FDA clears CTA313 trial for progressive MS, autoimmune diseases

Imviva Biotech is cleared to launch a basket Phase 1b trial testing its investigational off-the-shelf CAR T-cell therapy CTA313 in progressive multiple sclerosis (MS) and other B-cell-mediated autoimmune diseases.

The announcement follows the clearance of the company’s investigational new drug (IND) application by the U.S. Food and Drug Administration (FDA).

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Trial to span 3 autoimmune diseases

In addition to progressive MS, the trial will evaluate the therapy’s safety, efficacy, and cellular pharmacokinetics in people with systemic lupus erythematosus — the most common form of lupus — and autoimmune encephalitis, a rare condition in which the immune system mistakenly attacks the brain, causing inflammation.

This basket design is intended to help researchers detect early signs of safety and efficacy across different conditions, while maintaining the flexibility to advance into Phase 2 testing in the most promising indications, the company said in a press release.

Many autoimmune diseases are driven, at least in part, by B-cells, a type of immune cell that normally helps protect the body from infections by producing antibodies. In MS and other autoimmune disorders, however, certain B-cells can contribute to harmful immune attacks against the body’s own tissues.

One emerging strategy for treating these conditions is CAR T-cell therapy, which involves engineering immune T-cells to recognize and destroy cells believed to drive disease. The approach is already approved for several blood cancers and is increasingly being investigated for autoimmune diseases, where the goal is to eliminate abnormal immune cells and potentially reset the immune system.

CTA313 is a CAR T-cell therapy designed to target two proteins found on B-cells and related antibody-producing cells: CD19 and BCMA. By simultaneously targeting both proteins, the therapy is intended to achieve deeper and more durable depletion of the immune cells believed to drive autoimmune disease.

Off-the-shelf design may speed access

Unlike traditional CAR T-cell therapies, which are made individually from a patient’s own cells, CTA313 is an allogeneic therapy produced from healthy donor cells. Because it can be manufactured in advance and stored until needed, it is considered an “off-the-shelf” treatment, potentially allowing patients to receive therapy without the delays associated with collecting and engineering their own cells.

“Our off-the-shelf approach means eligible patients could potentially receive treatment more quickly – without the delays that can be life-threatening for those facing rapidly progressing disease – while also reducing their burden by eliminating the need for apheresis,” Jan Davidson-Moncada, MD, PhD, Imviva’s chief medical officer, said in a company press release.

The therapy was developed using Imviva’s proprietary ANSWER platform, which incorporates additional genetic modifications intended to help donor-derived CAR T-cells evade immune rejection and remain active in the body long enough to exert a therapeutic effect.

“This FDA clearance validates not only CTA313 as a therapeutic candidate, but the broader versatility of our ANSWER platform technology,” Davidson-Moncada added.

CTA313 has already shown encouraging results in an ongoing open-label Phase 1/2 trial in China involving people with systemic lupus erythematosus or lupus nephritis. Results presented earlier this month showed that 50% of evaluable patients achieved remission at one year after a single infusion of the therapy, while 75% had reached a low disease activity state at one year.

The treatment also led to deep depletion of B-cells and sustained reductions in disease-associated autoantibodies. Antibody levels that had fallen after treatment returned to normal after B-cells recovered, while autoimmune anti-dsDNA antibodies remained undetected up to one year.