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

The 920th Hospital of The Joint Logistics Support Force of the Chinese People's Liberation Army

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Solid Tumor

Treatments: Biological: RD14-01

Study type: Interventional

Funder types: Other

Identifiers

NCT05748938

BHCT-RD14-01-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

RD14-01 treated group

Experimental group

Description:

Subjects who meet the enrollment conditions will receive intravenous infusion of anti--ROR1 CAR-T Cells after lymphodepleting therapy.

Treatment:

Biological: RD14-01