Trial | NCT03525782  Report issue

Title

Anti-MUC1 CAR T Cells and PD-1 Knockout Engineered T Cells for NSCLC
A Clinical Study of Anti-MUC1 CAR T Cells and PD-1 Knockout Engineered T Cells for Patients With Advanced Non-small Cell Lung Cancer

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    60
The study is to assess the safety and efficacy of the anti-MUC1 CAR T cells and /or PD-1 knockout engineered T cells for patients with advanced non-small cell lung cancer.
This is a combined phase 1 and 2 clinical study. The study is to assess the safety and efficacy of the anti-MUC1 CAR T cells and /or PD-1 knockout engineered T cells for patients with advanced non-small cell lung cancer. The treatment outcomes will be compared.
Study Started
Feb 01
2018
Primary Completion
Jan 31
2021
Anticipated
Study Completion
Jan 31
2022
Anticipated
Last Update
May 16
2018

Biological CAR-T Cells

Using the T cells from the patients to produce anti-MUC1 CAR-T Cells and then the cells will be infused back to the patients.

Combination Product CAR-T combining PD-1 Knockout

Using the T cells from the patients to prepare anti-MUC1 CAR-T Cells and PD-1 knockout T cells, then the cells will be infused back to the patients

Biological PD-1 knockout

Using the T cells from the patients to prepare PD-1 knockout T cells, then the cells will be infused back to the patients

Drug PD-1 mAb

Patients will be treated with an identical course with a FDA approved monoclonal antibody against PD-1

  • Other names: Keytruda

Other Sham control

Patient's T cell will treated ex vivo with modification and then infused back in a similar time course.

CAR-T Experimental

Anti-MUC1 CAR-T cells will be prepared ex vivo and infused back to the patients.

CAR-T combining PD-1 knockout Experimental

Anti-MUC1 CAR-T cells and PD-1 knockout Engineered T cells will be prepared ex vivo and infused back to the patients.

PD-1 knockout Experimental

PD-1 knockout Engineered T cells will be prepared ex vivo and infused back to the patients.

PD-1 mAb Active Comparator

Patients will be treated with a FDA approved monoclonal antibody for an identical course of treatment. This group will serve as PD-1 antibody treated group.

Sham Control Placebo Comparator

Patient's T cells will be separate without genetic or engineered modification ex vivo and infused back to the patients.

Criteria 

Inclusion Criteria:

MUC1 is expressed in malignancy tissues by immuno-histochemical (IHC).
Eastern cooperative oncology group (ECOG) performance status of 0-1 or karnofsky performance status (KPS) score is higher than 60.
Patients have a life expectancy > 12 weeks.
Adequate venous access for apheresis or venous sampling, and no other contraindications for leukapheresis.
Negative pregnancy test for females of child-bearing potentials.
Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: White blood cell count (WBC) ≥ 2500c/ml, Platelets ≥ 50×10^9/L, Hb ≥ 9.0g/dL, lymphocyte (LY) ≥ 0.7×10^9/L, LY% ≥ 15%, Alb ≥ 2.8g/dL, serum lipase and amylase < 1.5×upper limit of normal, serum creatinine ≤ 2.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal, serum total bilirubin ≤ 2.0mg/dL. These tests must be conducted within 7 days prior to registration.
Signed informed consent form.

Exclusion Criteria:

Number of T cells is less than 10% or the amplification of the T cells via artificial antigen presenting cell (aAPC) stimulation is less than 5 times.
Patients with symptomatic central nervous system (CNS) involvement.
Pregnant or nursing women.
Known HIV infection.
Serious illness or medical condition which would not permit the patient to be managed according to the protocol, including active uncontrolled infection, major cardiovascular, coagulation disorders, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive/restrictive pulmonary disease, or psychiatric or emotional disorders.
History of severe immediate hypersensitivity to any of the agents including cyclophosphamide, fludarabine, or aldesleukin.
Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
Previously treatment with any gene therapy products.
The existence of unstable or active ulcers or gastrointestinal bleeding. Patients with portal vein vascular invasion or extrahepatic, are excluded from this study.
Patients with a history of organ transplantation or are waiting for organ transplantation.
No Results Posted