Capstan Therapeutics Announces Initiation of Phase 1 Trial of Lead In Vivo CAR-T Therapy, CPTX2309, for Treating Autoimmune Disease
SAN DIEGO--(BUSINESS WIRE)--Jun 11, 2025--
Capstan Therapeutics, Inc. ('Capstan'), a clinical-stage biotechnology company dedicated to advancing in vivo reprogramming of cells through RNA delivery using targeted lipid nanoparticles (tLNP), today announced successful dosing of the first participants in its Phase 1 trial of CPTX2309, Capstan's lead anti-CD19 in vivo CAR-T candidate, for the treatment of B cell-mediated autoimmune disorders.
The Phase 1 trial will assess the safety, tolerability, pharmacokinetics, and pharmacodynamic activity (i.e., peripheral B cell depletion and recovery) of CPTX2309 treatment in healthy volunteers at various dose levels. Preclinical studies demonstrated rapid, deep, and transient B cell depletion in blood and tissues, which supported the clinical evaluation of CPTX2309 at the planned dose levels and regimens.
'With CPTX2309, our therapeutic goal is to achieve immune reset through rapid and profound B cell depletion using a transient, tunable, and fully off-the-shelf in vivo CAR-T technology,' said Ramin Farzaneh-Far, M.D., Chief Medical Officer at Capstan. 'The focus on a Phase 1 healthy volunteer population allows us to dose escalate efficiently, and importantly, underscores the potential safety advantages of an approach that does not involve lymphodepletion or permanent CAR integration into the genome. The objective of this trial is to determine a pharmacologically active dose (or doses) that can be advanced into Phase 2 studies to treat patients with autoimmune disease.'
About Capstan Therapeutics, Inc. ( www.capstantx.com )
Capstan is a clinical-stage biotechnology company with a mission to multiply the therapeutic possibilities for patients by developing targeted in vivo RNA technologies. Our proprietary CellSeeker™ tLNP platform technology is composed of novel LNPs conjugated with a recombinant protein binder, such as a monoclonal antibody, that deliver an RNA payload capable of reprogramming cells in vivo. Capstan's initial focus is on developing in vivo CAR-T therapies designed to combine the potency of CAR-T therapy with the convenience of an off-the-shelf product for the treatment of autoimmune diseases. For more information, please visit www.capstantx.com and follow us on LinkedIn.
About CPTX2309
CPTX2309 is an investigational in vivo CAR-T therapy designed to target B cell-mediated autoimmune disorders through tunable and dose-dependent levels of CAR expression with a potentially favorable clinical safety profile. Preclinical data have shown that CPTX2309 demonstrates robust in vivo engineering of CD8+ CAR T cells, profound B cell depletion in blood and tissues, and repopulation with predominantly naïve B cells in non-human primates. Capstan is currently conducting a Phase 1 trial for CPTX2309 in healthy volunteers in Australia.
View source version on businesswire.com:https://www.businesswire.com/news/home/20250611668181/en/
CONTACT: Investors:
Miguel Arcinas
Senior Vice President of Corporate Development
Capstan Therapeutics, Inc.
[email protected]:
Rhiannon Jeselonis
Ten Bridge Communications
[email protected]
KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA
INDUSTRY KEYWORD: RESEARCH GENETICS CLINICAL TRIALS HEALTH TECHNOLOGY BIOTECHNOLOGY HEALTH PHARMACEUTICAL GENERAL HEALTH SCIENCE
SOURCE: Capstan Therapeutics, Inc.
Copyright Business Wire 2025.
PUB: 06/11/2025 07:30 AM/DISC: 06/11/2025 07:28 AM
http://www.businesswire.com/news/home/20250611668181/en
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