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

Overview

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.

Description

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.

Eligibility

Inclusion Criteria:

1. Age ≥18 years old and < 70 years old, gender unlimited;
2. Patients with locally advanced or metastatic solid tumors confirmed by histopathology or cytology;
3. Subjects who failed or were intolerant to standard treatment, or lacked effective treatment;
4. ROR1+ by central laboratory immunohistochemistry (IHC);
5. Adequate organ and marrow function;
6. At least one measurable lesion as per RECIST v1.1;
7. Estimated survival ≥3 months;

        7.Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1; 8.Ability to
        understand and provide informed consent.
        Exclusion Criteria:
          1. Prior treatment with any agent targeting ROR1;
          2. Received anti-tumor therapy within 4 weeks prior to the start of treatment, including
             chemotherapy, radiotherapy, targeted therapy, etc. (excluding preconditioning);
          3. Presence of active central nervous system (CNS) metastasis;
          4. There is or has been a history of severe cardiovascular disease;
          5. There is an uncontrolled pleural, abdominal or pericardial effusion
          6. HIV-positive, active acute or chronic HBV or HCV, or active tuberculosis;
          7. Pregnant or breast-feeding females;
          8. There is a known or suspected failure to comply with the study protocol (for example,
             alcohol abuse, drug dependence, or psychological disorders) or any condition that the
             investigator believes may increase the subjects' risk or interfere with the results of
             the test.