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Trial Title:
A Study of RD14-01 in Patients With Advanced Solid Tumors
NCT ID:
NCT05638828
Condition:
Solid Tumor
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
CAR-T Cell
ROR1
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
RD14-01 Cell injection
Description:
RD14-01 Cell injection
Arm group label:
Cell injection
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 .
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
December 1, 2022
Completion date:
December 1, 2024
Lead sponsor:
Agency:
Shen Lin
Agency class:
Other
Source:
Peking University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05638828
