Trials / Terminated
TerminatedNCT04562298
A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LCAR-M23, a CAR-T Cell Therapy Targeting MSLN in Patients With Relapsed and Refractory Epithelial Ovarian Cancer
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Shanghai East Hospital · Academic / Other
- Sex
- Female
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This study is a prospective, single-arm, open-label, single-dose dose finding and extension study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy profiles of the LCAR-M23 CAR-T cell therapy in subjects with relapsed and refractory epithelial ovarian cancer after prior adequate standard of care.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | LCAR-M23 cells | Prior to infusion of LCAR-M23, subjects will receive a premedication regimen (intravenous infusion of cyclophosphamide 300 mg/m2 and fludarabine 30 mg/m2 once daily for 3 days; fludarabine dose reduction to 25 mg/m2 and cyclophosphamide to 250 mg/m2 are allowed if the subject' s creatinine clearance is 50-70 mL/min/1.73 m2). A single dose, single Infusion of LCAR-M23 is scheduled 5 to 7 days after the initiation of the premedication regimen. |
Timeline
- Start date
- 2020-10-21
- Primary completion
- 2022-06-07
- Completion
- 2022-06-07
- First posted
- 2020-09-24
- Last updated
- 2022-08-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04562298. Inclusion in this directory is not an endorsement.