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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05638828
• Other study ID #: BHCT-RD14-01-03
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: December 1, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: September 2022
• Source: Peking University
• Contact: Changsong Qi, Dr.
• Phone: 13811394004
• Email: xiwangpku[@]126.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. The dose-escalation phase will investigate 3 dose levels to the. The dose-expansion phase will enroll .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• RD14-01 Cell injection
RD14-01 Cell injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shen Lin

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
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
Secondary	ORR	Overall Response Rate (ORR) by RECIST, version 1.1	up to 28 days
Secondary	DOR	Duration of response (DOR)	up to 12 months
Secondary	PFS	Progression Free Survival(PFS)	up to 12 months
Secondary	OS	Overall Survival (OS)	up to 12 months
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
Secondary	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
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