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CAR-pNK Cell Immunotherapy in MUC1 Positive Relapsed or Refractory Solid Tumor

PersonGen BioTherapeutics logo

PersonGen BioTherapeutics

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Colorectal Carcinoma
Triple-Negative Invasive Breast Carcinoma
Gastric Carcinoma
Malignant Glioma of Brain
Non-small Cell Lung Cancer
Hepatocellular Carcinoma
Pancreatic Carcinoma

Treatments

Biological: anti-MUC1 CAR-pNK cells

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02839954
PG-121-001

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of CAR-pNK cell immunotherapy in patients with MUC1 positive relapsed or refractory solid tumor.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 registration.
  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 exclusionary.
  6. The existence of unstable or active ulcers or gastrointestinal bleeding.
  7. Patients with a history of organ transplantation or are waiting for organ transplantation.
  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).

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

CAR-pNK Cell immunotherapy
Experimental group
Description:
Enrolled patients will receive CAR-pNK cell immunotherapy with a novel specific chimeric antigen receptor targeting MUC1 antigen by infusion.
Treatment:
Biological: anti-MUC1 CAR-pNK cells

Trial contacts and locations

1

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Central trial contact

Lin Yang, Ph.D.

Data sourced from clinicaltrials.gov

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