On October 28, 2025 CREATE Medicines, Inc., formerly Myeloid Therapeutics, Inc. ("CREATE"), reported that Amsterdam University Medical Center ("Amsterdam UMC") has dosed the first patient in the SPaCE-MT clinical trial. The trial will evaluate the treatment of advanced gastroesophageal cancer with CREATE’s MT-302 with capecitabine, oxaliplatin (CAPOX) with or without nivolumab or trastuzumab, representing the first clinical evaluation of an in vivo CAR therapy combined with a standard frontline regimen for solid tumors.

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This trial marks a pivotal step in advancing in vivo immune programming to unlock truly scalable, off-the-shelf cell therapies. With this milestone, CREATE Medicines is one step closer to realizing its vision for the future of in vivo cell therapy through repeat-dose treatments that expand access and integrate seamlessly with existing standards of care.

"In vivo mRNA CARs represent a new class of programmable medicines, and SPaCE–MT brings this modality into frontline care. The early MT–302 data demonstrate safety and activity that support combination therapy – expanding options and meaningfully improving outcomes for patients," said Daniel Getts, Chief Executive Officer of CREATE Medicines.

Professor Hanneke van Laarhoven, leading scientist on the trial and Medical Oncologist and Head of the Department of Medical Oncology at Amsterdam UMC – Cancer Center in the Netherlands, recognizes that MT-302 has significant potential to enhance frontline therapy and improve outcomes for patients with advanced esophageal and gastric cancers. The research team is eager to discover new insights into how this therapy may positively influence outcomes for patients with various types of cancer.

In Vivo CAR Clinical Validation

In vivo CAR therapies have become one of the most closely watched frontiers in oncology, offering the potential to overcome the manufacturing complexity, cost, and scalability limitations of traditional ex vivo CAR-T approaches. CREATE has distinguished itself by generating one of the largest clinical datasets in the in vivo CAR field across multiple Phase 1 studies:

Proof-of-mechanism: Paired biopsies confirmed CAR+ immune cells infiltrating tumors, with immune remodeling and CD8 T-cell recruitment.
Safety data and repeat dosing: Over 200 monotherapy doses administered with a consistent, manageable safety profile and no cumulative toxicities observed to date.
Evidence of activity: CAR expression detected in circulating immune cells, stable disease in several patients, and a confirmed partial response lasting 16 months.
These results provide compelling human validation for CREATE’s mRNA-LNP platform and de-risk next-generation multi-cell programming initiatives.

"The initiation of this study underscores the need for innovative treatment strategies in gastroesophageal cancer, where outcomes still remain very poor," said Matt Maurer, Chief Medical Officer, CREATE Medicines. "By combining our in vivo CAR therapy with established chemotherapeutic and immunotherapy treatments, we aim to unlock the full potential of a coordinated immune attack against cancer."

About SPaCE-MT

SPaCE-MT (Safety and Preliminary Clinical Efficacy of MT-302 with CAPOX-based Regimens in Metastatic Esophagogastric Cancer, EUCT 2024-520213-45-00) is an open-label, Phase 1/2 investigator-initiated trial led by Professor Hanneke van Laarhoven at Amsterdam UMC. The study evaluates the safety, tolerability, and preliminary efficacy of MT-302 in combination with CAPOX with or without nivolumab or trastuzumab in patients with advanced gastroesophageal cancer.

About Gastroesophageal Cancer

With over 1.3 million new cases diagnosed globally each year, gastroesophageal cancers remain a leading cause of cancer-related mortality worldwide. While progress has been made with chemotherapy, targeted agents, and immune checkpoint inhibitors, outcomes for patients with advanced gastroesophageal cancer remain poor, and resistance to frontline therapies is common, underscoring the urgent need for novel treatment approaches.

About MT-302

MT-302 is a first-in-class, TROP2-FcA-LNP therapy that programs immune cells directly in vivo to attack tumors. TROP2 is overexpressed in most epithelial cancers, with limited expression in normal tissues. Unlike antibody-drug conjugates, MT-302 elicits a coordinated immune response by engaging innate and adaptive arms, including presentation of tumor neoantigens to T cells.

(Press release, Amsterdam UMC, OCT 28, 2025, View Source [SID1234657082])