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

Non-small Cell Lung Cancer Clinical Trial

Official title:

Study Evaluating the Efficacy and Safety of Chimeric Antigen Receptor-Modified pNK Cells in MUC1 Positive Advanced Refractory or Relapsed Solid Tumor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02839954
• Other study ID #: PG-121-001
• 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

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma
• Carcinoma, Hepatocellular
• Carcinoma, Non-Small-Cell Lung
• Colorectal Carcinoma
• Colorectal Neoplasms
• Gastric Carcinoma
• Glioma
• Hepatocellular Carcinoma
• Malignant Glioma of Brain
• Non-small Cell Lung Cancer
• Pancreatic Carcinoma
• Pancreatic Neoplasms
• Stomach Neoplasms
• Triple-Negative Invasive Breast Carcinoma

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