Clinical Trial Details
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NCT02839954 : CAR-pNK Cell Immunotherapy in MUC1 Positive Relapsed or Refractory Solid Tumor
PhasePhase 1/Phase 2
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

Male and female subjects with MUC1+ malignancies in patients with no available curative
treatment options who have limited prognosis (several months to < 2 year survival) with
currently available therapies will be enrolled:

1. Eligible diseases: MUC1+ malignant glioma of brain, colorectal carcinoma, gastric
carcinoma, hepatocellular carcinoma, non-small cell lung cancer, pancreatic carcinoma
and triple-negative basal-like breast carcinoma.

2. Patients 18 years of age or older, and must have a life expectancy > 12 weeks.

3. MUC1 is expressed in malignancy tissues by immuno-histochemical (IHC).

4. Eastern cooperative oncology group (ECOG) performance status of 0-2 or karnofsky
performance status (KPS) score is higher than 60.

5. Presence of measurable disease by RECIST.

6. Females of child-bearing potential must have a negative pregnancy test and all
subjects must agree to use an effective method of contraception for up to two weeks
after the last infusion of CAR-pNK cells.

7. 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

8. Ability to give informed consent.

Exclusion Criteria:

1. Patients with symptomatic central nervous system (CNS) involvement.

2. Pregnant or nursing women may not participate.

3. Active HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

4. 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.

5. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not

6. The existence of unstable or active ulcers or gastrointestinal bleeding.

7. Patients with a history of organ transplantation or are waiting for organ

8. Patients need anticoagulant therapy (such as warfarin or heparin).

9. Patients need long-term antiplatelet therapy (aspirin at a dose > 300mg/d; clopidogrel
at a dose > 75mg/d).
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