Categories: Science

FDA clears IND for clinical trial testing switchable CAR-T therapy in patients with autoimmune diseases, without chemotherapy


Calibr-Skaggs Institute for Innovative Medicines, the drug discovery division of Scripps Research, announced today that the FDA has cleared their investigational new drug (IND) application to study switchable chimeric antigen receptor T cell (sCAR-T) therapy (CLBR001 + SWI019) in patients with autoimmune conditions. Patient recruitment for the phase 1 trial will begin soon (NCT06913608). The phase 1 clinical trial will evaluate the safety and efficacy of CLBR001 + SWI019 in patients with myositis, systemic sclerosis, lupus and rheumatoid arthritis, with the potential to expand to other indications in the future. Calibr-Skaggs’ novel sCAR-T therapy is designed to reduce side effects and patient burden associated with prior lymphodepletion treatments required for traditional CAR-T approaches — an important issue for rheumatologists and patients.

Autoimmune diseases are often chronic conditions that affect up to ~15 million people in the U.S. and up to 12% of the global population. CAR-T cell therapy has demonstrated curative potential in select autoimmune diseases by creating a system-wide immune ‘reset’, improving a patient’s quality of life, and reducing the need for life-long immune suppressants. However, conventional CAR-T cell therapies require lymphodepletion — a chemotherapy procedure used to eliminate existing immune cells to ensure the CAR-T cells can effectively expand. Further, this procedure can lead to increased risk of infection and severe side effects. CLBR001 + SWI019 was designed to avoid these issues by eliminating the need for lymphodepletion, reducing side effects and potentially making treatment accessible to a broader patient population.

“Patients with chronic autoimmune diseases need curative options that do not require life-long immunosuppressive therapy to manage their condition,” says Travis Young, vice president of biologics at Calibr-Skaggs. “Our CLBR001 + SWI019 cell therapy has the potential to transform the treatment paradigm for patients by eliminating chemotherapy-associated risks.”

Calibr-Skaggs’ Chief Medical Officer Chan Beals says, “Successfully establishing safety and efficacy of CLBR001 + SWI019 for conditions like lupus and rheumatoid arthritis could pave the way for broader therapeutic use in other autoimmune diseases, offering new hope to many more patients in the future.”

Patient enrollment for the clinical trial is anticipated to begin soon.

About CLBR001 + SWI019 Switchable CAR-T

Calibr-Skaggs’ CLBR001 + SWI019 switchable CAR-T cell therapy differs from conventional CAR-T approaches by leveraging two components, a sCAR-T cell (CLBR001) and a protein-based biologic “switch” (SWI019) that targets CD19-positive B cells. CLBR001 + SWI019 has already demonstrated promising results in treating patients with B cell malignancies, with the ability to shorten the duration of adverse effects such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), and preclinical work has demonstrated the unique ability to work without lymphodepletion. In early-stage trials, CLBR001 cells expanded in patients to higher levels in peripheral blood compared to approved CAR-T cell products, with robust persistence.



Source link

24timenews.com

Recent Posts

RCB Star Tim David Slams 3 Sixes In A Row Against Punjab Kings, Leaves Everyone Stunned – Watch

Pressure to score quick runs and clever bowling by Punjab Kings restricted Royal…

2 hours ago

Ford Already Has 40 Recalls This Year

We are just a few weeks into spring, and Ford already has a truckload of…

2 hours ago

A wearable smart insole can track how you walk, run and stand

A new smart insole system that monitors how people walk in real time could help…

2 hours ago

Atomfall’s Game Pass Launch a ‘Huge Success’, Rebellion CEO Says

Atomfall, the action-survival game from Rebellion Developments, launched on PC, PlayStation and Xbox platforms last…

2 hours ago

Royal Challengers Bengaluru vs Punjab Kings LIVE Scorecard, IPL 2025 LIVE Updates: RCB vs PBKS Match Starts Losing Overs. Cut-Off Time Is…

RCB vs PBKS Live: Let's take a look at the likely 12s!RCB (probable): Phil Salt,…

12 hours ago

How Ferdinand Piëch Invented the Bugatti Veyron

A legend of the automotive industry, even six years after his death: Ferdinand Karl Piëch,…

12 hours ago