Solid Tumor Clinical Trial
Official title:
A Study of RD14-01 in Patients With Advanced Solid Tumors
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.
Status | Not yet recruiting |
Enrollment | 24 |
Est. completion date | December 1, 2024 |
Est. primary completion date | December 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Shen Lin |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | DLT and MTD | Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) | up to 28 days | |
Primary | TEAEs | Adverse events (TEAEs) and incidence after the first infusion, treatment-related adverse events and incidence, adverse events of special concern (AESI) and incidence. | up to 12 months | |
Secondary | ORR | Overall Response Rate (ORR) by RECIST, version 1.1 | up to 28 days | |
Secondary | DOR | Duration of response (DOR) | up to 12 months | |
Secondary | PFS | Progression Free Survival(PFS) | up to 12 months | |
Secondary | OS | Overall Survival (OS) | up to 12 months | |
Secondary | Maximum concentration of RD14-01 (Cmax) in peripheral blood (PB) samples | Maximum concentration of RD14-01 (Cmax) in peripheral blood (PB) samples | up to 12 months | |
Secondary | Time to Cmax (Tmax) of RD14-01 in peripheral blood (PB) samples | Time to Cmax (Tmax) of RD14-01 in peripheral blood (PB) samples | up to 12 months | |
Secondary | Persistence of RD14-01 CAR T cells in peripheral blood samples | Persistence of RD14-01 CAR T cells in peripheral blood samples | up to 12 months |
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