A Phase I Clinical Trial of PD-1 Knockout Engineered T Cells Treating Patients With Advanced Non-small Cell Lung Cancer
Trial tests engineered T cells to fight advanced lung cancer.
Plain English Summary
PD-1 Knockout Engineered T Cells for Metastatic Non-small Cell Lung Cancer is a Phase 1 clinical trial sponsored by Sichuan University studying Metastatic Non-small Cell Lung Cancer. This trial tested a new type of cell therapy called PD-1 knockout engineered T cells. It was for patients with advanced non-small cell lung cancer that had not responded to other treatments. Participation involved receiving the engineered T cells after a procedure to prepare the body. This is an experimental treatment, so standard treatments are the alternative. The trial aims to enroll 12 participants.
Official Summary
This study will evaluate the safety of PD-1 knockout engineered T cells in treating metastatic non-small cell lung cancer. Blood 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 stage IV non-small cell lung cancer that has spread and has measurable tumors. Must have tried all standard treatments and the cancer has progressed. Patients must be in good general health with normal organ function and a life expectancy of at least 6 months. Cannot have certain blood-borne infections, other immune diseases, or require immediate tumor-related emergency treatment. This trial is studying Metastatic Non-small Cell Lung Cancer, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measured how safe the engineered T cells were by tracking any side effects and determining the highest dose patients could tolerate. The specific primary outcome measures are: Number of Participants With Adverse Events and/or Dose Limiting Toxicities as a Measure of Safety and Tolerability of Dose of PD-1 Knockout T Cells Using Common Terminology Criteria for Adverse Events (CTCAE v4.0) in Patients (Dose Escalation - Approximately 6 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 trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.
Why This Trial Matters
This trial explores a novel approach to immunotherapy for lung cancer, aiming to overcome resistance to existing treatments. This research targets Metastatic Non-small Cell Lung Cancer, where improved treatment options are needed.
Investor Insight
This early-phase trial, though completed, signals interest in advanced cell therapies for a large cancer market, with potential for future development if safety and efficacy are proven. Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor about the specific risks and benefits of this experimental therapy. Understand that participation involves blood draws, a procedure to prepare your body, and receiving the engineered T cells. You will need regular follow-up appointments to monitor your health and cancer. 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: NON_RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 12 participants
Interventions
- DRUG: Cyclophosphamide — To deplete Tregs before collecting peripheral blood
- OTHER: PD-1 Knockout T Cells — Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment
Primary Outcomes
- Number of Participants With Adverse Events and/or Dose Limiting Toxicities as a Measure of Safety and Tolerability of Dose of PD-1 Knockout T Cells Using Common Terminology Criteria for Adverse Events (CTCAE v4.0) in Patients (Dose Escalation - Approximately 6 months)
Secondary Outcomes
- Number of Patients With Overall Response (3 months)
- Number of Patients With Disease Control at 8 Weeks (8 weeks)
- Progression Free Survival (PFS) (The time from the date of first edited T cell infusion to the date of disease progression or death due to any reason.)
- Overall Survival (OS) (The duration from date of first edited T cell infusion to the date of death due to any reason)
- Number of Participants With Genes Mutations in Peripheral Blood Circulating Tumor DNA (ctDNA) (Baseline)
Full Eligibility Criteria
Inclusion Criteria: * Pathologically verified stage IV non-small cell lung cancer with measurable lesions (On CT: longest diameter of tumoral lesion \>=10 mm, shorted diameter of lymph node \>=15 mm; measurable lesions should not have been irradiated) * Progressed after all standard treatment * Performance score: 0-1 * Expected life span: \>= 6 months * Toxicities from prior treatment has resolved. Washout period is 4 weeks for chemotherapy, and 2 weeks for targeted therapy * Major organs function normally * Women at pregnant ages should be under contraception * Willing and able to provide informed consent Exclusion Criteria: * Pathology is mixed type * Emergent treatment of tumor emergency is needed * Poor vasculature * Coagulopathy, or ongoing thrombolytics and/or anticoagulation * 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 * Compliance cannot be expected * Other conditions requiring exclusion deemed by physician
Trial Locations
- West China Hospital, Sichuan University, Chengdu, Sichuan, China
Frequently Asked Questions
What is clinical trial NCT02793856?
NCT02793856 is a Phase 1 INTERVENTIONAL study titled "PD-1 Knockout Engineered T Cells for Metastatic Non-small Cell Lung Cancer." It is currently completed and is sponsored by Sichuan University. The trial targets enrollment of 12 participants.
What conditions does NCT02793856 study?
This trial investigates treatments for Metastatic Non-small Cell Lung Cancer. The primary condition under study is Metastatic Non-small Cell Lung Cancer.
What treatments are being tested in NCT02793856?
The interventions being studied include: Cyclophosphamide (DRUG), PD-1 Knockout T Cells (OTHER). To deplete Tregs before collecting peripheral blood
What does Phase 1 mean for NCT02793856?
Phase 1 trials are the first stage of testing a new treatment in humans. They focus on safety, dosage, and side effects, usually involving 20-100 healthy volunteers or patients.
What is the current status of NCT02793856?
This trial is currently "Completed." It started on 2016-08-26. The estimated completion date is 2020-03-17.
Who is sponsoring NCT02793856?
NCT02793856 is sponsored by Sichuan University. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT02793856?
The trial aims to enroll 12 participants. The trial status is completed.
How is NCT02793856 designed?
This is a interventional study, uses non_randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT02793856?
The primary outcome measures are: Number of Participants With Adverse Events and/or Dose Limiting Toxicities as a Measure of Safety and Tolerability of Dose of PD-1 Knockout T Cells Using Common Terminology Criteria for Adverse Events (CTCAE v4.0) in Patients (Dose Escalation - Approximately 6 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT02793856 being conducted?
This trial is being conducted at 1 site, including Chengdu, Sichuan (China).
Where can I find official information about NCT02793856?
The official record for NCT02793856 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT02793856. This government database provides the most up-to-date and detailed information about the trial.
What is NCT02793856 testing in simple terms?
This trial tested a new type of cell therapy called PD-1 knockout engineered T cells. It was for patients with advanced non-small cell lung cancer that had not responded to other treatments.
Why is this trial significant?
This trial explores a novel approach to immunotherapy for lung cancer, aiming to overcome resistance to existing treatments.
What are the potential risks of participating in NCT02793856?
The main risks are side effects from the treatment, which can range from mild to severe. Potential side effects include reactions to the T cell infusion and effects on normal organs. The engineered T cells could potentially attack healthy tissues. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT02793856?
Ask your doctor about the specific risks and benefits of this experimental therapy. Understand that participation involves blood draws, a procedure to prepare your body, and receiving the engineered T cells. You will need regular follow-up appointments to monitor your health and cancer. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT02793856 signal from an investment perspective?
This early-phase trial, though completed, signals interest in advanced cell therapies for a large cancer market, with potential for future development if safety and efficacy are proven. This is a Phase 1 trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involved receiving the engineered T cells after a procedure to prepare the body. 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.
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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.