Blending single-cell biology with generative AI, Cellarity launches its first-in-human trial for CLTY-101—an engineered cell therapy targeting tumor microenvironment reprogramming.
A New Paradigm in Cell Therapy Design
On December 15, 2024, Cellarity Inc. announced the initiation of its first clinical trial for CLTY-101, a novel cell therapy designed using its proprietary AI-driven platform that models cellular behavior at the transcriptomic level. The therapy, aimed at reprogramming the tumor microenvironment (TME) in advanced solid tumors, marks a major milestone for the Flagship-founded biotech.
CLTY-101 is the first candidate to emerge from Cellarity’s “cell behavior modeling” approach, which uses generative AI to simulate how cells respond to perturbations—then designs interventions that shift diseased cells toward healthy states. Unlike traditional CAR-T or TCR therapies, CLTY-101 does not rely on antigen targeting but instead modifies immune cell phenotypes to restore anti-tumor activity.
Dr. Fabrice Chouraqui, CEO of Cellarity, stated:
Series D Fuels Clinical Expansion
The trial launch coincides with the close of a $250 million Series D financing round led by SoftBank Vision Fund 2, with participation from Temasek, Blackstone Life Sciences, and existing investors. The funds will support clinical development of CLTY-101 and advance two additional programs targeting fibrosis and autoimmune disease.
Cellarity’s platform integrates single-cell RNA sequencing, spatial transcriptomics, and AI-based perturbation modeling to identify “cell behavior signatures” that correlate with disease progression. These signatures guide the design of cell therapies that can be manufactured using off-the-shelf donor cells, reducing cost and complexity.
The company plans to open trial sites in Boston, Houston, and Singapore, with initial enrollment targeting patients with refractory pancreatic, ovarian, and colorectal cancers.
Trial Design and Scientific Rationale
The Phase 1 trial (NCT06201457) is a dose-escalation study evaluating safety, tolerability, and preliminary efficacy of CLTY-101 in patients with advanced solid tumors. The therapy consists of allogeneic myeloid cells engineered to express a synthetic transcriptional program that suppresses immunosuppressive signals and enhances T-cell infiltration.
Preclinical data presented at SITC 2024 showed that CLTY-101 reduced tumor burden in murine models of pancreatic cancer by over 70%, with durable immune activation and minimal off-target effects.
Key endpoints include:
Cellarity is also collaborating with the Broad Institute to develop companion diagnostics that track cellular reprogramming in real time.
Implications for Global Oncology and AI-Driven Therapeutics
CLTY-101’s entry into the clinic signals a broader shift toward AI-enabled cell therapy design, moving beyond antigen specificity toward systems-level modulation. If successful, this approach could unlock new treatment paradigms for cancers with low mutational burden or poor immune visibility.
The FDA granted CLTY-101 Fast Track designation in November 2024, citing its novel mechanism and potential to address high-unmet-need indications. Cellarity is also pursuing EMA’s PRIME designation and plans to file for RMAT status in early 2025.
Industry analysts view Cellarity’s trial as a bellwether for AI-native biotech platforms, which raised over $4.3 billion globally in 2024. The company’s approach contrasts with traditional AI drug discovery by focusing on cellular systems rather than molecular targets.
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