CREATE Medicines Receives Approval to Initiate First-in-Human Phase 1/2 Clinical Trial of In Vivo CAR-T Candidate CRT-402 for Autoimmune Diseases

• Australian HREC approval clears the initiation of CREATE's first-in-human Phase 1/2 study evaluating CRT-402 in patients with systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and idiopathic inflammatory myopathies (IIM).
• HREC approval represents the final regulatory step required to begin patient enrollment in Australia.

CAMBRIDGE, Mass., July 30, 2026 /PRNewswire/ -- CREATE Medicines, Inc. ("CREATE"), a clinical-stage biotechnology company pioneering in vivo multi-immune programming, today announced that it has received Human Research Ethics Committee (HREC) approval in Australia to begin its first-in-human Phase 1/2 clinical trial of CRT-402, CREATE's lead in vivo CAR-T candidate for the treatment of autoimmune diseases. The study marks CREATE's expansion into autoimmune disease and represents the company's fourth program from the platform to enter the clinic, and the first outside oncology.

CRT-402 is a CD19-targeted, in vivo CAR-T therapy that reprograms a patient's own T cells directly within the body to deplete autoreactive B cells and drive disease into remission. Because it works in vivo, CRT-402 removes the need for the ex vivo cell manufacturing required by conventional CAR-T therapies, greatly expanding access to this remission-inducing, B cell depleting approach for patients with autoimmune diseases.

"Our clinical experience in oncology has demonstrated the potential of CREATE's platform to deliver in vivo CAR therapies directly in patients, and CRT-402 represents a natural extension of that platform into autoimmune disease," said Daniel Getts, PhD, Chief Executive Officer and Co-founder of CREATE Medicines. "The preclinical data supporting CRT-402 are highly encouraging, and we are grateful to the HREC for its thoughtful and thorough review. Advancing CRT-402 into the clinic is an important milestone for CREATE and for patients living with autoimmune disease, and further validates the breadth of our in vivo CAR platform across multiple therapeutic areas."

"Patients with B cell driven autoimmune diseases, including myositis, urgently need therapies that can deliver deep and durable remission," said Professor Merrilee Needham, Foundation Chair in Neurology at Fiona Stanley Hospital and principal investigator for the CRT-402 trial. "CRT-402's potential to achieve deep B cell depletion in vivo, and to reach more patients than conventional cell therapies, is what makes this trial so important. I look forward to evaluating it in the clinic and working with the CREATE team over the coming months."

About CRT-402
CRT-402 is CREATE Medicines' lead in vivo CAR-T candidate in autoimmune disease, a CD19-targeted in vivo CAR-T therapy delivered using the company's proprietary mRNA-LNP platform. The therapy is designed to enable deep B cell depletion and immune reset while offering the potential advantages of repeat dosing and an off-the-shelf administration paradigm. In preclinical studies, CRT-402 demonstrated deep and durable B cell depletion in nonhuman primates.

About CREATE Medicines
CREATE Medicines is a clinical-stage biotech pioneering in vivo CAR therapy. Its proprietary mRNA-LNP platform directly programs immune cells inside the body to deliver scalable, repeat-dose, off-the-shelf immunotherapies. With proven human validation, CREATE is advancing a pipeline of in vivo CAR therapies to transform outcomes in cancer and autoimmune diseases.

For more, visit createmedicines.com. Follow us on LinkedIn, X (Twitter), and Bluesky.

Business Development: [email protected]

Media Contact:
Jude Gorman / Kiki Torpey
Collected Strategies
[email protected]

Investor Contact:
Brian Korb
Astr Partners
[email protected]
+1 (917) 653-5122

SOURCE CREATE Medicines, Inc.