A Study of RD14-01 in Patients With Advanced Solid Tumors
Launched by SHEN LIN · Nov 28, 2022
Trial Information
Current as of January 16, 2025
Unknown status
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
Lin Shen, Prof. Dr.
Principal Investigator
Peking University Cancer Hospital & Institute
About Shen Lin
Shen Lin is a dedicated clinical trial sponsor focused on advancing medical research and development through innovative and efficient trial management. Committed to improving patient outcomes, Shen Lin employs a patient-centric approach, ensuring that clinical studies are designed to meet the highest ethical standards while adhering to regulatory requirements. With a robust portfolio of studies across diverse therapeutic areas, Shen Lin leverages cutting-edge technology and collaborative partnerships to facilitate the timely delivery of new therapies to the market, ultimately enhancing the quality of care in the communities it serves.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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