CAR T-Cell Therapy for Multiple Sclerosis
Trial Summary
What is the purpose of this trial?
A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects with Refractory Primary and Secondary Progressive Multiple Sclerosis
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify if you need to stop taking your current medications. However, since it involves CAR T-Cell therapy, it's possible that some medications might need to be adjusted. Please consult with the trial coordinators for specific guidance.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the idea that CAR T-Cell Therapy for Multiple Sclerosis is an effective treatment?
The available research does not provide specific data on CAR T-Cell Therapy for Multiple Sclerosis. Instead, it discusses other treatments like autologous hematopoietic stem cell transplantation (HSCT) and cell-based therapies. These treatments have shown some promise in managing multiple sclerosis by resetting the immune system and potentially offering neuroprotection. However, they also come with safety concerns and unresolved questions. Without specific data on CAR T-Cell Therapy, it's difficult to compare its effectiveness to these other treatments.12345
What safety data exists for CAR T-Cell Therapy in treating Multiple Sclerosis?
CAR T-Cell Therapy, including treatments like KYV-101 and Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, has been associated with several safety concerns. Key adverse events include severe cytokine release syndrome (sCRS) and severe neurological toxicities (sNTX), as identified in a cross-study safety analysis involving 1,926 subjects from various trials. The use of gammaretrovirus vectors with CD28 sequences was linked to higher rates of sNTX. Management strategies, such as cytokine-directed therapies and corticosteroids, have been associated with reduced sCRS rates. Cardiovascular events, including arrhythmias and heart failure, have also been reported, with a higher mortality rate observed in patients experiencing these events. Overall, while CAR T-Cell Therapy shows promise, it carries significant risks that require careful management.678910
Is CAR T-Cell Therapy generally safe for humans?
CAR T-Cell Therapy has shown potential for severe side effects, including cytokine release syndrome (a severe immune reaction) and neurological toxicities (nerve-related side effects). Cardiovascular events like arrhythmias (irregular heartbeats) and heart failure have also been reported, with a higher risk of these events when other side effects are present.678910
Is the treatment KYV-101 a promising treatment for Multiple Sclerosis?
How is the treatment KYV-101 different from other treatments for multiple sclerosis?
KYV-101 is a unique treatment for multiple sclerosis because it uses CAR T-cell therapy, which involves engineering the patient's own immune cells to specifically target and suppress harmful immune responses. This approach is different from traditional treatments that generally suppress the immune system without targeting specific cells.1112131415
Research Team
MD
Principal Investigator
Kyverna Therapeutics, Inc.
Eligibility Criteria
This trial is for people with a tough form of multiple sclerosis (MS) that hasn't improved after other treatments. Participants must have been diagnosed with primary or secondary progressive MS and shown worsening disability despite previous anti-CD20 mAB therapy.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive KYV-101 CAR T cells with lymphodepletion conditioning or anti-CD20 mAb
Follow-up
Participants are monitored for safety, efficacy, and pharmacokinetics of KYV-101
Treatment Details
Interventions
- KYV-101
KYV-101 is already approved in United States for the following indications:
- Refractory Lupus Nephritis
- Stiff-Person Syndrome
- Myasthenia Gravis
- Diffuse Cutaneous Systemic Sclerosis (Scleroderma)
- Primary and Secondary Progressive Multiple Sclerosis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kyverna Therapeutics
Lead Sponsor