CREATE Medicines to Launch First Phase 1/2 In Vivo Trial of CAR-T Candidate CRT-402 for Autoimmune Diseases in Australia
The approval enables CREATE to start enrolling Australian patients with lupus, systemic sclerosis, and inflammatory myopathies in a first-in-human study of its in vivo CD19-targeted CAR-T therapy, designed to deplete harmful B cells without the complex manufacturing of traditional cell therapies.
Key Points
- CREATE Medicines has received HREC approval in Australia to begin a first-in-human Phase 1/2 trial of CRT-402 in autoimmune diseases.
- The study will evaluate CRT-402 in patients with systemic lupus erythematosus, systemic sclerosis, and idiopathic inflammatory myopathies.
- CRT-402 is a CD19-targeted in vivo CAR-T candidate designed to reprogram T cells inside the body, avoiding conventional ex vivo manufacturing.
CREATE Medicines, a Massachusetts-based biotech company, has received approval from the Human Research Ethics Committee in Australia to begin its first-in-human Phase 1/2 clinical trial of CRT-402 for autoimmune diseases. The approval clears the final regulatory step needed to begin enrollment in Australia.
The trial will study CRT-402 in patients with systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and idiopathic inflammatory myopathies (IIM). CREATE said this is its first clinical program in autoimmune disease and the fourth program from its platform to enter the clinic.
Here’s the company’s pipeline:
What is CRT-402?
CRT-402 is a CD19-targeted in vivo CAR-T therapy delivered through the company’s mRNA-LNP platform. It is designed to reprogram a patient’s own T cells directly inside the body to deplete autoreactive B cells.
Unlike conventional CAR-T approaches, CRT-402 does not require ex vivo cell manufacturing. The company says this could support broader access to a B cell depleting approach intended to drive disease into remission.
CREATE also said CRT-402 is designed to support deep B cell depletion and immune reset, with the potential for repeat dosing and off-the-shelf administration. In preclinical studies, the company reported deep and durable B cell depletion in nonhuman primates.
“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.”
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