Solid Tumor
Conditions
Keywords
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. The dose-escalation phase will investigate 3 dose levels to the. The dose-expansion phase will enroll .
Interventions
DRUGRD14-01 Cell injection
RD14-01 Cell injection
Sponsors
Shen Lin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DLT and MTD | up to 28 days | Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) |
| TEAEs | up to 12 months | 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 | Progression Free Survival(PFS) |
| OS | up to 12 months | Overall Survival (OS) |
| ORR | up to 28 days | Overall Response Rate (ORR) by RECIST, version 1.1 |
| Time to Cmax (Tmax) of RD14-01 in peripheral blood (PB) samples | up to 12 months | Time to Cmax (Tmax) of RD14-01 in peripheral blood (PB) samples |
| Persistence of RD14-01 CAR T cells in peripheral blood samples | up to 12 months | 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 | Maximum concentration of RD14-01 (Cmax) in peripheral blood (PB) samples |
| DOR | up to 12 months | Duration of response (DOR) |
Contacts
Primary ContactChangsong Qi, Dr.
Outcome results
None listed