SC291 CAR T-Cell Therapy Fast Tracked for Relapsed/Refractory SLE
Sana Biotechnology’s SC291 chimeric antigen receptor T-cell therapy is being developed to treat relapsed/refractory systemic lupus erythematosus, including extrarenal lupus and lupus nephritis.
Dhaval Patel, MD, PhD
(Credit: Sana Bio)
A version of this article first appeared on our sister site, HCPLive.
Sana Biotechnology’s investigational chimeric antigen receptor (CAR) T-cell therapy, known as SC291, has been granted fast track designation by the FDA for the treatment of relapsed or refractory systemic lupus erythematosus (SLE), including both lupus nephritis and extrarenal lupus.1
Dhaval Patel, MD, PhD, the chief scientific officer of Sana, said in a statment that the company was pleased to receive the designation, noting that it “highlights the need for new treatment options for patients with relapsed/refractory SLE."
The therapy is a CD19-directed, hypoimmune (HIP)-modified allogeneic CAR T agent, designed as an off-the-shelf treatment. "As a HIP-modified allogeneic CAR T therapy with a scaled manufacturing process that produces hundreds of patient doses per manufacturing run, SC291 has the potential to serve as a universal off-the-shelf therapy that can address this large unmet need. We look forward to sharing initial data from the ongoing GLEAM trial," Patel said.1
SC291 is currently under investigation in the aforementioned phase 1 GLEAM trial (NCT06294236), which is evaluating its safety, tolerability, and potential clinical benefits in an estimated population of 36 patients with B-cell-mediated autoimmune conditions.1 The trial is assessing a single dose in patients pretreated with a standard regimen including cyclophosphamide and fludarabine.
GLEAM Trial Overview
The ongoing GLEAM study is a 24-month clinical trial designed to assess the safety profile of SC291. Secondary end points include changes in renal function, measured by estimated glomerular filtration rate, and proteinuria, assessed by urine protein creatinine ratio. Additional outcomes include duration of remission without medication, time to disease relapse, and changes in disease activity using various metrics such as the Systemic Lupus Erythematosus Disease Activity Index 2000 and Birmingham Vasculitis Activity Score version 3. Levels of SC291 CAR+ T cells in blood samples will also be monitored over the 24-month period.¹
Initial data from this trial are expected in 2025. The therapy aims to address the unmet needs of patients with autoimmune conditions that do not respond adequately to conventional treatments.¹
The fast track designation for SC291 reflects an ongoing need for innovative therapies to treat SLE, particularly in cases where current treatments fail to achieve satisfactory disease control. The data from ongoing trials, including the GLEAM and PHOENYCS GO studies, may contribute to the development of more targeted and effective options for managing SLE, particularly as more therapies are evaluated.
Other SLE Data From ACR
SLE and other autoimmune diseases have emerged as an area of focus for CAR-T therapeutic development in recent years. While on-site at the 2024 American College of Rheumatology (ACR) Convergence, held November 14 to 19 in Washington, DC, CGTLive®'s sister site HCPLive® spoke with Georg Schett, MD, vice president of research and chair of internal medicine at the University of Erlangen – Nuremberg, who presented data from 2 studies evaluating CD19-directed CAR-T therapies in patients with a variety of refractory autoimmune and rheumatic diseases—the CASTLE basket study and a phase 1 clinical trial for CC-97540, in development from Bristol Myers Squibb.2,3
Schett, among other topics, noted that the "development of new technologies in CAR T-cells is very important, and [the next-generation] fast manufacturing [CC97540 uses] is very exciting because it's only 5 days, and you actually need much fewer cells to be infused into a patient with this fast manufacturing method, with a similar expansion of the cells as with the original method. So I think that's very exciting and it's, obviously, also important if there's a shorter duration in the turnaround time and less need for production space, because it's just shorter."
Another CD19-directed CAR-T therapy, Cabaletta Bio’s CABA-201, had data presented at ACR showing effect responses or possible emerging responses in some patients treated in the phase 1/2 RESET-SLE clinical trial (NCT06121297) for SLE and lupus nephritis, the phase 1/2 RESET-Myositis clinical trial (NCT06154252) for active idiopathic inflammatory myopathy (IIM), and the phase 1/2 RESET-SSc clinical trial (NCT06328777) in systemic sclerosis (SSc).4
