What side effects are associated with this type of intervention?

Common treatments for autoimmune diseases, such as glucocorticoids, IVIG, mycophenolate mofetil, and rituximab, have various side effects. Glucocorticoids can cause hyperglycemia, increased infection risk, bone loss, and neuropsychiatric effects. IVIG may lead to headaches, fever, and allergic reactions. Mycophenolate mofetil can result in gastrointestinal issues and increased infection risk. Rituximab is associated with infusion reactions and potential infections. These treatments aim to modulate the immune response but come with significant side effects that need to be managed carefully.

What prior FDA approvals exist?

Several FDA-approved treatments for autoimmune diseases focus on modulating the immune response. For instance, drugs like rituximab, used in Sjögren's syndrome, and cyclophosphamide, used in multiple sclerosis and anti-GBM disease, work by suppressing the immune system to reduce disease activity. In the context of Type 1 Diabetes (T1D), therapies such as autologous nonmyeloablative stem cell transplantation have shown promise in improving beta-cell function and reducing insulin dependence. These treatments share similarities with the VCTX211 trial, which aims to modulate the immune response and enhance insulin production in T1D patients.

What other types of research exist?

<ol> <li>TTI-621 (SIRPα-IgG1 Fc): This biologic targets the innate immune checkpoint CD47 and has shown activity in relapsed or refractory hematological malignancies and cutaneous T-cell lymphoma. It modulates the immune response and could be a potential alternative for autoimmune conditions involving immune dysregulation.</li> <li>Selpercatinib and Pralsetinib: These selective RET inhibitors have shown efficacy in RET-altered thyroid cancers and could be explored for autoimmune diseases with similar molecular targets.</li> <li>Daratumumab: This monoclonal antibody targets CD38 and has shown promising results in treating immunoglobulin light chain amyloidosis, suggesting potential for other autoimmune conditions.</li> <li>Metformin and Salsalate: These drugs have shown efficacy in slowing the progression of polycystic kidney disease and could be repurposed for autoimmune diseases involving similar pathways.</li> <li>RNAi Therapies (Patisiran, Inotersen): These therapies have shown efficacy in hereditary transthyretin amyloidosis by targeting specific genetic pathways and could be adapted for autoimmune diseases with known genetic components.</li> </ol>

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VCTX211 for Type 1 Diabetes

Phase 1 & 2

Recruiting

Research Sponsored by CRISPR Therapeutics AG

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment for people with Type 1 Diabetes using special insulin-making cells and a delivery device. The cells are edited to avoid immune attacks, and the device helps place them in the body.

Who is the study for?

This trial is for people who have had Type 1 Diabetes (T1D) for at least 5 years and are on a stable diabetes treatment plan. They can't join if they've used immunosuppressants recently, had certain organ transplants, other types of diabetes, gene therapy treatments, or frequent severe unexplained drops in blood sugar.

What is being tested?

The study is testing VCTX211, a new combination product to see how safe and effective it is for treating T1D. It's an early-stage trial where everyone gets the same treatment without any placebos or comparison groups.

What are the potential side effects?

While specific side effects aren't listed here, typical risks may include immune system reactions due to the nature of autoimmune disease treatments like inflammation or allergic responses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: VCTX211 unitExperimental Treatment1 Intervention

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for autoimmune diseases often involve immune-modulating therapies that aim to reduce the abnormal immune response responsible for attacking the body's own tissues. For instance, intravenous immune globulin (IVIG) is used to modulate the immune system by providing antibodies that can neutralize harmful autoantibodies and reduce inflammation. In the context of Type 1 Diabetes (T1D), treatments like the VCTX211 combination product may focus on enhancing insulin production or protecting pancreatic beta cells from immune-mediated destruction. These mechanisms are crucial for patients as they help in managing disease symptoms, preventing organ damage, and improving overall quality of life by restoring normal immune function and preserving essential physiological processes.

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