What side effects are associated with this type of intervention?

CAR T-cell therapies, such as brexucabtagene autoleucel, are associated with serious and potentially life-threatening side effects, including cytokine release syndrome (CRS), which can cause fever, nausea, headache, rash, rapid heartbeat, low blood pressure, and trouble breathing. Neurological toxicities are also common, manifesting as confusion, seizures, or severe headaches. General side effects of chemotherapy include nausea, vomiting, hair loss, fatigue, and increased risk of infections due to lowered white blood cell counts. Radiation therapy can cause skin irritation, fatigue, and localized side effects depending on the treatment area. Immunotherapy, such as checkpoint inhibitors, can lead to immune-related adverse events like colitis, hepatitis, endocrinopathies, and pneumonitis.

What prior FDA approvals exist?

The FDA has approved several CAR T-cell therapies for cancer treatment. Axicabtagene ciloleucel (Yescarta) is approved for certain types of large B-cell lymphoma. Tisagenlecleucel (Kymriah) is approved for acute lymphoblastic leukemia (ALL) in patients up to 25 years old and for certain types of large B-cell lymphoma. Brexucabtagene autoleucel (Tecartus) is approved for mantle cell lymphoma. These therapies involve the genetic modification of a patient's T-cells to express chimeric antigen receptors (CARs) that target specific cancer antigens, leading to the destruction of cancer cells.

What other types of research exist?

Promising novel alternatives to CAR T-cell therapies for cancer patients in 2024 include: 1) Immune checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1, and anti-CTLA-4 antibodies) which enhance the immune system's ability to fight cancer. 2) Targeted therapies such as selective RET inhibitors (e.g., selpercatinib, pralsetinib) for RET-altered cancers. 3) Antisense oligonucleotides and RNA interference therapies targeting specific genetic mutations in cancers, such as those being developed for Huntington's disease. 4) Bispecific T-cell engagers (BiTEs) that direct T-cells to cancer cells. 5) Novel monoclonal antibodies and antibody-drug conjugates (ADCs) that deliver cytotoxic agents directly to cancer cells.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

CAR T-cell therapies involve genetically modifying a patient's T-cells to express chimeric antigen receptors (CARs) that specifically target cancer cell antigens, leading to the direct destruction of cancer cells. This personalized approach harnesses the body's immune system to fight cancer more effectively. Other common treatments include immune checkpoint inhibitors, which block proteins that prevent T-cells from attacking cancer cells, and targeted therapies that inhibit specific molecules involved in cancer cell growth and survival. These mechanisms are vital for cancer patients as they offer tailored treatment options that can improve outcomes and reduce side effects compared to traditional therapies.

Find a Location

Who is running the clinical trial?

Kite, A Gilead CompanyLead Sponsor

44 Previous Clinical Trials

3,401 Total Patients Enrolled

Kite Study DirectorStudy DirectorKite, A Gilead Company

29 Previous Clinical Trials

2,759 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

~467 spots leftby Dec 2040

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