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

Phase 1

Recruiting

• Conditions: Solid Tumor
• Interventions: Biological: RD14-01

• Registration Number: NCT05748938
• Lead Sponsor: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

Brief Summary

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

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.

Study Timeline

• Status Verified: 2023-02
• Study Start: 2023-02-08
• Study First Submitted: 2023-02-15
• Study First Submitted QC: 2023-02-18
• Last Update Submitted: 2023-02-18
• Study First Posted: 2023-03-01
• Last Update Posted: 2023-03-01
• Primary Completion: 2024-08-08
• Study Completion: 2025-02-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RD14-01 treated group	RD14-01	Subjects who meet the enrollment conditions will receive intravenous infusion of anti--ROR1 CAR-T Cells after lymphodepleting therapy.

Primary Outcome Measures

Name	Time	Method
TEAEs	up to 12 months after infusion	Adverse events (TEAEs) and incidence after the first infusion, treatment-related adverse events and incidence, adverse events of special concern (AESI) and incidence
DLT and MTD	up to 28 days after infusion	Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD)

Secondary Outcome Measures

Name	Time	Method
ORR	up to 28 days after infusion	Overall Response Rate (ORR) by RECIST, version 1.1
DOR	up to 12 months after infusion	Duration of response (DOR)
Maximum concentration of RD14-01 (Cmax) in peripheral blood (PB) samples	up to 12 months after infusion	Maximum concentration of RD14-01 (Cmax) in peripheral blood (PB) samples
PFS	up to 12 months after infusion	Progression Free Survival(PFS)
OS	up to 12 months after infusion	Overall Survival (OS)
Persistence of RD14-01 CAR T cells in peripheral blood samples	up to 12 months after infusion	Persistence of RD14-01 CAR T cells in peripheral blood samples

Trial Locations

Locations (1)

920th Hospital of Joint Logistics Support Force of People's Liberation Army of China; 🇨🇳 Kunming, Yunnan, China