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.

Study Overview

• Status: Not yet recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: RD14-01 Cell injection

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 Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Changsong Qi, Dr.; Phone Number: 13811394004; Email: xiwangpku@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cell injection	Drug: RD14-01 Cell injection; RD14-01 Cell injection

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shen Lin
• Investigators: Principal Investigator: Lin Shen, Prof. Dr., Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: November 28, 2022
• First Posted (Estimate): December 6, 2022

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: CAR-T Cell; ROR1
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: BHCT-RD14-01-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No