Your session is about to expire
← Back to Search
Engineered T-cell Therapy for Cancer
Study Summary
This trial is testing a new cancer treatment involving T-cells. The first part is to see if it's safe, and then they will test if it works.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- I had cancer before, but it was treated, hasn't come back in over a year, or was a non-threatening skin cancer or localized cancer that's gone now.I have hepatitis C but my viral load is undetectable.My lab tests show I'm eligible for a specific gene therapy.I have hepatitis B but my viral load is undetectable.I am willing and able to follow the study's requirements.Your platelet count is higher than 100,000 cells per cubic millimeter.I haven't had extensive radiation therapy recently and have recovered from any side effects.I have or had lung inflammation not caused by an infection.I have not received a live vaccine in the last 28 days.I am not pregnant, breastfeeding, planning to become pregnant, or planning to father a child during the study.I do not have serious heart problems or a history of heart attack or stroke in the last year.I have brain metastases that are stable, and any related symptoms are under control without high doses of steroids.I agree to use birth control during and for 6 months after treatment. I am not planning to donate sperm for 3 months after treatment.I stopped a previous cancer treatment due to severe side effects or needed strong medication to manage these side effects.I haven't had cancer treatment within the last 21 days or 5 half-lives, but I may be on hormone therapy for other reasons.I have had cancer spread to the lining of my brain and spinal cord.I haven't taken any experimental cancer treatments or anti-CD40 therapy recently.You are expected to live for at least 12 more weeks.I've had local treatment for comfort care, not within the last week.I may have significant nerve pain or damage.Your alkaline phosphatase level is not more than 2.5 times the upper limit of normal.I take more than 10 mg/day of prednisone or equivalent for an autoimmune disease.I can take care of myself and am up and about more than half of my waking hours.Your neutrophil count is at least 1000 cells per microliter.I am 18 or older with advanced cancer that cannot be cured.I have had an organ or stem cell transplant.Your liver enzyme levels (AST and ALT) must be within a certain range.My hemoglobin level is above 8.0 g/dl, possibly after a transfusion.Your creatinine level is less than or equal to 2.0 mg/dL.I haven't had major surgery in the last 28 days, except for minor procedures to relieve symptoms.I do not have an active tuberculosis infection.I don't have lasting side effects from cancer treatment, except for possible hair loss or skin changes.You have a medical or mental health condition, or abnormal lab results, that could make it risky for you to participate in the trial or make it difficult to interpret the trial's results, according to the investigator's judgment.You have a white blood cell count of at least 2000 cells per microliter.
- Group 1: CDX-1140 + TCR-T + Pembro
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What aims is this trial attempting to fulfill?
"This trial, overseen for a period of about two years, will monitor safety as its primary outcome. Secondary outcomes which are also being monitored include duration of response (time from initial disease response to progression or death), overall survival and clinical benefit rate (percentage with CR, PR or SD lasting at least 4 months)."
Is this investigation still recruiting participants?
"Affirmative. Clinicaltrials.gov records indicate that this medical study is currently engaging in participant recruitment, which began on February 8th 2022 and was recently updated on June 1st 2022. The research endeavour requires 24 subjects from a single site to partake."
To what extent is this clinical trial being utilized by individuals?
"Affirmative. Per the information available on clinicaltrials.gov, this trial is currently accepting applications from prospective participants. It was first posted in February 8th 2022 and most recently updated six weeks ago in June 1st 20202; 24 patients need to be recruited at a single medical centre."
What can be anticipated as potential risks associated with TCR-transduced T cell treatments?
"There is only limited data available regarding the safety and efficacy of TCR-transduced T cells, so it was rated a 1 on our scale."
Share this study with friends
Copy Link
Messenger