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Trial Title:
A Study of RD14-01 in Patients With Advanced Solid Tumors
NCT ID:
NCT05748938
Condition:
Solid Tumor
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Solid Tumor
CAR-T Cell
ROR1
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
RD14-01
Description:
ROR1 Targeted CAR-T cells
Arm group label:
RD14-01 treated group
Other name:
CAR-T infusion
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Address:
City:
Kunming
Zip:
650000
Country:
China
Status:
Recruiting
Contact:
Last name:
Sanbin Wang, Doctor
Phone:
(+86)13187424131
Email:
Sanbin1011@163.com
Start date:
February 8, 2023
Completion date:
February 8, 2025
Lead sponsor:
Agency:
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Agency class:
Other
Source:
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05748938
