Strong CAR-T persistence: CTA313 achieved >67% Day-28 persistence, exceeding typical allo-CAR-T benchmarks and supports the durability of ImvivaBio’s immune-evasion design. Deep and durable clinical responses: Among 14 evaluable patients with systemic lupus erythematosus (SLE) or lupus nephritis (LN), SRI-4 100%, LLDAS 79%, and DORIS 43% remission were observed at a median 4-month follow-up. All cytokine release syndrome (CRS) cases were all Grade 1 (40%), with no ICANS or GvHD reported. Expanding access through an allogeneic platform: CTA313 is a ready-at-point-of-care therapy that removes the barriers of autologous CAR-T manufacturing, offering a scalable solution that enables global clinical trials and expands access to patients who otherwise cannot receive autologous treatment.

October 29, 2025 – Imviva Biotech, a clinical-stage biotechnology company developing next-generation allogeneic CAR-T cell therapies, today announced the presentation of data from an investigator-initiated trial (IIT) evaluating CTA313 in patients with active systemic lupus erythematosus (SLE) and lupus nephritis (LN).

"The clinical data presented at ACR reinforce the potential of CTA313 as an 'off-the-shelf' therapy to deliver durable, drug-free clinical responses with a single infusion across multiple autoimmune diseases," said Jan Davidson-Moncada, MD, PhD, CMO of Imviva Biotech. "The positive clinical outcomes in SLE and LN patients, including early signs of immunological reset observed in the study, enhance Imviva Biotech's leadership credentials in allogeneic cell therapies. This progress demonstrates our potential to bring groundbreaking treatment solutions to autoimmune disease patients worldwide."

CTA313 Data

This single-arm, open-label, dose-escalation study evaluated the safety and efficacy of CTA313 in patients with SLE/LN. Three dose levels were explored (DL1: 3×106 CAR+ T cells/kg; DL2: 6×106 CAR+ T cells/kg; DL3: 10×106 CAR+ T cells/kg). All patients received lymphodepletion similar to that used for autologous CAR T therapy, consisting of fludarabine (30 mg/m2/day × 3 days) and cyclophosphamide (300 mg/m2/day × 3 days) prior to CTA313 infusion. As of September 20, 2025, 15 patients had been enrolled, including 40% with active or refractory systemic lupus erythematosus (SLE) and 60% with lupus nephritis (LN). The highest SLEDAI-2K score was 23, and 40% of patients had previously been treated with at least one biologic agent.

Key highlights are outlined below:

• Safety: CTA313 was well-tolerated. Cytokine Release Syndrome (CRS) was observed in only 40% of patients, all of which were Grade 1. Only two patients required tocilizumab treatment. No cases of Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS) or Graft-versus-Host Disease (GvHD) were observed at any dose level. Infections were manageable and fully resolved with antimicrobial therapy.

• Efficacy & Cellular Kinetics: With a median follow-up of 4 months, the 14 evaluable patients showed rapid and
  durable disease control.

  • 100% of patients (14/14) achieved an SRI-4 response.

  • 79% of patients (11/14) achieved Lupus Low Disease Activity State (LLDAS).

  • 43% of patients (6/14) achieved Definitions of Remission in SLE (DORIS).

  • Robust in vivo expansion of CAR T cells was observed, with persistence at 28 days in 67% of patients
    and lasting up to 90 days after infusion.

  • Data also showed significant and sustained seroconversion, with marked decreases or normalization
    of anti-dsDNA antibodies and complement C3 levels.

  • Reconstituted B cells displayed a naïve B-cell phenotype, accompanied by a marked reduction in
    memory B cells and plasmablasts , providing early evidence of a potential "immune reset".

"CTA313 demonstrates rapid and sustained disease control in patients with difficult-to-treat systemic lupus erythematosus and lupus nephritis,” said Jan, "The mild CRS profile is especially promising - potentially enabling future outpatient treatment. These findings strongly support expanded development in SLE and broader autoimmune indications."

Ongoing clinical studies are further evaluating CTA313 in patients with other B cell-driven autoimmune diseases, global study is planned for early 2026.

Presentation Details

Title

Preliminary Safety, Efficacy, and Cellular Kinetics of CTA313, a CD19/BCMA Dual-Targeted Universal CAR-T Therapy, for Active Systemic Lupus Erythematosus

Session

Systemic Lupus Erythematosus – Treatment Poster II

Date and Time

Monday, October 27, 10:30 AM - 12:30 PM CT

About CTA313

CTA313 is an allogeneic, CD19/BCMA dual-targeting allogeneic CAR T-cell product derived from healthy donors for the treatment of refractory, active autoimmune diseases. CTA313 is developed based on Imviva Biotech’s proprietary allogeneic CAR-T platform—ANSWER®—which incorporates genetic modifications to prevent graft-versus-host disease (GvHD) and host-versus-graft rejection (HvG). These products can be manufactured in advance and stored for multiple patients, providing an "off-the-shelf" solution for patients in need of CAR-T cell therapy.

Leveraging the ANSWER® platform, Imviva Biotech is actively developing a broad pipeline of allogeneic CAR-T programs. These programs have demonstrated robust and durable persistence of allogeneic CAR-T cells, highlighting strong therapeutic potential in both autoimmune diseases and oncology.

About Imviva Biotech 

Imviva Biotech is a clinical-stage biotechnology company dedicated to developing innovative allogeneic CAR-T cell therapies for patients with cancer and autoimmune diseases. The company's proprietary platform incorporates advanced cell engineering technologies to create off-the-shelf cellular immunotherapies. Imviva’s pipeline includes programs in both oncology and autoimmune indications. 

Forward-Looking Statements

This press release contains forward-looking statements regarding the development and potential of CTA313. These statements involve risks and uncertainties, and actual results may differ materially from those expressed or implied.

Contact

Investor relations: InvestorRelations@Imvivabio.com

Media contact: Media@Imvivabio.com