BOSTON, June 9, 2026
Imviva Biotech announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for CTA313, a dual-targeting CD19/BCMA allogeneic CAR-T cell therapy being developed for patients with B-cell-mediated autoimmune diseases. The clearance enables the initiation of a U.S. Phase 1b clinical study evaluating CTA313 in systemic lupus erythematosus (SLE), progressive multiple sclerosis (MS), and autoimmune encephalitis. The milestone marks Imviva’s expansion into autoimmune therapeutics and advances its proprietary ANSWER™ platform for off-the-shelf cell therapies.
FDA Approval Enables Multi-Disease Phase 1b Clinical Trial
The FDA-cleared Phase 1b study will utilize an innovative basket-trial design to evaluate the safety, efficacy, and cellular pharmacokinetics of CTA313 across multiple autoimmune indications simultaneously. The trial will enroll patients with systemic lupus erythematosus, progressive multiple sclerosis, and autoimmune encephalitis, all conditions driven by abnormal B-cell activity. This clinical strategy is intended to efficiently identify promising therapeutic signals while providing flexibility to advance successful indications into later-stage Phase II development.
Dual-Targeting CAR-T Designed for Autoimmune Disease Treatment
CTA313 is an investigational allogeneic CAR-T therapy engineered to target both CD19 and BCMA, two key proteins expressed on B cells and plasma cells involved in autoimmune disease progression. Derived from healthy donor cells, the therapy incorporates Imviva’s proprietary ANSWER™ inhibitory ligand technology and gene-editing modifications designed to enhance persistence, resist immune rejection, and improve durability of response. By eliminating pathogenic immune cells, CTA313 aims to reset the immune system and potentially provide long-term disease control in patients with severe autoimmune disorders.
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Off-the-Shelf Manufacturing May Improve Patient Access
Unlike traditional autologous CAR-T therapies that require patient-specific manufacturing, CTA313 is produced in advance and stored for immediate use. This off-the-shelf approach eliminates the need for apheresis and significantly reduces treatment delays that can be critical for patients experiencing rapidly progressing autoimmune diseases. Imviva believes the allogeneic platform can improve accessibility, streamline logistics, and expand the potential use of advanced cellular therapies beyond oncology into broader immune-mediated conditions.
Imviva Expands Clinical Pipeline Beyond Oncology
The CTA313 IND clearance represents another important regulatory achievement for Imviva Biotech following previous FDA support for its oncology-focused programs. The company received FDA IND clearance in 2025 and orphan drug designation in 2026 for CTD402, its CD7-targeted therapy for T-cell malignancies. With CTA313 now entering U.S. clinical development, Imviva continues to build a diversified pipeline of next-generation allogeneic CAR-T therapies aimed at addressing major unmet needs in both cancer and autoimmune diseases.
Source: Imviva Biotech press release
