverse Events (AEs), Percentage of Participants Experiencing Late-onset Targeted Serious Adverse Events (SAEs), Sexual Maturation of Pediatric and Adolescent Participants Assessed by Tanner Pubertal Stage Scale Score, Weight of Pediatric and Adolescent Participants

NowHeight of Pediatric and Adolescent Participants, Percentage of Participants Experiencing Late-onset Targeted Adverse Events (AEs), Percentage of Participants Experiencing Late-onset Targeted Serious Adverse Events (SAEs), Percentage of Participants Experiencing Related SAEs, Percentage of Participants With New Malignancies, Sexual Maturation of Pediatric and Adolescent Participants Assessed by Tanner Pubertal Stage Scale Score, Weight of Pediatric and Adolescent Participants

Enrollment increased: 1000 → 1500 participants

Trial arms changed: 6 → 11

Interventions modified

2026-05-13

Study Status, Contacts/Locations v52

Study sites89→90

2026-02-24

Study Status, Contacts/Locations v51

Study sites87→89

2025-10-08

Study Identification, Study Status, Contacts/Locations v50

Study sites86→87

2025-09-19

Study Status, Contacts/Locations v49

Study sites83→86

Show 46 earlier versions

2025-06-17

Study Status, Contacts/Locations v48

Study sites81→83

2025-02-05

Study Status, Contacts/Locations v47

Study sites80→81

2025-01-13

Study Status, Contacts/Locations v46

Study sites77→80

2024-12-19

Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v45

PhasePhase 2→Not specified

Enrollment target700→1000

Study sites69→77

Study arms7→6

InterventionsAxicabtagene Ciloleucel (Biological), Brexucabtagene Autoleucel (Biological), KITE-222 (Biological), KITE-363 (Biological), KITE-439…→Anitocabtagene autleucel (Biological), Axicabtagene Ciloleucel (Biological), Brexucabtagene Autoleucel (Biological), KITE-197 (Biological)…

Secondary endpoints5 to 6 entries

Percentage of Participants With Cause of Death ~~Peripheral~~Overall ~~B-cell and Lymphocytes Levels for Immune Reconstitution~~ Rate of Replication-competent Retrovirus/Replication-competent Lentivirus (RCR/RCL) Percentage of Participants With Vector Integration Site(s) for Replication-competent Retrovirus/Replication-competent Lentivirus (RCR/RCL) or Insertional Mutagenesis for Confirmed Events Related to the Cell Therapy Product Percentage of Participants With Status of Primary Malignant Disease

Primary endpoints6 to 5 entries

Sexual Maturation of Pediatric and Adolescent Participants Assessed by Tanner Pubertal Stage Scale ~~Vector~~ ~~Integration Site(s) for Replication-competent Retrovirus/Replication-competent Lentivirus (RCR/RCL) or Insertional Mutagenesis for Confirmed Events Related to the Cell Therapy Product~~Score

