A Study of RD14-01 in Patients With Advanced Solid Tumors

Launched by SHEN LIN · Nov 28, 2022

Keywords

ClinConnect Summary

This single-arm, open-label, dose-escalation and dose-expansion study will evaluate the safety and tolerability of RD14-01, ROR1-targeting CAR T cells, in adults with ROR1+ advanced solid tumors. The dose-escalation phase will investigate 3 dose levels to the. The dose-expansion phase will enroll .

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years.
• • 2. 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.
• • 3. ROR1+ by central laboratory immunohistochemistry (IHC).
• • 4. Adequate organ and marrow function.
• • 5. At least one measurable lesion as per RECIST v1.1.
• • 6. . Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• • 7. Ability to understand and provide informed consent.
• Exclusion Criteria:
• • 1. Prior treatment with any agent targeting ROR1
• • 2. Presence of active central nervous system (CNS) metastasis
• • 3. Impaired cardiac function or clinically significant cardiac disease
• • 4. Untreated or active infection at the time of screening or leukapheresis
• • 5. HIV-positive, active acute or chronic HBV or HCV, or active tuberculosis
• • 6. Untreated or active infection at the time of screening or leukapheresis
• • 7. Pregnant or breast-feeding females

Trial Officials