52 Participants NeededMy employer runs this trial

KITE-363 for Multiple Sclerosis

Recruiting at 7 trial locations
MI
Overseen ByMedical Information
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Kite, A Gilead Company
Must be taking: Immunosuppressants
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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 specific neurological autoimmune diseases, such as multiple sclerosis (MS), myasthenia gravis (MG), and chronic inflammatory demyelinating polyneuropathy (CIDP). The main goal is to assess the safety and effectiveness of KITE-363 and to determine the optimal dose. Potential participants include those with MS who have not responded well to other treatments and have ongoing symptoms like difficulty walking or muscle weakness. As a Phase 1 trial, participants will be among the first to receive KITE-363, aiding researchers in understanding how the treatment works in people.

Do I have to stop taking my current medications for the trial?

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 KITE-363 is likely to be safe for humans?

Research has shown that KITE-363, a new treatment being tested for autoimmune neurologic diseases like multiple sclerosis, has been generally safe in past studies. In early trials, participants did not experience serious side effects that would prevent dose escalation, indicating that the treatment was well-tolerated at the tested doses.

Before human testing, research also showed promising results, suggesting that CAR T-cell therapy, the type of treatment KITE-363 is, might help manage inflammation in the brain and spinal cord. These findings encourage those considering participation in a clinical trial for KITE-363. However, since this is an early-stage trial, further testing will provide a clearer picture of its safety.12345

Why do researchers think this study treatment might be promising for multiple sclerosis?

Most treatments for multiple sclerosis (MS) involve drugs that mainly aim to reduce inflammation or modify the immune system, like interferons or monoclonal antibodies. But KITE-363 works differently, by using chimeric antigen receptor (CAR) T cells, which are engineered to specifically target and destroy immune cells that mistakenly attack the nervous system. This approach is unique because it offers a more targeted attack on the condition, potentially reducing the frequency and severity of relapses. Researchers are excited because this could mean more precise treatment with fewer side effects compared to existing therapies.

What evidence suggests that KITE-363 might be an effective treatment for multiple sclerosis?

Research has shown that KITE-363 could be a promising treatment for multiple sclerosis (MS) and other autoimmune diseases. This therapy uses modified immune cells to target specific proteins involved in these diseases, potentially reducing symptoms. In studies on other conditions, such as large B-cell lymphoma, KITE-363 demonstrated high success rates and long-lasting benefits, suggesting it might also be effective for autoimmune diseases like MS. Early research in MS indicates that this therapy could help manage both sudden flare-ups and ongoing inflammation in the brain and spinal cord. These findings offer hope that KITE-363 could provide a new way to manage autoimmune diseases. Participants in this trial will receive KITE-363 in two phases: Phase 1a involves dose escalation to determine the optimal dose, and Phase 1b involves dose expansion using the recommended dose from Phase 1a.12346

Who Is on the Research Team?

KS

Kite Study Director

Principal Investigator

Kite, A Gilead Company

Are You a Good Fit for This Trial?

This trial is for adults with certain autoimmune nerve diseases (like multiple sclerosis, myasthenia gravis, or CIDP) who have not improved with standard treatments. Participants must be ambulatory, have stable disease without recent relapses, and meet specific diagnostic criteria. They also need to agree to use contraception if applicable.

Inclusion Criteria

My latest brain MRI showed no signs of active lesions.
I can walk without aid or rest for at least 200 meters.
I haven't had any symptoms or relapses for at least 2 years.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1a: Dose Escalation

Participants receive lymphodepleting chemotherapy followed by infusion of KITE-363 CAR T cells at escalating doses to determine the recommended dose for Phase 1b.

12 weeks
Multiple visits for dose escalation and monitoring

Phase 1b: Dose Expansion

Participants receive the recommended dose of KITE-363 CAR T cells determined from Phase 1a.

24 weeks
Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years
Periodic visits for long-term monitoring

What Are the Treatments Tested in This Trial?

Interventions

  • KITE-363

Trial Overview

The study tests a new treatment called KITE-363 in people whose autoimmune neurologic diseases haven't responded well to other therapies. Before receiving KITE-363, participants get fludarabine and cyclophosphamide. The trial has two phases focused on safety and finding the best dose.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Phase 1b: KITE-363 (Dose Expansion)Experimental Treatment3 Interventions
Group II: Phase 1a: KITE-363 (Dose Escalation)Experimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kite, A Gilead Company

Lead Sponsor

Trials
45
Recruited
4,300+

Citations

NCT07304154 | A Study Evaluating the Safety and Efficacy ...

The goals of this clinical study are to learn more about the study drug KITE-363, by evaluating its safety, tolerability and efficacy in participants with ...

A Study of KITE-363 in Participants With Refractory ...

The primary objectives of this study are: Phase 1a: To evaluate the safety and tolerability of KITE-363 in participants with autoimmune disease.

KITE-363 Shows Potential As a Next-Generation CAR T- ...

KITE-363 generated high response rates in the highly refractory CAR T-cell therapy–naive LBCL population at dose level 3 (n = 23). In this group ...

ANZCTR - Registration

This is a primary outcome. To evaluate the preliminary efficacy of KITE-363 in participants with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).

Kite's Next Generation Bicistronic CAR T Cell Therapies ...

Meanwhile, results for KITE-363 revealed that at a median follow-up of 17.5 months, there was a durable benefit at the highest dose level (2 ...

Abstract Details

This preclinical study evaluated KITE-363, a dual-targeting anti-CD19/CD20 CAR T-cell therapy in patients with myasthenia gravis (MG) or multiple sclerosis (MS) ...