2024-10-08

Study Status v44

Re-verified, no change to tracked fields

2024-09-11

Study Status, Contacts/Locations v43

Study sites67→69

2024-08-22

Study Status, Contacts/Locations v42

Study sites62→67

2024-07-24

Study Status, Contacts/Locations v41

Study sites59→62

2024-07-01

Study Status, Contacts/Locations v40

Study sites57→59

2024-06-10

Study Status, Contacts/Locations v39

Study sites54→57

2024-05-15

Study Status, Contacts/Locations v38

Study sites53→54

2024-04-10

Study Status, Contacts/Locations v37

Primary completion date2041-03→2040-12

Completion date2041-03→2040-12

Study sites50→53

2024-03-08

Study Status, Contacts/Locations v36

Study sites47→50

2024-02-16

3 amendments v33-v35

3 re-verifications since 2023-12-14, no change to tracked fields

2023-11-03

Study Status, Contacts/Locations v32

Study sites46→47

2023-10-06

Study Status, Contacts/Locations v31

Study sites45→46

2023-09-14

Study Status v30

Re-verified, no change to tracked fields

2023-08-28

Study Status, Contacts/Locations v29

Study sites44→45

2023-08-04

Study Status, Contacts/Locations v28

Study sites42→44

2023-07-13

Study Status, Contacts/Locations v27

Primary completion date2026-11→2041-03

Completion date2026-11→2041-03

Study sites39→42

2023-05-24

Study Status, Contacts/Locations v26

Study sites32→39

2023-04-21

Study Status, Contacts/Locations v25

Study sites28→32

2023-03-30

Study Status, Contacts/Locations v24

Study sites27→28

2023-03-17

Study Status, Study Description v23

Re-verified, no change to tracked fields

2023-02-21

Study Status, Contacts/Locations v22

Study sites23→27

2023-01-30

Study Status, Contacts/Locations v21

Study sites21→23

2023-01-09

Study Status, Contacts/Locations v20

Study sites20→21

2022-12-12

Study Status, Contacts/Locations v19

Study sites16→20

2022-11-23

Study Status, Contacts/Locations v18

Study sites15→16

2022-11-02

Study Status v17

Re-verified, no change to tracked fields

2022-10-17

Study Status, Contacts/Locations v16

Study sites12→15

2022-09-27

Study Identification, Study Status, Contacts/Locations v15

Study sites11→12

2022-09-05

Study Status, Contacts/Locations v14

Study sites9→11

2022-08-17

Study Status, Study Design, Arms and Interventions, Contacts/Locations v13

Study sites8→9

Study arms6→7

InterventionsAxicabtagene Ciloleucel (Biological), Brexucabtagene Autoleucel (KTE-X19) (Biological)→Axicabtagene Ciloleucel (Biological), Brexucabtagene Autoleucel (Biological), KITE-222 (Biological), KITE-363 (Biological), KITE-439…

2022-06-29

Study Status, Contacts/Locations v12

Study sites5→8

2022-06-07

Study Status, Contacts/Locations v11

Study sites4→5

2022-05-10

Study Status, Contacts/Locations v10

Study sites3→4

2022-04-11

2 amendments v8-v9

2 re-verifications since 2022-03-17, no change to tracked fields

2022-03-01

Study Status, Contacts/Locations v7

Study sites2→3

2022-02-10

2 amendments v5-v6

2 re-verifications since 2022-01-24, no change to tracked fields

2021-12-20

Study Status, Contacts/Locations v4

Start dateestimated 2021-11→confirmed 2021-12-15

Study sites1→2

2021-11-23

Study Status, Contacts/Locations v3

Trial statusNot Yet Recruiting→Enrolling by Invitation

Study sites0→1

Gilead Sciences

107 trials monitored

See 8 trials at risk

The goal of this clinical study is to learn more about the long-term safety, effectiveness and prolonged action of Kite study drugs, axicabtagene ciloleucel, brexucabtagene autoleucel, KITE-363, KITE-753, KITE-197, anitocabtagene autoleucel, INT2104, KITE-512, ACLX-001, and ACLX002 in participants of Kite-sponsored interventional studies. The primary objectives of this study are to: * Evaluate the incidence and severity of related SAEs, late-onset targeted AEs/SAEs suspected to be possibly related to gene-modified cell therapy, including neurologic disorders, new autoimmune disorders (which are distinct from the study-treated disease), hematologic disorders, serious infections, as well as any new malignancies (regardless of causality) * Evaluate the growth, development, and sexual maturity of pediatric and adolescent participants treated with gene-modified cell therapy.

Trial Details

NCT Number	NCT05041309
Lead Sponsor	Kite, A Gilead Company
Conditions	Solid and Hematological Malignancies, Autoimmune Diseases
Enrollment	1,500 participants
Start Date	2021-12-15
Primary Completion	2040-12 (estimated)
Study Completion	2040-12 (estimated)
Updated on ClinicalTrials.gov	2026-09-21