Safety and Activity of Programmed Cell Death-1 Knockout Engineered T Cells in Patients With Previously Treated Advanced Esophageal Squamous Cell Carcinoma: An Open-label, Single-arm Phase 1 Study
New T-cell therapy tested for advanced esophageal cancer
Plain English Summary
PD-1 Knockout Engineered T Cells for Advanced Esophageal Cancer is a Not Applicable clinical trial sponsored by Hangzhou Cancer Hospital studying Esophageal Cancer. This trial tests a new type of T-cell therapy designed to fight advanced esophageal cancer. It is for patients with esophageal cancer that has spread and did not respond to previous treatments. Participation involves receiving the engineered T-cells and having regular check-ups. Standard chemotherapy or radiation are current alternatives for this stage of cancer. The trial aims to enroll 16 participants.
Official Summary
This study will evaluate the safety of PD-1 knockout engineered T cells in treating advanced esophageal cancer. Blood or tissue samples will also be collected for research purposes.
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients with esophageal cancer confirmed by biopsy, with disease that can be measured. Must have had cancer spread or return after standard treatments. Must be able to perform daily activities with some assistance (ECOG 0-2) and have at least 3 months to live. Cannot have other cancers within the last 5 years (except certain skin or cervical cancers), active infections, or brain metastases. This trial is studying Esophageal Cancer, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures how many patients respond to the treatment within 1-3 months, indicating if the therapy can shrink or control the cancer. The specific primary outcome measures are: Response Rate (1-3 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial explores a novel T-cell therapy to address the unmet need for effective treatments in patients with advanced esophageal cancer who have exhausted standard options. This research targets Esophageal Cancer, where improved treatment options are needed.
Investor Insight
This early-phase trial investigates a cutting-edge immunotherapy approach, potentially opening new avenues for treating a difficult-to-treat cancer with limited existing options.
Is This Trial Right for Me?
Ask your doctor about the specific risks and benefits of this T-cell therapy compared to other treatments. Understand that you will receive the engineered T-cells and require regular monitoring for side effects and treatment response. Be prepared for potential hospital visits for treatment administration and follow-up appointments. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 16 participants
Interventions
- OTHER: PD-1 Knockout T Cells — Programmed cell death 1(PD-1) gene will be knocked out by CRISPR Cas9
Primary Outcomes
- Response Rate (1-3 months)
Secondary Outcomes
- Incidence of Treatment-Emergent Adverse Events (6 months)
Full Eligibility Criteria
Inclusion Criteria: * Histologically confirmed recurrent or metastatic esophageal cancer * Measurable disease * Progressed after standard treatments * ECOG performance status of 0-2 * Expected life span: \>= 3 months * Toxicities from prior treatment has resolved or ≤ grade 1 * Major organs function normally * Women at pregnant ages should be under contraception * Willing and able to provide informed consent Exclusion Criteria: * Other malignancy within 5 years prior to entry into the study, expect for treated non-melanoma skin cancer and cervical carcinoma in situ * Poor vasculature * Disease to the central nervous system * Blood-borne infectious disease, e.g. hepatitis B * History of mandatory custody because of psychosis or other psychological disease inappropriate for treatment deemed by treating physician * With other immune diseases, or chronic use of immunosuppressants or steroids * Pregnancy (women of childbearing potential:Refusal or inability to use effective means of contraception) * Breastfeeding * Decision of unsuitableness by principal investigator or physician-in-charge
Trial Locations
- Hangzhou Cancer Hospital, Hangzhou, Zhejiang, China
Frequently Asked Questions
What is clinical trial NCT03081715?
NCT03081715 is a Not Applicable INTERVENTIONAL study titled "PD-1 Knockout Engineered T Cells for Advanced Esophageal Cancer." It is currently completed and is sponsored by Hangzhou Cancer Hospital. The trial targets enrollment of 16 participants.
What conditions does NCT03081715 study?
This trial investigates treatments for Esophageal Cancer. The primary condition under study is Esophageal Cancer.
What treatments are being tested in NCT03081715?
The interventions being studied include: PD-1 Knockout T Cells (OTHER). Programmed cell death 1(PD-1) gene will be knocked out by CRISPR Cas9
What does Not Applicable mean for NCT03081715?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT03081715?
This trial is currently "Completed." It started on 2017-03-14. The estimated completion date is 2018-02-28.
Who is sponsoring NCT03081715?
NCT03081715 is sponsored by Hangzhou Cancer Hospital. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT03081715?
The trial aims to enroll 16 participants. The trial status is completed.
How is NCT03081715 designed?
This is a interventional study, uses na allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT03081715?
The primary outcome measures are: Response Rate (1-3 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT03081715 being conducted?
This trial is being conducted at 1 site, including Hangzhou, Zhejiang (China).
Where can I find official information about NCT03081715?
The official record for NCT03081715 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT03081715. This government database provides the most up-to-date and detailed information about the trial.
What is NCT03081715 testing in simple terms?
This trial tests a new type of T-cell therapy designed to fight advanced esophageal cancer. It is for patients with esophageal cancer that has spread and did not respond to previous treatments.
Why is this trial significant?
This trial explores a novel T-cell therapy to address the unmet need for effective treatments in patients with advanced esophageal cancer who have exhausted standard options.
What are the potential risks of participating in NCT03081715?
Common side effects may include fever, fatigue, and reactions at the infusion site. Potential serious risks include cytokine release syndrome, a severe immune reaction, and neurological side effects. The therapy might also affect normal immune function, increasing the risk of infections. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT03081715?
Ask your doctor about the specific risks and benefits of this T-cell therapy compared to other treatments. Understand that you will receive the engineered T-cells and require regular monitoring for side effects and treatment response. Be prepared for potential hospital visits for treatment administration and follow-up appointments. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT03081715 signal from an investment perspective?
This early-phase trial investigates a cutting-edge immunotherapy approach, potentially opening new avenues for treating a difficult-to-treat cancer with limited existing options. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves receiving the engineered T-cells and having regular check-ups. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.