KITE-753 vs Axicabtagene Ciloleucel for Large B-Cell Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two treatments, KITE-753 and axicabtagene ciloleucel (axi-cel), to determine which is more effective for individuals with large B-cell lymphoma that has recurred or resisted treatment. Both treatments utilize CAR T-cell therapy, a form of immunotherapy that modifies a person's immune cells to enhance their ability to fight cancer. Individuals whose large B-cell lymphoma has returned or not responded after initial treatment may be suitable candidates, particularly if they have measurable disease and have not previously received CAR T-cell therapy. As a Phase 3 trial, this research represents the final step before FDA approval, providing patients an opportunity to access potentially groundbreaking treatments.
Do I have to stop taking my current medications for the trial?
The trial requires a washout period, meaning you must stop taking any prior systemic therapy at least 2 weeks or 5 half-lives before randomization, whichever is shorter. However, the protocol does not specify if you need to stop all current medications, so it's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that KITE-753 was generally well-tolerated by patients with relapsed or refractory B-cell lymphoma. However, about 93% of patients experienced cytokine release syndrome (CRS), causing symptoms like fever and fatigue, with around 9% experiencing more severe cases.
For axicabtagene ciloleucel (axi-cel), research indicates it is usually well-tolerated, though some patients reported significant side effects. In one study, patients experienced more side effects compared to another similar treatment, although the number of deaths unrelated to cancer recurrence was similar.
Both treatments have shown promise in treating large B-cell lymphoma, but they come with side effects that should be discussed with a healthcare provider.12345Why are researchers excited about this trial's treatments?
Researchers are excited about KITE-753 and axicabtagene ciloleucel (axi-cel) because these treatments use a unique approach called CAR T-cell therapy to fight large B-cell lymphoma (LBCL). Unlike traditional chemotherapy and radiation, which target cancer cells broadly, CAR T-cell therapy involves engineering a patient's own immune cells to specifically target and destroy cancer cells. Both KITE-753 and axi-cel are designed to home in on proteins called CD19 and CD20 found on the surface of cancerous B-cells. This targeted mechanism offers the potential for more effective treatment with fewer side effects compared to standard options.
What evidence suggests that this trial's treatments could be effective for large B-cell lymphoma?
This trial will compare KITE-753 with axicabtagene ciloleucel (axi-cel) for treating relapsed or hard-to-treat large B-cell lymphoma (LBCL). Studies have shown that axi-cel can significantly improve survival in people with LBCL. Specifically, patients receiving axi-cel have lived longer and responded better than those receiving standard treatments. In one study, 86% of patients experienced a complete response, meaning their cancer was no longer detectable.
KITE-753, another treatment option in this trial, employs an advanced CAR T-cell method designed to find and destroy cancer cells more effectively. While researchers are still gathering detailed results in humans, early studies suggest it may be effective in treating relapsed or hard-to-treat B-cell lymphoma, with initial findings showing promising reductions in cancer cells.13678Who Is on the Research Team?
Kite Study Director
Principal Investigator
Kite, A Gilead Company
Are You a Good Fit for This Trial?
This trial is for adults with large B-cell lymphoma that has come back or not responded after their first treatment. Participants must have had certain chemotherapy drugs before, have measurable disease, and no other treatments (except steroids or local radiation) since their last therapy.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Lymphodepleting Chemotherapy
Participants receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide
Treatment
Participants receive a single infusion of anti-CD19/CD20 CAR T cells (KITE-753 or axi-cel)
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants are monitored for event-free survival, progression-free survival, and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- Axicabtagene Ciloleucel
- KITE-753
Trial Overview
The study compares two CAR T-cell therapies: KITE-753 (an experimental treatment) versus axicabtagene ciloleucel (axi-cel), both given after standard pre-treatment with cyclophosphamide and fludarabine. Patients are randomly assigned to one of the two groups.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants with r/r LBCL will receive the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine and cyclophosphamide. * A single infusion at a target dose of anti-cluster of differentiation 19 (CD19)/CD20 chimeric antigen receptor (CAR) T cells/kg of KITE-753.
Participants with r/r LBCL will receive the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine and cyclophosphamide. * A single infusion at a target dose of anti-CD19/CD20 CAR T cells/kg of axi-cel.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kite, A Gilead Company
Lead Sponsor
Citations
Outcomes of second‐line axicabtagene ciloleucel for large B ...
Outcomes were favorable in patients aged ≥70 years, supporting the use of 2 L CAR T in older fit patients. INTRODUCTION. CD19 CAR T‐cell therapy ...
Survival with Axicabtagene Ciloleucel in Large B-Cell ...
Axi-cel as second-line treatment for patients with early relapsed or refractory large B-cell lymphoma resulted in significantly longer overall survival than ...
3.
ashpublications.org
ashpublications.org/blood/article/145/20/2303/535581/Three-year-follow-up-analysis-of-first-lineThree-year follow-up analysis of first-line axicabtagene ...
First-line axi-cel demonstrated an 86% complete response rate and 3-year PFS rate of 75% in efficacy-evaluable patients with high-risk LBCL.
Real-World Outcomes of Axicabtagene Ciloleucel for ... - PMC
CD19 CAR T-cell therapy has significantly improved the survival of patients with relapsed or refractory large B cell lymphoma (R/R LBCL) and is ...
NCT03391466 | Study of Effectiveness of Axicabtagene ...
The goal of this clinical study is to assess whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line ...
6.
ashpublications.org
ashpublications.org/blood/article/144/Supplement%201/609/530637/Predictors-of-Early-Safety-Outcomes-withPredictors of Early Safety Outcomes with Axicabtagene ...
Predictors of Early Safety Outcomes with Axicabtagene Ciloleucel (axi-cel) in Patients with Relapsed or Refractory (R/R) Large B-Cell Lymphoma ( ...
Second-Line Axicabtagene Ciloleucel Therapy Improves ...
The ZUMA-1 study showed good responses with axicabtagene ciloleucel in patients with refractory large B-cell lymphoma, resulting in a 5-year overall survival ( ...
Safety and efficacy of axicabtagene ciloleucel in refractory ...
We provide an overview of axi-cel therapy, including efficacy and safety data, along with a practical discussion of current treatment considerations.
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