An Exploratory Study on the Treatment of Advanced Solid Tumors by Fast CAR T Cells
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 fast autologous mesothelin (MSLN)-targeted chimeric antigen receptor (MSLN-CAR) T cells secreting PD-1 nanobodies in patients with solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with advanced solid tumors through histopathological diagnosis have a positive rate of ≥ 50% for mesothelin expression membrane in tumor tissue samples, PD-L1 positive expression, and sample sources within 2 years；
Late stage malignant solid tumor patients who have failed standard treatment or are intolerant to such treatment and do not have a standard effective treatment plan；
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
Subjects who have undergone other anti-tumor treatments (including radiation therapy, chemotherapy, small molecule, biological or immunotherapy, and other study drugs) other than lymphocytes depletion allowed by the protocol within one month prior to CAR-T infusion;
Prior therapy with any gene therapy (including CAR-T cell therapy) or any T cell therapy home and abroad;
Pregnant or breastfeeding women;
Positive serological reactions for HIV and syphilis; Hepatitis B surface antigen positive, hepatitis B core antibody positive, and hepatitis B virus DNA copy number higher than the detection limit and/or greater than or equal to 1000 copies/mL; Or Hepatitis C virus infected individuals;
Trial design
Design model
Single group
Treatments tested in this trial
Fast CAR T cells
Biological/VaccineSubjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of Fast CAR T cells. During Fast CAR T cells production, subjects will receive cyclophosphamide and fludarabine for the purpose of lymphocytes depletion. After lymphodepletion, subjects will receive one dose treatment with Fast CAR T cells by intravenous (IV) injection.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Fast CAR T cellsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose-limiting toxicity(DLT)
Safety
Time frame
28 daysSecondary outcomes
1
Maximum tolerated dose (MTD)
Tolerability
Time frame
28 days2
Objective response rate (ORR)
Clinical response will be assessed by RECIST 1.1
Time frame
Month 123
Progression-free survival (PFS)
PFS of patients receiving Fast CAR T cells
Time frame
Month 124
Overall survival (OS)
OS of patients receiving Fast CAR T cells
Time frame
Month 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov