Solid Tumor
Conditions
Keywords
Solid Tumor, CAR-T Cell, ROR1
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.
Interventions
BIOLOGICALRD14-01
ROR1 Targeted CAR-T cells
Sponsors
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DLT and MTD | up to 28 days after infusion | Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) |
| TEAEs | up to 12 months after infusion | Adverse events (TEAEs) and incidence after the first infusion, treatment-related adverse events and incidence, adverse events of special concern (AESI) and incidence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | up to 12 months after infusion | Progression Free Survival(PFS) |
| OS | up to 12 months after infusion | Overall Survival (OS) |
| ORR | up to 28 days after infusion | Overall Response Rate (ORR) by RECIST, version 1.1 |
| Persistence of RD14-01 CAR T cells in peripheral blood samples | up to 12 months after infusion | Persistence of RD14-01 CAR T cells in peripheral blood samples |
| Maximum concentration of RD14-01 (Cmax) in peripheral blood (PB) samples | up to 12 months after infusion | Maximum concentration of RD14-01 (Cmax) in peripheral blood (PB) samples |
| DOR | up to 12 months after infusion | Duration of response (DOR) |
Countries
China
Contacts
Primary ContactSanbin Wang, Doctor
Outcome results
None listed