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CAR T-cell Therapy
Genetically Modified T-Cells for Pancreatic Cancer
Phase 1
Recruiting
Led By Elena G. Chiorean
Research Sponsored by Fred Hutchinson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Tumor tissue amenable to safe biopsy and subject willing to undergo serial tumor biopsies
Serum creatinine =< 1.5 x upper limit of normal (ULN) or estimated glomerular filtration rate (eGFR) > 60 mL/min
Must not have
Active uncontrolled infection
Prior solid organ transplant or allogeneic hematopoietic stem cell transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 weeks after the last t cell infusion
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new treatment for advanced pancreatic cancer using modified immune cells from the patient. These cells are changed to better recognize and attack cancer cells. The goal is to find the best dose and see if this approach can help patients whose cancer has spread.
Who is the study for?
Adults with metastatic pancreatic ductal adenocarcinoma who've had at least one systemic therapy can join. They must have a life expectancy over 3 months, be willing to undergo tumor biopsies, and not have received recent treatments that could interfere. Participants need properly functioning major organs, no severe autoimmune diseases or organ transplants, and agree to use contraception.
What is being tested?
The trial is testing FH-TCR-Tᴍsʟɴ T-cells designed to target mesothelin on cancer cells combined with chemotherapy drugs like cyclophosphamide and fludarabine. The goal is to find the safest dose that helps these modified T-cells better attack the tumor cells in patients with advanced pancreatic cancer.
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as inflammation in different body parts, symptoms from cell infusion like fever or chills, and typical chemotherapy-related issues such as nausea, fatigue, low blood counts increasing infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am willing and able to have multiple biopsies of my tumor.
Select...
My kidney function, measured by creatinine or eGFR, is within the normal range.
Select...
My HLA type is HLA-A*02:01.
Select...
It has been over 3 weeks since my last treatment for cancer that has spread.
Select...
I have undergone chemotherapy before.
Select...
My pancreatic cancer has spread and tests show it has mesothelin.
Select...
My pancreatic cancer is confirmed and shows mesothelin expression.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I am 18 years old or older.
Select...
I have mild or no shortness of breath and my oxygen levels are above 92% without extra oxygen.
Select...
I have at least two measurable cancer lesions confirmed by recent scans.
Select...
My HLA type is HLA-A*02:01, suitable for the T cell therapy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I currently have an infection that isn't under control.
Select...
I have had a solid organ or bone marrow transplant.
Select...
I am currently being treated for side effects from previous immunotherapy.
Select...
I have brain metastases that have not been treated.
Select...
My genetic test shows I have HLA B*1302.
Select...
I am taking a high dose of steroids daily.
Select...
I need frequent drainage for fluid buildup in my chest or abdomen.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 weeks after the last t cell infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 weeks after the last t cell infusion
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of adverse events
Secondary study objectives
Overall response rate
Overall survival
Progression free survival
Side effects data
From 2023 Phase 2 trial • 27 Patients • NCT0400240188%
Pyrexia
65%
Neutrophil count decreased
62%
Nausea
58%
Hypotension
50%
Anaemia
46%
Headache
38%
Fatigue
38%
Decreased appetite
35%
Confusional state
31%
Tachycardia
31%
Diarrhoea
31%
Hypokalaemia
27%
Constipation
27%
Hypophosphataemia
27%
Back pain
23%
Dizziness
23%
Tremor
23%
B-cell lymphoma
23%
Platelet count decreased
23%
White blood cell count decreased
19%
Cough
19%
Agitation
19%
Hyponatraemia
19%
Neutropenia
19%
Tachypnoea
19%
Hypogammaglobulinaemia
19%
Oedema peripheral
15%
Thrombocytopenia
15%
Dysphagia
15%
Alanine aminotransferase increased
15%
Sinus tachycardia
15%
Chills
15%
Dyspnoea
15%
Hypomagnesaemia
12%
Aspartate aminotransferase increased
12%
Pain
12%
Arthralgia
12%
Myalgia
12%
Vomiting
12%
Hypertension
12%
Abdominal pain
12%
Hyperglycaemia
12%
Hypoxia
12%
Peripheral sensory neuropathy
12%
Covid-19
12%
Malaise
8%
Muscular weakness
8%
Dysuria
8%
Blood creatinine increased
8%
Hyperhidrosis
8%
Insomnia
8%
Encephalopathy
8%
Lymphocyte count decreased
8%
Sepsis
8%
Pancytopenia
8%
Asthenia
8%
Eye pain
8%
Urinary tract infection
8%
Acute myeloid leukaemia
8%
Somnolence
8%
Oral candidiasis
8%
Pneumonia
8%
Gait disturbance
8%
Aphasia
4%
Depression
4%
Syncope
4%
Embolism
4%
Pleural effusion
4%
Respiratory failure
4%
Febrile neutropenia
4%
Covid-19 pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Axicabtagene Ciloleucel and Rituximab Combination
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohorts I, II, and III (FH-TCR Tᴍsʟɴ)Experimental Treatment4 Interventions
LYMPHODEPLETION CHEMOTHERAPY: Patients receive cyclophosphamide IV and fludarabine IV on days -5, -4 and -3 or may optionally receive bendamustine IV on days -4 and -3 prior to the 1st T cell infusion.
T-CELL THERAPY: Patients receive FH-TCR-Tᴍsʟɴ IV over 60-120 minutes on days 0, 21, and 42 in the absence of disease progression or unacceptable toxicity.
Group II: Cohort IV (FH-TCR Tᴍsʟɴ) (Discontinued with amendment 3/28/23)Experimental Treatment3 Interventions
LYMPHODEPLETION CHEMOTHERAPY: Patients receive cyclophosphamide IV and fludarabine IV on days -3 to -1.
T-CELL THERAPY: Patients receive FH-TCR-Tᴍsʟɴ IV over 60-120 minutes on days 0, 21, and 42 in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
2010
Completed Phase 4
~2310
Bendamustine
2015
Completed Phase 3
~3230
Fludarabine
2012
Completed Phase 4
~1860
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for pancreatic cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy drugs like cyclophosphamide and fludarabine work by killing rapidly dividing tumor cells or stopping their growth.
Targeted therapies, such as those inhibiting specific mutations like KRAS G12C, aim to block pathways essential for cancer cell survival. Immunotherapy, including mesothelin-specific T-cells (FH-TCR-Tᴍsʟɴ), involves genetically modifying a patient's T-cells to recognize and kill tumor cells expressing mesothelin, a protein overexpressed in pancreatic cancer.
This approach is significant for pancreatic cancer patients as it offers a personalized treatment option that harnesses the body's immune system to target and eliminate cancer cells, potentially leading to more effective and durable responses.
Find a Location
Who is running the clinical trial?
Lonza Walkersville, Inc.Industry Sponsor
Fred Hutchinson Cancer CenterLead Sponsor
568 Previous Clinical Trials
1,342,060 Total Patients Enrolled
Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
147,985 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had at least one treatment for cancer that has spread.I am willing and able to have multiple biopsies of my tumor.I currently have an infection that isn't under control.I have had a solid organ or bone marrow transplant.My HLA type is HLA-A*02:01.My kidney function, measured by creatinine or eGFR, is within the normal range.I am currently being treated for side effects from previous immunotherapy.It has been over 3 weeks since my last treatment for cancer that has spread.I have undergone chemotherapy before.I am willing to have multiple biopsies if it's safe for me.I have brain metastases that have not been treated.My pancreatic cancer has spread and tests show it has mesothelin.My pancreatic cancer is confirmed and shows mesothelin expression.I am not pregnant and have had a negative pregnancy test in the last 14 days.I am fully active or restricted in physically strenuous activity but can do light work.I am 60 or older and had a heart function test in the last year.I am 18 years old or older.My genetic test shows I have HLA B*1302.I have mild or no shortness of breath and my oxygen levels are above 92% without extra oxygen.I am taking a high dose of steroids daily.I need frequent drainage for fluid buildup in my chest or abdomen.I have at least two measurable cancer lesions confirmed by recent scans.I am 60 or older and had a heart function test showing my heart pumps well.It's been over 3 weeks since my last cancer treatment, except for radiation or bisphosphonates.I have mild or no shortness of breath and my oxygen levels are good without extra oxygen.My HLA type is HLA-A*02:01, suitable for the T cell therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Cohorts I, II, and III (FH-TCR Tᴍsʟɴ)
- Group 2: Cohort IV (FH-TCR Tᴍsʟɴ) (Discontinued with amendment 3/28/23)
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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