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NCT05274451

A Phase 1 Study to Assess the Safety and Efficacy of LYL797, ROR1-Targeting CAR T Cells, in Adults With Relapsed and/or Refractory Solid-Tumor Malignancies

Study Summary

This study will evaluate the safety and tolerability of LYL797, a ROR1-targeted CAR T-cell therapy, in patients with ROR1+ relapsed or refractory triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), platinum-resistant epithelial ovarian cancer/ fallopian tube cancer/ primary peritoneal cancer (Ovarian cancer), or Endometrial cancer. The first part of the study will determine the safe dose for the next part of the study, and will enroll patients with TNBC, NSCLC, Ovarian or Endometrial cancer. The second part of the study will test that dose in additional patients with TNBC, NSCLC, Ovarian or Endometrial cancer.

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Interventions

LYL797BIOLOGICAL
LYL797 is an autologous, genetically (Gen-R™) and epigenetically (Epi-R™) reprogrammed ROR1-targeted chimeric antigen receptor (CAR) T-cell therapy

Study Locations

FacilityCityStateCountry
Mayo ClinicScottsdaleArizonaUnited States
University of California, Los AngelesSanta MonicaCaliforniaUnited States
Yale New Haven HospitalNew HavenConnecticutUnited States
Georgetown UniversityWashington D.C.District of ColumbiaUnited States
Mayo ClinicJacksonvilleFloridaUnited States
University of MiamiMiamiFloridaUnited States
University of ChicagoChicagoIllinoisUnited States
Karmanos Cancer InstituteDetroitMichiganUnited States
Mayo ClinicRochesterMinnesotaUnited States
Memorial Sloan Kettering Cancer CenterNew YorkNew YorkUnited States
Montefiore Medical CenterThe BronxNew YorkUnited States
University of OklahomaOklahoma CityOklahomaUnited States
Oregon Health and Science University HospitalPortlandOregonUnited States
Sidney Kimmel Cancer Center, Jefferson University HospitalPhiladelphiaPennsylvaniaUnited States
Sarah Cannon Research Institute and Tennessee OncologyNashvilleTennesseeUnited States
MD Anderson Cancer CenterHoustonTexasUnited States
Fred Hutchinson Cancer Research CenterSeattleWashingtonUnited States
Froedtert Hospital, Medical College of WisconsinMilwaukeeWisconsinUnited States

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026