Advanced Esophageal CancerPhase 1/2NCT03706326
CAR T and PD-1 Knockout Engineered T Cells for Esophageal Cancer
A Phase 1/2 study testing Anti-MUC1 CAR-T cells, PD-1 knockout Engineered T cells and CAR-T combined with PD-1 Knockout T cells in people with Advanced Esophageal Cancer, run by The First Affiliated Hospital of Guangdong Pharmaceutical University at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Esophageal Cancer
- What is being tested?
- Anti-MUC1 CAR-T cells, PD-1 knockout Engineered T cells and CAR-T combined with PD-1 Knockout T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesChina
- Study dates
- 28 Sep 2018to 28 Sep 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, 510080
Guobiao Huang, 86-20-39352064, 153706227@qq.com
- Recruiting
Professor Size Chen
Guangzhou, Guangdong, 510080
Size Chen, MD,PhD, +8613720956393, 13720956393@139.com
Zhizhou Huang, MSc, +8613268258980, hzhizhou@sina.com
About this study
Official title: Combination Therapy of Anti-MUC1 CAR T Cells and PD-1 Knockout Engineered T Cells for Advanced Esophageal Cancer
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.
Read the detailed 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.
- Conditions
- Advanced Esophageal Cancer
- Being tested
- Anti-MUC1 CAR-T cells, PD-1 knockout Engineered T cells, CAR-T combined with PD-1 Knockout T cells
- Keywords
- Esophageal cancer, Neoplasms, Esophageal, Cancer of Esophagus, Solid tumor
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-MUC1 CAR-T cellsBiological
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 cellsBiological
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.
CAR-T combined with PD-1 Knockout T cellsCombination product
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
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Anti-MUC1 CAR-T cells | Experimental | Anti-MUC1 CAR-T cells will be prepared ex vivo using the T cells from the patients and infused back to the patients. Receives: Biological: Anti-MUC1 CAR-T cells |
| Combination Therapy: CAR-T combining PD-1 knockout T Cells | Experimental | Anti-MUC1 CAR-T cells and PD-1 knockout Engineered T cells will be prepared ex vivo using the T cells from the patients and infused back to the patients. Receives: Combination Product: CAR-T combined with PD-1 Knockout T cells |
| Treatment with PD-1 knockout Engineered T cells | Experimental | PD-1 knockout Engineered T cells will be prepared ex vivo using the T cells from the patients and infused back to the patients. Receives: Biological: PD-1 knockout Engineered T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: approximately 12 months
Secondary outcomes (4)
Response Rate
Will be assessed according to the revised RECIST guideline v1.1
Measured: 12 months
Overall Survival - OS
Measure the time from enrollment to death
Measured: Up to 24 months
Progression free survival - PFS
Time from enrollment to date of first documented progression or date of death.
Measured: Up to 12 months
Median CAR-T cell persistence
Will be measured by quantitative RT-PCR
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start28 Sep 2018
- Primary completion28 Sep 2021 (estimated)
- Study completion28 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Guangdong Pharmaceutical University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Anjie Biomedical Technology Co., Ltd.
- Responsible party
- Principal investigator, Size Chen, The First Affiliated Hospital of Guangdong Pharmaceutical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706326
- Sponsor's protocol ID
- 2018-6301
- Status last verified
- Oct 2018
- First submitted
- 11 Oct 2018
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Therapy of Anti-MUC1 CAR T Cells and PD-1 Knockout Engineered T Cells for Advanced Esophageal Cancer
- ClinicalTrials.gov ID
- NCT03706326
- Acronym / sponsor ID
- 2018-6301
- Conditions
- Advanced Esophageal Cancer
- Keywords
- Esophageal cancer, Neoplasms, Esophageal, Cancer of Esophagus, Solid tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangdong Pharmaceutical UniversityUniversity, hospital or other
- Collaborators
- Guangzhou Anjie Biomedical Technology Co., Ltd.
- Study start
- 28 Sep 2018 (actual)
- Primary completion
- 28 Sep 2021 (estimated)
- Study completion
- 28 Sep 2021 (estimated)
- First posted
- 16 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment with Anti-MUC1 CAR-T cells | Experimental | Biological: Anti-MUC1 CAR-T cellsAnti-MUC1 CAR-T cells will be prepared ex vivo using the T cells from the patients and infused back to the patients. |
| Combination Therapy: CAR-T combining PD-1 knockout T Cells | Experimental | Combination Product: CAR-T combined with PD-1 Knockout T cellsAnti-MUC1 CAR-T cells and PD-1 knockout Engineered T cells will be prepared ex vivo using the T cells from the patients and infused back to the patients. |
| Treatment with PD-1 knockout Engineered T cells | Experimental | Biological: PD-1 knockout Engineered T cellsPD-1 knockout Engineered T cells will be prepared ex vivo using the T cells from the patients and infused back to the patients. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-MUC1 CAR-T cellsUsing 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. | Biological | Treatment with Anti-MUC1 CAR-T cells |
| PD-1 knockout Engineered T cellsUsing 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. | Biological | Treatment with PD-1 knockout Engineered T cells |
| CAR-T combined with PD-1 Knockout T cellsUsing 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 | Combination product | Combination Therapy: CAR-T combining PD-1 knockout T Cells |
Primary outcome
Number of participants with adverse events and dose limiting toxicities as assessed by CTCAE v4.0
Time frame: approximately 12 months
Safety and tolerability of dose of CART-cells and PD-1 Knockout T cells will be assessed using CTCAE v4.0.
4 secondary outcomes
Response Rate
Time frame: 12 months
Overall Survival - OS
Time frame: Up to 24 months
Progression free survival - PFS
Time frame: Up to 12 months
Median CAR-T cell persistence
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Anti-MUC1 CAR-T cells, PD-1 knockout Engineered T cells and CAR-T combined with PD-1 Knockout T cells in people with Advanced Esophageal Cancer, run by The First Affiliated Hospital of Guangdong Pharmaceutical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Size Chen, MD, PhD (+8613720956393, 13720956393@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events and dose limiting toxicities as assessed by CTCAE v4.0 (time frame: approximately 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018.