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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 21 days after each t cell infusion
Awards & highlights

Study Summary

This trial is testing a new treatment for pancreatic cancer that has spread to other parts of the body. The treatment is a type of immunotherapy, which uses the patient's own T cells that have been genetically modified to better recognize and target cancer cells. The trial will test what dose of the treatment is safe and effective, as well as how it works with chemotherapy.

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.Check my eligibility
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.See study design
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 below
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I am willing and able to have multiple biopsies of my tumor.
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My kidney function, measured by creatinine or eGFR, is within the normal range.
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My HLA type is HLA-A*02:01.
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It has been over 3 weeks since my last treatment for cancer that has spread.
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I have undergone chemotherapy before.
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My pancreatic cancer has spread and tests show it has mesothelin.
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My pancreatic cancer is confirmed and shows mesothelin expression.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am 18 years old or older.
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I have mild or no shortness of breath and my oxygen levels are above 92% without extra oxygen.
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I have at least two measurable cancer lesions confirmed by recent scans.
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My HLA type is HLA-A*02:01, suitable for the T cell therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 21 days after each t cell infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 21 days after each t cell infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose limiting toxicities
Incidence of adverse events
Secondary outcome measures
Overall response rate
Overall survival
Progression free survival

Side effects data

From 2023 Phase 2 trial • 27 Patients • NCT04002401
88%
Pyrexia
65%
Neutrophil count decreased
62%
Nausea
58%
Hypotension
50%
Anaemia
46%
Headache
38%
Decreased appetite
38%
Fatigue
35%
Confusional state
31%
Hypokalaemia
31%
Diarrhoea
31%
Tachycardia
27%
Constipation
27%
Back pain
27%
Hypophosphataemia
23%
Dizziness
23%
Platelet count decreased
23%
Tremor
23%
B-cell lymphoma
23%
White blood cell count decreased
19%
Oedema peripheral
19%
Neutropenia
19%
Cough
19%
Hypogammaglobulinaemia
19%
Hyponatraemia
19%
Tachypnoea
19%
Agitation
15%
Alanine aminotransferase increased
15%
Thrombocytopenia
15%
Chills
15%
Dyspnoea
15%
Hypomagnesaemia
15%
Sinus tachycardia
15%
Dysphagia
12%
Hypertension
12%
Vomiting
12%
Abdominal pain
12%
Aspartate aminotransferase increased
12%
Pain
12%
Malaise
12%
Myalgia
12%
Hypoxia
12%
Arthralgia
12%
Hyperglycaemia
12%
Covid-19
12%
Peripheral sensory neuropathy
8%
Hyperhidrosis
8%
Aphasia
8%
Pancytopenia
8%
Muscular weakness
8%
Pneumonia
8%
Encephalopathy
8%
Eye pain
8%
Gait disturbance
8%
Oral candidiasis
8%
Urinary tract infection
8%
Sepsis
8%
Blood creatinine increased
8%
Acute myeloid leukaemia
8%
Insomnia
8%
Somnolence
8%
Dysuria
8%
Asthenia
8%
Lymphocyte count decreased
4%
Pleural effusion
4%
Covid-19 pneumonia
4%
Respiratory failure
4%
Febrile neutropenia
4%
Embolism
4%
Depression
4%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Axicabtagene Ciloleucel and Rituximab Combination

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
Bendamustine
2015
Completed Phase 3
~2950
Fludarabine
2012
Completed Phase 3
~1100
Cyclophosphamide
1995
Completed Phase 3
~3770

Find a Location

Who is running the clinical trial?

Lonza Walkersville, Inc.Industry Sponsor
Fred Hutchinson Cancer CenterLead Sponsor
556 Previous Clinical Trials
1,343,380 Total Patients Enrolled
Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,357 Total Patients Enrolled

Media Library

Autologous Mesothelin-specific TCR-T Cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04809766 — Phase 1
Pancreatic Cancer Research Study Groups: Cohorts I, II, and III (FH-TCR Tᴍsʟɴ), Cohort IV (FH-TCR Tᴍsʟɴ) (Discontinued with amendment 3/28/23)
Pancreatic Cancer Clinical Trial 2023: Autologous Mesothelin-specific TCR-T Cells Highlights & Side Effects. Trial Name: NCT04809766 — Phase 1
Autologous Mesothelin-specific TCR-T Cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04809766 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What evidence exists of Cyclophosphamide's efficacy after past clinical trials?

"There are currently 889 clinical trials underway exploring the effectiveness of Cyclophosphamide; of these, 161 are in Phase 3. Philadelphia, Pennsylvania hosts many studies examining this drug but there are 28443 other locations conducting research on it as well."

Answered by AI

What is the traditional application of Cyclophosphamide?

"Cyclophosphamide has been known to successfully treat multiple sclerosis, mixed-cell type lymphoma and myelocytic acute leukemia."

Answered by AI

What is the cumulative amount of participants taking part in this research?

"Affirmative. According to clinicaltrials.gov, the trial's initial launching date was December 14th 2021 and it has been recently updated on July 15th 2022. The research is accepting 15 subjects from a single location."

Answered by AI

Is this study actively recruiting participants?

"Correct. According to clinicaltrials.gov, this scientific endeavour, initially posted on December 14th 2021 is actively seeking participants. 15 volunteers need to be recruited from 1 medical facility for the trial's completion."

Answered by AI

To what extent is Cyclophosphamide an inherent health risk?

"The safety of Cyclophosphamide is assigned a score of 1 since Phase 1 clinical trials provide limited evidence to support efficacy and safety."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Mesothelin-Specific T-Cells (FH-TCR-Tᴍsʟɴ) for the Treatment of Metastatic Pancreatic Ductal Adenocarcinoma
2021. "Mesothelin-Specific T-Cells (FH-TCR-Tᴍsʟɴ) for the Treatment of Metastatic Pancreatic Ductal Adenocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04809766.
~1 spots leftby Jun 2024
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