Exploratory Study of MSLN-CAR T Cells Secreting PD1/CTLA-4 Nanoantibody for the Treatment of Advanced Solid Tumors

ConditionSolid Tumor
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanghai Cell Therapy Group Co.,Ltd

About this trial

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 and CTLA-4 nanobodies (αPD1/CTLA-4-MSLN-CAR T cells) in patients with solid tumors.

Eligibility criteria

Qualifiers

Patients must have a histological or cytological diagnosis of advanced solid tumors, such as non-small-cell lung cancer and mesothelioma;

Patients must have failed established standard medical anti-cancer therapies;

Greater than or equal to 18 years of age and less than or equal to 70 years of age on day of signing informed consent;

Life expectancy ≥3 months;

Disqualifiers

Prior therapy with targeted therapy or cell therapy against MSLN;

Prior therapy with any gene therapy (including CAR-T cell therapy) or any T cell therapy home and abroad;

Active bacteria, viral or fungal infection, and not contained after anti-infective therapy (positive results in the blood ≤72 hours before infusion);

Patient is positive for Syphilis, Human Immunodeficiency Virus (HIV) , active Hepatitis B (HBsAg reactive) or Hepatitis C (HCV RNA (qualitative) is detected);

Trial design

Treatments tested in this trial

  • αPD1/CTLA4-MSLN-CAR T cells

Treatment groups

16 Participants
are divided into 1 treatment group