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

Solid Tumor Clinical Trial

Official title:

A Phase1/phase2，Single-arm, Open-label Study of RD14-01 in Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05748938
• Other study ID #: BHCT-RD14-01-02
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 8, 2023
• Est. completion date: February 8, 2025

Study information

• Verified date: February 2023
• Source: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
• Contact: Sanbin Wang, Doctor
• Phone: (+86)13187424131
• Email: Sanbin1011[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: February 8, 2025
• Est. primary completion date: August 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Biological:
• RD14-01
ROR1 Targeted CAR-T cells

Locations

Country	Name	City	State
China	920th Hospital of Joint Logistics Support Force of People's Liberation Army of China	Kunming	Yunnan

Sponsors (1)

Lead Sponsor	Collaborator
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DLT and MTD	Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD)	up to 28 days after infusion
Primary	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 after infusion
Secondary	ORR	Overall Response Rate (ORR) by RECIST, version 1.1	up to 28 days after infusion
Secondary	DOR	Duration of response (DOR)	up to 12 months after infusion
Secondary	PFS	Progression Free Survival(PFS)	up to 12 months after infusion
Secondary	OS	Overall Survival (OS)	up to 12 months after infusion
Secondary	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 after infusion
Secondary	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 after infusion