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.

Official Title
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A Phase1/phase2，Single-arm, Open-label Study of RD14-01 in Patients With Advanced Solid Tumors

Conditions
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Solid Tumor

Intervention / Treatment
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* Biological: RD14-01


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years old and < 70 years old, gender unlimited; Patients with locally advanced or metastatic solid tumors confirmed by histopathology or cytology; Subjects who failed or were intolerant to standard treatment, or lacked effective treatment; ROR1+ by central laboratory immunohistochemistry (IHC); Adequate organ and marrow function; At least one measurable lesion as per RECIST v1.1; 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: Prior treatment with any agent targeting ROR1; Received anti-tumor therapy within 4 weeks prior to the start of treatment, including chemotherapy, radiotherapy, targeted therapy, etc. (excluding preconditioning); Presence of active central nervous system (CNS) metastasis; There is or has been a history of severe cardiovascular disease; There is an uncontrolled pleural, abdominal or pericardial effusion HIV-positive, active acute or chronic HBV or HCV, or active tuberculosis; Pregnant or breast-feeding females; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: RD14-01 treated group<br>Subjects who meet the enrollment conditions will receive intravenous infusion of anti--ROR1 CAR-T Cells after lymphodepleting therapy. | Biological: RD14-01<br>* ROR1 Targeted CAR-T cells<br>* Other names: CAR-T infusion;|

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 after infusion | 
| 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 after infusion | 

Secondary Outcome Measures

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

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