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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03706326
Other study ID # 2018-6301
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date September 28, 2018
Est. completion date September 28, 2021

Study information

Verified date October 2018
Source The First Affiliated Hospital of Guangdong Pharmaceutical University
Contact Size Chen, MD, PhD
Phone +8613720956393
Email 13720956393@139.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study is to assess the safety and efficacy of the immunotherapies using anti-MUC1 CAR T cells and /or PD-1 knockout engineered T cells in the treatment of patients with advanced esophageal cancer.


Description:

This is a combined phase 1 and 2 clinical study. The aim of the study is to assess the safety and efficacy of the immunotherapies using anti- MUC1 CAR T cells alone, anti- MUC1 CAR T combining PD-1 knockout engineered T cells, and PD-1 knockout engineered T cell only in the treatment of patients with advanced esophageal cancer. The treatment outcomes from each group will be compared.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date September 28, 2021
Est. primary completion date September 28, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Confirmed diagnosis of advanced esophageal cancer (phase IIIb-IV) according to NCCN clinical practice guidelines in Oncology:Esophageal and Esophagogastric Junction Cancers (2018.V1).

- MUC1 is highly 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, HBV and HCV 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Anti-MUC1 CAR-T cells
Using the T cells from the patients' blood to produce anti-MUC1 CAR-T Cells and then the cells will be infused back to the patients.
PD-1 knockout Engineered T cells
Using the T cells from the blood of the patients to prepare PD-1 knockout T cells, then the cells will be infused back to the patients.
Combination Product:
CAR-T combined with PD-1 Knockout T cells
Using the T cells from the blood of 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

Locations

Country Name City State
China First Affiliated Hospital of Guangdong Pharmaceutical University Guangzhou Guangdong
China Professor Size Chen Guangzhou Guangdong

Sponsors (2)

Lead Sponsor Collaborator
The First Affiliated Hospital of Guangdong Pharmaceutical University Guangzhou Anjie Biomedical Technology Co;LTD

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with adverse events and dose limiting toxicities as assessed by CTCAE v4.0 Safety and tolerability of dose of CART-cells and PD-1 Knockout T cells will be assessed using CTCAE v4.0. approximately 12 months
Secondary Response Rate Will be assessed according to the revised RECIST guideline v1.1 12 months
Secondary Overall Survival - OS Measure the time from enrollment to death Up to 24 months
Secondary Progression free survival - PFS Time from enrollment to date of first documented progression or date of death. Up to 12 months
Secondary Median CAR-T cell persistence Will be measured by quantitative RT-PCR 3 years
See also
  Status Clinical Trial Phase
Recruiting NCT05425472 - A Phase II Study of HR070803 in the Treatment of Advanced Esophageal Cancer Phase 2
Recruiting NCT05174156 - Study on the Biomarker of First-line Immunotherapy Combined With Chemotherapy in Advanced Esophageal Cancer Phase 2
Completed NCT03691090 - Study of SHR-1210 in Combination With Chemotherapy in Advanced Esophageal Cancer Phase 3