Trials / Unknown
UnknownNCT04503980
αPD1-MSLN-CAR T Cells for the Treatment of MSLN-positive Advanced Solid Tumors
An Exploratory Study of αPD1-MSLN-CAR T Cells Secreting PD-1 Nanobodies for the Treatment of MSLN-positive Advanced Solid Tumors
- Status
- Unknown
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- Shanghai Cell Therapy Group Co.,Ltd · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This is a single arm, open-label, dose escalation clinical study to evaluate the safety and tolerability of autologous mesothelin (MSLN)-targeted chimeric antigen receptor (MSLN-CAR) T cells secreting PD-1 nanobodies (αPD1-MSLN-CAR T cells) in patients with solid tumors.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | αPD1-MSLN-CAR T cells | Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of αPD1-MSLN-CAR T cells. During αPD1-MSLN-CAR T cells production, subjects will receive cyclophosphamide for the purpose of lymphocytes depletion. After lymphodepletion, subjects will receive one dose treatment with αPD1-MSLN-CAR T cells by intravenous (IV) injection. The initial dose of 1×10\^5 CAR+ T cells/kg will be infused on day 0. |
Timeline
- Start date
- 2020-03-26
- Primary completion
- 2021-03-01
- Completion
- 2022-06-01
- First posted
- 2020-08-07
- Last updated
- 2020-08-07
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04503980. Inclusion in this directory is not an endorsement.