Clinical trial NCT05748938: A Study of RD14-01 in Patients With Advanced Solid Tumors
Official title: A Phase1/phase2，Single-arm, Open-label Study of RD14-01 in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Solid Tumor
Keywords: Solid Tumor
CAR-T Cell
ROR1
Lead sponsor: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: DLT and MTD
timeFrame: up to 28 days after infusion
measure: TEAEs
timeFrame: up to 12 months after infusion
Secondary outcomes:
measure: ORR
timeFrame: up to 28 days after infusion
measure: DOR
timeFrame: up to 12 months after infusion
measure: PFS
timeFrame: up to 12 months after infusion
measure: OS
timeFrame: up to 12 months after infusion
measure: Maximum concentration of RD14-01 (Cmax) in peripheral blood (PB) samples
timeFrame: up to 12 months after infusion
measure: Persistence of RD14-01 CAR T cells in peripheral blood samples
timeFrame: up to 12 months after infusion
Other outcomes:
Locations:
city: Kunming
country: China
facility: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
state: Yunnan
Study officials:
affiliation: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
name: Sanbin Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: