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CAR T-cell Therapy
Personalized TCR-T Cell Therapy for Cancer
Phase 1
Waitlist Available
Led By Eric Tran, PhD
Research Sponsored by Providence Health & Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
Patients positive for hepatitis B core antibody (anti-HBc, total), are eligible only if HBV DNA is non-detectable by qPCR.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a new cancer treatment involving T-cells and is designed to see if it is safe. If it is, they will then test its effectiveness.
Who is the study for?
This trial is for adults with advanced epithelial cancers deemed incurable, who have a life expectancy over 12 weeks and specific immune cells suitable for gene therapy. They must not be pregnant or planning pregnancy, agree to contraception, and have adequate organ function. Excluded are those with certain medical conditions, recent malignancies other than treated skin cancer or in situ carcinomas, severe heart disease, active infections like hepatitis B/C unless undetectable by qPCR, HIV-positive patients not on stable treatment, or anyone unable to follow the study protocol.Check my eligibility
What is being tested?
The trial tests TCR-transduced T cells combined with CDX-1140 (a CD40 agonist) and Pembrolizumab (PD-1 blockade) in patients with incurable cancers. It's a phase I/Ib study starting with safety assessments followed by efficacy evaluations using Simon's Two-Stage design to determine if these treatments can safely enhance the body's immune response against cancer.See study design
What are the potential side effects?
Potential side effects include reactions related to the infusion of engineered T-cells such as fever and chills; autoimmune-like symptoms due to increased immune activity; fatigue; possible organ inflammation from CDX-1140; and pembrolizumab may cause immune system-related side effects affecting various organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I have hepatitis B but my viral load is undetectable.
Select...
I have hepatitis C but my viral load is undetectable.
Select...
I am 18 or older with advanced cancer that cannot be cured.
Select...
My lab tests show I'm eligible for a specific gene therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Severity of adverse events
Secondary outcome measures
Clinical benefit rate
Duration of response
Objective response rate
+1 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: CDX-1140 + TCR-T + PembroExperimental Treatment3 Interventions
Patients will receive CDX-1440, TCR-T, and pembrolizumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CDX-1140
2017
Completed Phase 1
~140
Pembrolizumab
FDA approved
Find a Location
Who is running the clinical trial?
Celldex TherapeuticsIndustry Sponsor
60 Previous Clinical Trials
3,806 Total Patients Enrolled
Providence Health & ServicesLead Sponsor
117 Previous Clinical Trials
822,511 Total Patients Enrolled
Eric Tran, PhDPrincipal InvestigatorProvidence Health & Services
1 Previous Clinical Trials
24 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe heart problems or a history of heart attack or stroke in the last year.I don't have lasting side effects from cancer treatment, except for possible hair loss or skin changes.I can take care of myself and am up and about more than half of my waking hours.I do not have an active tuberculosis infection.I have or had lung inflammation not caused by an infection.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.My brain metastases are stable, and any related symptoms are under control without high doses of steroids.You have any medical or mental condition that could increase the risk of participating in the trial or interfere with the interpretation of the results. The doctor will decide if it is safe for you to join the trial.You must have a white blood cell count of at least 2000 cells per microliter.Your alkaline phosphatase level is not more than 2.5 times the upper limit of normal.I agree to use birth control during and for 6 months after treatment. I am not planning to donate sperm for 3 months post-treatment.I haven't had cancer treatment in the last 21 days or 5 half-lives, whichever is longer. Hormone therapy for non-cancer reasons is okay.I may have significant nerve pain or damage, and will discuss this with the study lead.I haven't had extensive radiation therapy recently and have recovered from any side effects.I have hepatitis B but my viral load is undetectable.I have hepatitis C but my viral load is undetectable.I haven't taken any experimental cancer treatments or anti-CD40 therapy recently.I haven't had major surgery in the last 28 days, except for minor procedures to relieve symptoms.I am on high doses of steroids for an autoimmune disease.I have not received a live vaccine in the last 28 days.I am 18 or older with advanced cancer that cannot be cured.Your creatinine level must be less than 2.0 mg/dL.Your platelet count should be at least 100,000 cells per cubic millimeter of blood.Your liver function test results for AST and ALT should not be more than 2.5 times the upper limit of normal (ULN).You are expected to live for at least 12 more weeks.My lab tests show I'm eligible for a specific gene therapy.I am able to follow the study's requirements and attend all follow-up visits.I've had local treatment for comfort care, not within the last week.I had severe side effects from previous immunotherapy that required stopping the treatment or long-term steroids.My hemoglobin level is above 8.0 g/dl, possibly after a transfusion.I have had an organ or stem cell transplant.I have had cancer spread to the lining of my brain and spinal cord.Your body has enough white blood cells called neutrophils, with a count of at least 1000 per microliter.
Research Study Groups:
This trial has the following groups:- Group 1: CDX-1140 + TCR-T + Pembro
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the chief ambitions of this research endeavor?
"This two-year clinical trial will measure the occurrence of adverse events as its primary outcome. Secondary outcomes include duration of response, clinical benefit rate and objective response rate."
Answered by AI
Are there still available slots for participants within this research project?
"The clinicaltrials.gov information suggests that this trial is no longer recruiting participants, as the last time it was edited was September 9th 2022. Despite not actively seeking patients for this study, 2484 other trials are still accepting applications from volunteers at present."
Answered by AI
Has the FDA sanctioned TCR-transduced T cells for therapeutic use?
"Due to the Phase 1 nature of this trial, which indicates a lack of supporting data for both safety and efficacy, our team has assigned TCR-transduced T cells a score of 1."
Answered by AI
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