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

NCT ID: NCT05638828

Last Updated: 2022-12-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2024-12-01

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 .

Conditions

Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cell injection

Group Type: EXPERIMENTAL

RD14-01 Cell injection

Intervention Type: DRUG

RD14-01 Cell injection

Interventions

RD14-01 Cell injection

RD14-01 Cell injection

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shen Lin

OTHER

Sponsor Role: lead

Responsible Party

Shen Lin

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lin Shen, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Central Contacts

Changsong Qi, Dr.

Role: CONTACT

xiwangpku@126.com

13811394004

Other Identifiers

BHCT-RD14-01-03

Identifier Type: -

Identifier Source: org_study_id