Clinical trial · Interventional
A Study of RD14-01 in Patients With Advanced Solid Tumors
A Phase1/phase2，Single-arm, Open-label Study of RD14-01 in Patients With Advanced Solid Tumors
NCT05748938CI-TRIAL-00064362unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RD14-01 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RD14-01 treated group
- description
- Subjects who meet the enrollment conditions will receive intravenous infusion of anti--ROR1 CAR-T Cells after lymphodepleting therapy.
- interventionNames
- Biological: RD14-01
Primary outcomes (2)
- measure
- DLT and MTD
- timeFrame
- up to 28 days after infusion
- description
- Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD)
- measure
- TEAEs
- timeFrame
- up to 12 months after infusion
- description
- Adverse events (TEAEs) and incidence after the first infusion, treatment-related adverse events and incidence, adverse events of special concern (AESI) and incidence
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.