Trials / Unknown
UnknownNCT06256055
Phase 1 Study of UCMYM802 Injection in Mesothelin-positive Advanced Malignant Solid Tumors
A First-In-Human, Single Arm, Open-label, Phase 1 Dose-Escalation Study of UCMYM802 Injection in Mesothelin-positive Advanced Malignant Solid Tumors
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- Sponsor
- UTC Therapeutics Inc. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This is a first-in-human, single-arm, open-label, dose escalation clinical study to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics, immunogenicity and preliminary efficacy of UCMYM802 (Circular mRNA encoding Anti-Mesothelin CAR-T) injection in patients with Mesothelin-positive advanced malignant solid tumors.
Detailed description
All subjects who qualified after screening will receive the proposed dose of UCMYM802 injection once a week, 4 times in total. The Starting Dose of cell injection was set at 1×10\^8, and the maximum dose was set at 2.0×10\^9.
Conditions
- Malignant Mesothelioma
- Colorectal Cancer
- Bile Duct Cancer
- Rectal Cancer
- Ovary Cancer
- Pancreatic Cancer
- Breast Cancer Female
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | UCMYM802 Injection | 1×10\^8\~2×10\^9 cells will be infused intravenously for 4 times. |
Timeline
- Start date
- 2024-03-05
- Primary completion
- 2025-03-01
- Completion
- 2025-04-01
- First posted
- 2024-02-13
- Last updated
- 2024-07-24
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06256055. Inclusion in this directory is not an endorsement.