A Dose-escalation Phase I Trial of PD-1 Knockout Engineered T Cells for the Treatment of Castration Resistant Prostate Cancer
Trial for advanced prostate cancer using engineered T cells withdrawn
Plain English Summary
PD-1 Knockout Engineered T Cells for Castration Resistant Prostate Cancer is a Not Applicable clinical trial sponsored by Peking University studying Hormone Refractory Prostate Cancer. This trial tested a new cell therapy for advanced prostate cancer. It was designed for men with prostate cancer that no longer responds to hormone treatment. Participation involved receiving engineered T cells and other medications, with close monitoring. This type of therapy is experimental, and standard treatments were the alternative.
Official Summary
This study will evaluate the safety of PD-1 knockout engineered T cells in treating castration resistant prostate cancer (CRPC). Blood samples will also be collected for research purposes.
Who Can Participate
Here is what you need to know about eligibility for this trial. Men with prostate cancer that has spread and is resistant to hormone therapy. Patients must have had their cancer progress despite standard treatments. Must be between 18-70 years old with good overall health and organ function. Cannot have certain other medical conditions or be on specific medications. This trial is studying Hormone Refractory Prostate Cancer, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measured how many patients experienced side effects or dose-limiting toxicities, indicating the safety and tolerability of the new T cell therapy. 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 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 aimed to explore a novel cell therapy approach for castration-resistant prostate cancer, addressing a need for new treatment options when standard therapies fail. This research targets Hormone Refractory Prostate Cancer, where improved treatment options are needed.
Investor Insight
This trial explored an innovative immunotherapy for a difficult-to-treat cancer, but its withdrawal suggests early-stage challenges in development or execution.
Is This Trial Right for Me?
Ask your doctor about the specific risks and benefits of this experimental treatment. Understand that participation involves regular clinic visits for infusions, blood draws, and monitoring for side effects. Be prepared for potential side effects and the need for close medical supervision. 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: OBSERVATIONAL
Interventions
- BIOLOGICAL: PD-1 Knockout T Cells — PD-1 Knockout T Cells and PD-1 wild-type T Cells will be made by Cell Biotech Co., Ltd. 2x107/kg T cells will be used for test group and comparable group separately.
- DRUG: Cyclophosphamide — Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion. Interleukin-2 (IL-2) will be given in the following 5 days, 720000 international unit（IU）/Kg/day (if tolerant).
- DRUG: IL-2 — Interleukin-2 (IL-2) will be given in the following 5 days after cell infusion, 720000 international unit（IU）/Kg/ day (if tolerant).
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
- Response Rate:Response will be evaluated according to RECIST v1.1 (90 days)
- Progression free survival - PFS (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to average 10 months)
- Overall Survival - OS (The time from randomization to death from any cause, assessed up to 2 years)
- Peripheral blood circulating tumor DNA (6 weeks)
- Temporal Interleukin-2 change in the peripheral blood (Baseline and 1 month and 3 months)
Full Eligibility Criteria
Inclusion Criteria: * Pathologically and clinical verified castration resistant prostate 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 * 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
- Department of Urology Peking University First Hospital, Beijing, Beijing Municipality, China
Frequently Asked Questions
What is clinical trial NCT02867345?
NCT02867345 is a Not Applicable OBSERVATIONAL study titled "PD-1 Knockout Engineered T Cells for Castration Resistant Prostate Cancer." It is currently withdrawn and is sponsored by Peking University.
What conditions does NCT02867345 study?
This trial investigates treatments for Hormone Refractory Prostate Cancer. The primary condition under study is Hormone Refractory Prostate Cancer.
What treatments are being tested in NCT02867345?
The interventions being studied include: PD-1 Knockout T Cells (BIOLOGICAL), Cyclophosphamide (DRUG), IL-2 (DRUG). PD-1 Knockout T Cells and PD-1 wild-type T Cells will be made by Cell Biotech Co., Ltd. 2x107/kg T cells will be used for test group and comparable group separately.
What does Not Applicable mean for NCT02867345?
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 NCT02867345?
This trial is currently "Withdrawn." It started on 2016-11. The estimated completion date is 2020-12.
Who is sponsoring NCT02867345?
NCT02867345 is sponsored by Peking University. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How is NCT02867345 designed?
This is a observational study.
What are the primary outcomes being measured in NCT02867345?
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 NCT02867345 being conducted?
This trial is being conducted at 1 site, including Beijing, Beijing Municipality (China).
Where can I find official information about NCT02867345?
The official record for NCT02867345 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT02867345. This government database provides the most up-to-date and detailed information about the trial.
What is NCT02867345 testing in simple terms?
This trial tested a new cell therapy for advanced prostate cancer. It was designed for men with prostate cancer that no longer responds to hormone treatment.
Why is this trial significant?
This trial aimed to explore a novel cell therapy approach for castration-resistant prostate cancer, addressing a need for new treatment options when standard therapies fail.
What are the potential risks of participating in NCT02867345?
Potential side effects include reactions to the cell infusion, such as fever or flu-like symptoms. Other risks may involve effects on major organs or the immune system. The treatment involves a complex biological agent, and its long-term effects are still being studied. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT02867345?
Ask your doctor about the specific risks and benefits of this experimental treatment. Understand that participation involves regular clinic visits for infusions, blood draws, and monitoring for side effects. Be prepared for potential side effects and the need for close medical supervision. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT02867345 signal from an investment perspective?
This trial explored an innovative immunotherapy for a difficult-to-treat cancer, but its withdrawal suggests early-stage challenges in development or execution. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involved receiving engineered T cells and other medications, with close monitoring. 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
More Hormone Refractory Prostate Cancer Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.