A Dose-escalation Phase I Trial of PD-1 Knockout Engineered T Cells for the Treatment of Metastatic Renal Cell Carcinoma
Trial for advanced kidney cancer using engineered T cells is withdrawn.
Plain English Summary
PD-1 Knockout Engineered T Cells for Metastatic Renal Cell Carcinoma. is a Phase 1 clinical trial sponsored by Peking University studying Metastatic Renal Cell Carcinoma. This trial tested a new type of cell therapy called PD-1 Knockout Engineered T Cells for advanced kidney cancer. It was designed for patients with stage IV kidney cancer that had not responded to other treatments. Participation involved receiving the engineered T cells, along with other medications, and regular check-ups. This trial is no longer active, so there are no alternative treatments within this specific study.
Official Summary
This study will evaluate the safety of PD-1 knockout engineered T cells in treating metastatic advanced renal 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 kidney cancer that has spread and has measurable tumors. Individuals whose cancer has progressed after all standard treatments. Patients must have a good performance status (0-1) and a life expectancy of at least 6 months. Prior treatment side effects must have resolved, and major organ functions must be normal. This trial is studying Metastatic Renal Cell Carcinoma, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measured how safe the engineered T cells were and if they caused any serious side effects at different doses. 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 aimed to explore a novel cell therapy approach for a difficult-to-treat cancer, potentially filling a gap for patients with limited options. This research targets Metastatic Renal Cell Carcinoma, where improved treatment options are needed.
Investor Insight
This was an early-phase trial for a rare cancer, indicating a focus on exploring new therapeutic avenues rather than immediate market potential. 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 T cell therapy. Understand that participation involves regular visits for treatment, blood draws, and scans. Be prepared for potential side effects and the need for close monitoring. The trial is being conducted at multiple sites. 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
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 verified stage IV Renal 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
Frequently Asked Questions
What is clinical trial NCT02867332?
NCT02867332 is a Phase 1 INTERVENTIONAL study titled "PD-1 Knockout Engineered T Cells for Metastatic Renal Cell Carcinoma.." It is currently withdrawn and is sponsored by Peking University.
What conditions does NCT02867332 study?
This trial investigates treatments for Metastatic Renal Cell Carcinoma. The primary condition under study is Metastatic Renal Cell Carcinoma.
What treatments are being tested in NCT02867332?
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 Phase 1 mean for NCT02867332?
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 NCT02867332?
This trial is currently "Withdrawn." It started on 2016-11. The estimated completion date is 2020-11.
Who is sponsoring NCT02867332?
NCT02867332 is sponsored by Peking University. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How is NCT02867332 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 NCT02867332?
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 can I find official information about NCT02867332?
The official record for NCT02867332 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT02867332. This government database provides the most up-to-date and detailed information about the trial.
What is NCT02867332 testing in simple terms?
This trial tested a new type of cell therapy called PD-1 Knockout Engineered T Cells for advanced kidney cancer. It was designed for patients with stage IV kidney cancer that had not responded to other treatments.
Why is this trial significant?
This trial aimed to explore a novel cell therapy approach for a difficult-to-treat cancer, potentially filling a gap for patients with limited options.
What are the potential risks of participating in NCT02867332?
Potential side effects include those related to the engineered T cells and other medications used. These could range from flu-like symptoms to more serious immune-related reactions. The trial was withdrawn, so specific risks are no longer applicable to new participants. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT02867332?
Ask your doctor about the specific risks and benefits of T cell therapy. Understand that participation involves regular visits for treatment, blood draws, and scans. Be prepared for potential side effects and the need for close monitoring. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT02867332 signal from an investment perspective?
This was an early-phase trial for a rare cancer, indicating a focus on exploring new therapeutic avenues rather than immediate market potential. 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, along with other medications, and 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.