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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 .

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

Conditions
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Solid Tumor

Intervention / Treatment
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* Drug: RD14-01 Cell injection


Participation Criteria
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Eligibility Criteria
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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 ROR1 Presence of active central nervous system (CNS) metastasis Impaired cardiac function or clinically significant cardiac disease Untreated or active infection at the time of screening or leukapheresis HIV-positive, active acute or chronic HBV or HCV, or active tuberculosis Untreated or active infection at the time of screening or leukapheresis Pregnant or breast-feeding females

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cell injection<br> | Drug: RD14-01 Cell injection<br>* RD14-01 Cell injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DLT and MTD | Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) | up to 28 days | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Overall Response Rate (ORR) by RECIST, version 1.1 | up to 28 days | 
| DOR | Duration of response (DOR) | up to 12 months | 
| PFS | Progression Free Survival(PFS) | up to 12 months | 
| OS | Overall Survival (OS) | up to 12 months | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CAR-T Cell, ROR1