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

NCT05638828 | Unknown Early Phase 1 DMC

• 1 other identifier: BHCT-RD14-01-03
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Solid Tumor

Keywords

CAR-T Cell; ROR1

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• ORR

  up to 28 days

• DOR

  up to 12 months

• PFS

  up to 12 months

• OS

  up to 12 months

• Maximum concentration of RD14-01 (Cmax) in peripheral blood (PB) samples

  up to 12 months

Study Arms (1)

Cell injection

EXPERIMENTAL

Drug: RD14-01 Cell injection

Interventions

RD14-01 Cell injection DRUG

RD14-01 Cell injection

Cell injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shen Lin: lead

Study Officials

• Lin Shen, Prof. Dr.

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Changsong Qi, Dr.

CONTACT

13811394004; xiwangpku@126.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 6, 2022
• Study Start: December 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: December 6, 2022

Record last verified: 2022-09