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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RD14-01 treated group | Experimental | Subjects who meet the enrollment conditions will receive intravenous infusion of anti--ROR1 CAR-T Cells after lymphodepleting therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RD14-01 | Biological | ROR1 Targeted CAR-T cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| DLT and MTD | Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) | up to 28 days after infusion |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Overall Response Rate (ORR) by RECIST, version 1.1 | up to 28 days after infusion |
| DOR | Duration of response (DOR) | up to 12 months after infusion |
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Inclusion Criteria:
7.Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1; 8.Ability to understand and provide informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sanbin Wang, Doctor | Contact | (+86)13187424131 | Sanbin1011@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Sanbin Wang, Doctor | 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China | Recruiting | Kunming | Yunnan | 650000 | China |
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| ID | Term |
|---|---|
| D016219 | Immunotherapy, Adoptive |
| ID | Term |
|---|---|
| D019264 | Adoptive Transfer |
| D007116 | Immunization, Passive |
| D007114 | Immunization |
| D007167 | Immunotherapy |
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| PFS | Progression Free Survival(PFS) | up to 12 months after infusion |
| OS | Overall Survival (OS) | up to 12 months after infusion |
| 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 |
| 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 |
| D056747 |
| Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |