KITE-363/KITE-753 for B-cell Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the safety and optimal dosage of two experimental treatments, KITE-363 and KITE-753, for individuals with B-cell lymphoma unresponsive to other treatments. B-cell lymphoma is a cancer affecting the white blood cells that fight infections. Participants will receive CAR T-cell therapy, which uses modified T cells to target cancer cells. The trial seeks participants whose B-cell lymphoma has relapsed or is resistant to treatment and who have at least one measurable tumor. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive these new therapies.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that both KITE-363 and KITE-753 demonstrate promising safety results. For KITE-363, earlier studies reached the highest dose level without severe side effects, indicating participants tolerated the treatment well at various doses.
Similarly, real-world data and other studies of CAR T-cell therapies, such as KITE-753, indicate that these treatments generally have manageable safety profiles. While some side effects can occur, they are usually not severe and can be managed with care.
Both treatments remain under study to determine safe dosing, but early findings are encouraging for those considering joining these trials.12345Why are researchers excited about this trial's treatments?
Researchers are excited about KITE-363 and KITE-753 because they offer a new approach to treating B-cell lymphoma using CAR T-cell therapy. Unlike traditional chemotherapy or monoclonal antibodies that target the cancer directly, these treatments involve genetically modifying a patient's own T cells to better recognize and attack cancer cells. This personalized approach means the treatment is specifically tailored to each patient, potentially leading to more effective and long-lasting results. Additionally, by escalating doses during trials, researchers aim to find the optimal balance between effectiveness and safety, offering hope for improved outcomes for patients with relapsed or refractory large B-cell lymphoma.
What evidence suggests that this trial's treatments could be effective for B-cell lymphoma?
Studies have shown that KITE-363, a type of CAR T-cell therapy, works well for people with B-cell lymphoma that has returned or not responded to other treatments. It targets two proteins, CD19 and CD20, on cancer cells, which may help prevent the cancer from returning. One study showed that KITE-363 helped 87% of patients by shrinking their tumors. In this trial, some participants will receive KITE-363, while others will receive KITE-753, another CAR T-cell therapy targeting the CD19 protein, which has shown promising results in extending patient survival. Both treatments in this trial aim to enhance the body's immune response against cancer.12367
Who 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 people with B-cell lymphoma that has come back or hasn't responded to treatment. They must have at least one measurable lesion, good organ and bone marrow function, and no major health issues like heart disease or active infections. People with HIV, hepatitis B/C, recent serious blood clots, CNS disorders, or a history of certain other cancers aren't eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Phase 1a (Dose Escalation)
Participants receive lymphodepleting chemotherapy followed by a single target starting dose of KITE-363 or KITE-753. Additional participants are enrolled based on dose limiting toxicities observed.
Treatment Phase 1b (Dose Expansion)
After dose escalation, additional participants receive lymphodepleting chemotherapy followed by a single dose of KITE-363 or KITE-753 at a tolerable dose level.
Follow-up
Participants are monitored for safety and effectiveness after treatment, transitioning to a long-term follow-up study for 15 years.
What Are the Treatments Tested in This Trial?
Interventions
- Cyclophosphamide
- Fludarabine
- KITE-363
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kite, A Gilead Company
Lead Sponsor