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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02839954
Other study ID # PG-121-001
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received July 14, 2016
Last updated December 4, 2016
Start date July 2016
Est. completion date July 2018

Study information

Verified date December 2016
Source PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Contact Lin Yang, Ph.D.
Phone 86-512-65922190
Email info@persongen.com
Is FDA regulated No
Health authority China: National Health and Family Planning Commission
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date July 2018
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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).

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Biological:
anti-MUC1 CAR-pNK cells


Locations

Country Name City State
China PersonGen BioTherapeutics (Suzhou) Co., Ltd. Suzhou Jiangsu

Sponsors (3)

Lead Sponsor Collaborator
PersonGen BioTherapeutics (Suzhou) Co., Ltd. Hefei Binhu Hospital, The First People's Hospital of Hefei

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Phase I: Adverse events attributed to the administration of the anti-MUC1 CAR-pNK cells Determine the toxicity profile of the MUC1 targeted CAR-pNK cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0. 2 years Yes
Secondary Phase II: Objective Response Rate The objective response rate (ORR) is defined as the proportion of patients who achieve radiographic partial or complete response (PR or CR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guideline. 2 years No
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