Clinical trial · Interventional
A Study of RD14-01 in Patients With Advanced Solid Tumors
NCT05638828CI-TRIAL-00062505unknownEarly Phase 1ClinicalTrials.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 Cell injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cell injection
- interventionNames
- Drug: RD14-01 Cell injection
Primary outcomes (2)
- measure
- DLT and MTD
- timeFrame
- up to 28 days
- description
- Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD)
- measure
- TEAEs
- timeFrame
- up to 12 months
- description
- Adverse events (TEAEs) and incidence after the first infusion, treatment-related adverse events and incidence, adverse events of special concern (AESI) and incidence.
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.