CAMBRIDGE, Mass., July 30, 2026
CREATE Medicines has received Human Research Ethics Committee (HREC) approval in Australia to initiate its first-in-human Phase 1/2 clinical trial evaluating CRT-402, the company’s lead in vivo CAR-T therapy for the treatment of autoimmune diseases. The HREC authorization represents the final regulatory milestone required before patient enrollment can begin in Australia and marks CREATE’s expansion beyond oncology into autoimmune medicine. The Phase 1/2 study will evaluate CRT-402 in patients with systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and idiopathic inflammatory myopathies (IIM). The announcement also represents the fourth clinical program generated from CREATE’s proprietary in vivo multi-immune programming platform and highlights the growing clinical momentum behind next-generation off-the-shelf CAR-T therapies designed to simplify manufacturing while expanding patient access to advanced cell-based immunotherapies.
First-in-Human Trial Targets Autoimmune Diseases with In Vivo CAR-T Therapy
The newly approved Phase 1/2 clinical trial will evaluate CRT-402, a CD19-targeted in vivo CAR-T therapy designed to directly reprogram a patient’s own immune cells inside the body. Unlike traditional ex vivo CAR-T therapies, which require complex laboratory manufacturing and individualized cell processing before treatment, CRT-402 eliminates the need for external cell manufacturing by programming immune cells in vivo following administration. The therapy aims to selectively eliminate autoreactive B cells, which play a central role in several autoimmune diseases, enabling deep immune system resetting and potentially driving long-term disease remission. The study will initially enroll patients suffering from systemic lupus erythematosus, systemic sclerosis, and idiopathic inflammatory myopathies, diseases that continue to present significant unmet medical needs despite advances in immunology and biologic therapies. The approval represents an important step toward evaluating whether in vivo CAR-T technology can deliver effective immune reprogramming with greater scalability and broader patient accessibility than conventional CAR-T approaches.
Proprietary mRNA-LNP Platform Expands CAR-T Innovation
CRT-402 is powered by CREATE Medicines’ proprietary mRNA-LNP (messenger RNA-lipid nanoparticle) platform, an innovative delivery system designed to program immune cells directly inside the patient. The technology combines the flexibility of mRNA therapeutics with targeted lipid nanoparticle delivery, allowing repeated dosing while supporting an off-the-shelf treatment model that avoids many logistical challenges associated with personalized CAR-T manufacturing. In preclinical studies, CRT-402 demonstrated deep and durable B-cell depletion in non-human primates, supporting its advancement into human clinical evaluation. The company’s platform has already demonstrated clinical validation in oncology, and the launch of the autoimmune disease program significantly broadens the potential application of in vivo CAR-T technology across multiple therapeutic areas. By removing manufacturing bottlenecks and simplifying treatment delivery, CREATE aims to make advanced cellular immunotherapies more accessible to larger patient populations worldwide.
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Clinical Expansion Strengthens Next-Generation Immunotherapy Pipeline
The initiation of the CRT-402 Phase 1/2 trial marks an important milestone in CREATE Medicines’ strategy to build a diversified pipeline of in vivo CAR-T therapies targeting both cancer and autoimmune diseases. The company’s proprietary platform is designed to deliver scalable, repeat-dose immunotherapies capable of transforming treatment outcomes through direct immune programming inside the body. Investigators believe deep B-cell depletion achieved through CRT-402 could provide durable remission for patients living with severe autoimmune disorders while overcoming limitations associated with current treatment approaches. The Australian trial also reflects increasing global interest in next-generation cell and gene therapies, particularly technologies capable of expanding patient access while reducing manufacturing complexity and treatment costs. As enrollment begins, the study will generate important clinical data that could further establish in vivo CAR-T therapy as a promising new therapeutic class for autoimmune disease management and future precision immunology.
Source: CREATE Medicines press release
