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CAR T-cell Therapy

Long-Term Safety of Gene-Modified Cell Therapy for Cancer

Phase 2
Waitlist Available
Research Sponsored by Kite, A Gilead Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years
Awards & highlights

Study Summary

This trial is looking at the safety of a gene-modified cell therapy product, specifically for neurologic, autoimmune, hematologic, and infection-related adverse events, as well as secondary malignancies. They will also be looking at the growth, development, and sexual maturity of pediatric and adolescent subjects treated with the product.

Who is the study for?
This trial is for people who have had blood or other cancers and were treated with gene-modified cells in previous Kite-sponsored studies. They should be able to follow the study plan and agree to all required check-ups. Participants must understand and sign a consent form.Check my eligibility
What is being tested?
The study aims to assess the long-term effects of several gene therapies (Axicabtagene Ciloleucel, Brexucabtagene Autoleucel, KITE-585, etc.) previously administered to participants in earlier trials by Kite Pharma.See study design
What are the potential side effects?
While specific side effects are not listed here, gene therapy can commonly include immune reactions, potential changes in blood counts, fatigue, fever, and could potentially lead to secondary cancers.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Height 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)
+3 more
Secondary outcome measures
Cause of Death
Peripheral B-cell and Lymphocytes Levels for Immune Reconstitution
Rate of Replication-competent Retrovirus/Replication-competent Lentivirus (RCR/RCL)
+2 more

Trial Design

7Treatment groups
Experimental Treatment
Group I: KITE-718Experimental Treatment1 Intervention
All participants who previously received KITE-718 in the parent study will be enrolled in this arm for long-term follow-up.
Group II: KITE-585Experimental Treatment1 Intervention
All participants who previously received KITE-585 in the parent study will be enrolled in this arm for long-term follow-up.
Group III: KITE-439Experimental Treatment1 Intervention
All participants who previously received KITE-439 in the parent study will be enrolled in this arm for long-term follow-up.
Group IV: KITE-363Experimental Treatment1 Intervention
All participants who previously received KITE-363 in the parent study will be enrolled in this arm for long-term follow-up.
Group V: KITE-222Experimental Treatment1 Intervention
All participants who previously received KITE-222 in the parent study will be enrolled in this arm for long-term follow-up.
Group VI: Brexucabtagene Autoleucel (KTE-X19)Experimental Treatment1 Intervention
All participants who previously received brexucabtagene autoleucel (KTE-X19) in the parent study will be enrolled in this arm for long-term follow-up.
Group VII: Axicabtagene Ciloleucel (KTE-C19 )Experimental Treatment1 Intervention
All participants who previously received axicabtagene ciloleucel (KTE-C19 ) in the parent study will be enrolled in this arm for long-term follow-up.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Axicabtagene Ciloleucel
2015
Completed Phase 2
~490

Find a Location

Who is running the clinical trial?

Kite, A Gilead CompanyLead Sponsor
43 Previous Clinical Trials
2,951 Total Patients Enrolled
Kite Study DirectorStudy DirectorKite, A Gilead Company
28 Previous Clinical Trials
2,309 Total Patients Enrolled

Media Library

Axicabtagene Ciloleucel (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05041309 — Phase 2
Cancer Research Study Groups: KITE-363, KITE-439, KITE-222, Axicabtagene Ciloleucel (KTE-C19 ), Brexucabtagene Autoleucel (KTE-X19), KITE-585, KITE-718
Cancer Clinical Trial 2023: Axicabtagene Ciloleucel Highlights & Side Effects. Trial Name: NCT05041309 — Phase 2
Axicabtagene Ciloleucel (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05041309 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what condition is the KITE-363 drug regimen most often applied?

"KITE-363 is frequently employed to abate b-cell lymphomas. Additionally, this medication has been used to address refractory primary mediastinal large b-cell cell lymphoma and treatment resistant cases of b-cell precursor acute lymphoblastic leukemia."

Answered by AI

Is this a pioneering research endeavor?

"Presently, there are 17 trials for KITE-363 running worldwide in 55 cities and 16 countries. This drug was first tested back in 2015 when the study conducted by Gilead's subsidiary Kite, enrolled 307 participants to complete Phase 1 & 2 of the approval process. Since then 0 studies have been completed concerning this medication."

Answered by AI

Is this investigation still recruiting participants?

"This clinical trial has been closed to further recruitment since November 23rd 2022. It was first listed on December 15th 2021, and if you are interested in other studies relating to hematologic neoplasms or KITE-363 there are currently 264 and 17 trials respectively still open for enrollment."

Answered by AI

What adverse effects could be incurred through KITE-363 usage?

"Our team has rated KITE-363's safety as a 2 because, while there is evidence to back its security profile, there are still no verified reports of this drug being effective."

Answered by AI

How many medical facilities are currently implementing this experiment?

"For this clinical trial, Mayo Clinic in Rochester, Fred Hutchinson Cancer Center in Seattle and Moffitt Cancer Centre in Tampa are the three primary sites. Additionally there is an additional 16 locations enrolled for patient recruitment."

Answered by AI

To what extent is this experiment being conducted with human subjects?

"Currently, this experiment is not recruiting participants. Initially posted on December 15th 2021, the last amendment to it was logged November 23rd 2022. For those interested in other trials for hematological neoplasms there are 264 studies open and 17 related to KITE-363 that accept applicants."

Answered by AI

Has research involving KITE-363 been conducted prior to this?

"The experimental drug KITE-363 was first examined in 2015 at Academisch Medisch Centrum. At present, there have been no completed clinical trials; however, 17 active studies are underway with a sizeable number of them taking place in Rochester, New york."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells
2021. "Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05041309.
~467 spots leftby Dec 2040
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