KITE-363 for Lupus
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called KITE-363 for individuals with difficult-to-treat autoimmune diseases, such as lupus and systemic sclerosis. The main goal is to determine the right dose and assess its safety and effectiveness. Participants will first receive chemotherapy, followed by the KITE-363 treatment, to evaluate its efficacy. This trial may suit those who have tried other treatments without much success and continue to experience moderate to severe symptoms. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should have been refractory or intolerant to certain treatments, which suggests that you might need to continue some existing medications. It's best to discuss this with the trial coordinators for specific guidance.
Is there any evidence suggesting that KITE-363 is likely to be safe for humans?
Research shows that CAR T-cell therapy, such as KITE-363, holds promise for treating autoimmune diseases. In past studies, CAR T-cells treated severe lupus, and patients often experienced rapid and lasting symptom improvement. These treatments aim to offer an alternative to steroids, which is crucial due to the many side effects associated with steroids.
Regarding safety, researchers are still testing KITE-363 to determine the optimal dose and assess patient tolerance. As this study is in an early phase, it primarily focuses on understanding safety and side effects. While detailed information on KITE-363 is not yet available, CAR T-cells have generally been well-tolerated in similar contexts. However, participants might encounter common side effects of CAR T-cell therapies, such as fever or fatigue.
Participating in an early-phase trial means the treatment is still under safety evaluation, so less information is available compared to more established treatments. However, it also offers access to potentially cutting-edge therapy.12345Why do researchers think this study treatment might be promising for lupus?
Unlike the standard treatments for lupus, which often involve immunosuppressive drugs, KITE-363 offers a new approach using CAR T-cell therapy. This treatment is distinctive because it harnesses the power of genetically engineered T cells to specifically target and eliminate problematic immune cells, potentially offering a more precise attack on the disease. Researchers are excited about KITE-363 because it could provide a more targeted and durable response, reducing the need for long-term medication and potentially leading to better management of lupus symptoms.
What evidence suggests that KITE-363 might be an effective treatment for lupus?
Research has shown that CAR-T cell treatments, such as KITE-363, can quickly and effectively reduce symptoms in severe lupus cases. In this trial, participants will receive KITE-363, which targets specific proteins, CD19 and CD20, on certain immune cells, reducing their harmful activity. Early studies suggest this treatment could manage autoimmune diseases without steroids. These findings indicate that KITE-363 might help control lupus symptoms by altering immune system function.12346
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 adults aged 18-75 with refractory autoimmune diseases like Lupus and Systemic Sclerosis. Participants must have moderate to severe active disease, not responding well to standard treatments, and meet specific criteria such as having a certain type of lupus nephritis or evidence of active disease.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1a: Dose Escalation
Participants receive lymphodepleting chemotherapy followed by 2 dose escalations of KITE-363 to determine the recommended dose for Phase 1b
Phase 1b: Dose Expansion
Participants receive lymphodepleting chemotherapy followed by the recommended dose of KITE-363 to evaluate safety and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- KITE-363
Trial Overview
The study tests KITE-363's safety, tolerability, dosing, and preliminary efficacy in two phases. Phase 1a focuses on finding the right dose based on safety; Phase 1b looks at how safe and effective it is for treating autoimmune diseases.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants with refractory autoimmune diseases will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed Phase 1ab recommended dose of KITE-363 CAR T cells.
Participants with refractory autoimmune diseases will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by 2 dose escalations of KITE-363 chimeric antigen receptor (CAR) transduced autologous T cells to find the Phase 1b recommended dose.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kite, A Gilead Company
Lead Sponsor
Citations
NCT07038447 | A Study of KITE-363 in Participants With ...
The goal of this clinical study is to learn more about the study drug KITE-363, to establish dosing, tolerability, safety, and preliminary efficacy of KITE-363 ...
A Study of KITE-363 in Participants With Refractory ...
The goal of this clinical study is to learn more about the study drug KITE-363, to establish dosing, tolerability, safety, and preliminary ...
CAR-T cells for treating systemic lupus erythematosus
CAR-T cells show rapid and prolonged remission in severe lupus patients. CAR-T cells may offer a steroid-free alternative in several autoimmune diseases.
ANZCTR - Registration
Safety and efficacy of Kite-363 will be evaluated in participants with Systemic Lupus Erythematosus with or without Lupus Nephritis; Systemic ...
5.
acrabstracts.org
acrabstracts.org/abstract/kite-363-an-autologous-anti-cd19-cd20-car-t-product-for-the-treatment-of-autoimmune-rheumatic-diseases/KITE-363: An Autologous Anti-CD19/CD20 CAR-T Product ...
Patient-derived KITE-363 T cell products exhibited high expression of both the anti-CD19 and anti-CD20 CARs and demonstrated CAR- and antigen-specific T-cell ...
CAR T-cell therapy in systemic lupus erythematosus
The authors described the use of chimeric CAR T cells in patients with SLE who were refractory to standard immunosuppressive treatment.
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