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CAR T-cell Therapy
Engineered 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
Patients positive for hepatitis C virus (HCV) antibody are eligible only if HCV RNA is non-detectable by qPCR.
Confirmation by Tran Laboratory of neoantigen-reactive TCR(s) suitable for TCR-gene therapy.
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. The first part is to see if it's safe, and then they will test if it works.
Who is the study for?
This trial is for adults with advanced epithelial cancers deemed incurable. Participants must have an ECOG performance status of 0-2, meet specific blood and organ function criteria, not be pregnant or breastfeeding, agree to contraception if applicable, and have a life expectancy over 12 weeks. They cannot join if they've had certain recent treatments or surgeries, other active cancers or severe illnesses that could interfere with the study.Check my eligibility
What is being tested?
The trial tests TCR-transduced T cells targeting cancer antigens combined with CD40 activation (CDX-1140) and PD-1 blockade (Pembrolizumab). It's in early stages (Phase I/Ib), focusing on safety and determining the right dose. The design includes initial small groups followed by expansion based on interim results.See study design
What are the potential side effects?
Potential side effects include immune system reactions leading to inflammation in various organs, infusion-related reactions from the cell therapy or drugs used, fatigue due to immune response modulation, as well as increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have hepatitis C but my viral load is undetectable.
Select...
My lab tests show I'm eligible for a specific gene therapy.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I am 18 or older with advanced cancer that cannot be cured.
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
Evaluate the safety, tolerability and DLTs of combinatorial adoptively transferred T-cell receptor gene-engineered T cells (TCR-T) with in vivo CD40 activation and PD-1 blockade, for patients with incurable cancers
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%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
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
Pembrolizumab
2017
Completed Phase 2
~2010
CDX-1140
2017
Completed Phase 1
~140
Find a Location
Who is running the clinical trial?
Providence Health & ServicesLead Sponsor
118 Previous Clinical Trials
822,543 Total Patients Enrolled
Eric Tran, PhDPrincipal InvestigatorProvidence Health & Services
1 Previous Clinical Trials
24 Total Patients Enrolled
Rom Leidner, MDPrincipal InvestigatorProvidence Health & Services
2 Previous Clinical Trials
46 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: CDX-1140 + TCR-T + Pembro
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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