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NCT05638828
A Study of RD14-01 in Patients With Advanced Solid Tumors
Conditions: Solid Tumor
Sex: All
Ages: 18 Years – N/A
Phase: EARLY_PHASE1
Enrollment: 24
Sponsor: Shen Lin
Summary
This study will evaluate the safety and tolerability of RD14-01, a ROR1-targeted CAR T-cell therapy, in patients with ROR1+ advanced solid tumors.
Eligibility Criteria
Inclusion Criteria:Age ≥18 years.Patients with histologically or cytologically confirmed advanced solid tumor, who have progressive disease, have undergone systemic therapy for advanced disease, and for whom no standard therapy is available.ROR1+ by central laboratory immunohistochemistry (IHC).Adequate organ and marrow function.At least one measurable lesion as per RECIST v1.1.. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.Ability to understand and provide informed consent.Exclusion Criteria:Prior treatment with any agent targeting ROR1Presence of active central nervous system (CNS) metastasisImpaired cardiac function or clinically significant cardiac diseaseUntreated or active infection at the time of screening or leukapheresisHIV-positive, active acute or chronic HBV or HCV, or active tuberculosisUntreated or active infection at the time of screening or leukapheresisPregnant or breast-feeding females
Source: ClinicalTrials.gov (NCT05638828). StuddyBuddy aggregates publicly available trial information.