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

Early Phase 1

Not yet recruiting

• Conditions: Solid Tumor
• Interventions: Drug: RD14-01 Cell injection

• Registration Number: NCT05638828
• Lead Sponsor: Shen Lin

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. The dose-escalation phase will investigate 3 dose levels to the. The dose-expansion phase will enroll .

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-11-28
• Study First Submitted QC: 2022-11-28
• Last Update Submitted: 2022-11-28
• Study Start: 2022-12-01
• Study First Posted: 2022-12-06
• Last Update Posted: 2022-12-06
• Primary Completion: 2023-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cell injection	RD14-01 Cell injection	-

Primary Outcome Measures

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

Secondary Outcome Measures

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