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CAR T-cell Therapy

multiTAA Specific T Cells for Pancreatic Cancer (TACTOPS Trial)

Phase 1 & 2

Waitlist Available

Led By Anne Leen, PhD

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age greater than or equal to 18 years

Any patient with biopsy proven pancreatic adenocarcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

TACTOPS Trial Summary

This trial is for patients with pancreatic cancer who have had surgery and standard treatment. The purpose is to test the safety of a new experimental therapy using immune system cells called TAA-specific cytotoxic T lymphocytes.

Who is the study for?

This trial is for adults over 18 with pancreatic cancer that's persistent after treatment, or those who've chosen not to undergo standard chemotherapy. Candidates must have a life expectancy of at least 6 months, be off other investigational therapies for a month, and not be pregnant. Men must use condoms; women should use effective birth control if they can bear children.Check my eligibility

What is being tested?

The study tests TAA-specific cytotoxic T lymphocytes (TAA-CTLs), an experimental therapy targeting proteins unique to cancer cells in patients with pancreatic cancer. These immune cells are designed to attack five specific tumor-associated antigens (TAAs) that are present on the cancer but not normal cells.See study design

What are the potential side effects?

While the side effects specific to this trial aren't listed, similar therapies often cause flu-like symptoms, fatigue, fever, and potential risk of infection due to immune system activation. The full range of side effects is unknown as this is an investigational product.

TACTOPS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with pancreatic cancer through a biopsy.

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My liver functions and hemoglobin levels are within the required range.

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My kidney function, measured by creatinine, is within twice the normal limit for my age.

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I can care for myself and perform daily activities.

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My oxygen level is above 95% without extra oxygen, after having radiation therapy.

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I am 18 years old or older.

TACTOPS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Patients Who Received 6 Infusions of multiTAA-specific T Cells

Number of Patients With Treatment Related Serious Adverse Events

Secondary outcome measures

Overall Survival Using the Kaplan-Meier Method

Progression Free Survival Using the Kaplan-Meier Method

TACTOPS Trial Design

3Treatment groups

Experimental Treatment

Group I: Group C (Closed to New Patient Enrollment)Experimental Treatment1 Intervention

Patients with resectable pancreatic adenocarcinoma following completion of neoadjuvant chemotherapy, radiotherapy or combination. These patients will receive 6 infusions with a fixed dose of multiTAA specific T cells. One infusion will occur 4 weeks prior to surgical resection (with an option to infuse up to one week earlier) and after the completion of all pre-operative chemotherapy and/or radiation. The subsequent 5 infusions will occur at monthly intervals beginning 8 weeks post-surgery. Following surgery all patients will additionally receive 3 months of standard of care (SOC) chemotherapy starting week 9 after surgery. Hence, SOC chemo will occur weeks 9-11, 13-15, and 17-19 post-surgery and multiTAA T cell infusions will occur at weeks 8, 12, 16, 20, and 24 post-surgery.

Group II: Group B (Closed to New Patient Enrollment)Experimental Treatment1 Intervention

Patients with locally advanced or metastatic pancreatic adenocarcinoma who have failed first line chemotherapy or are intolerant or ineligible to receive standard of care chemotherapy will be evaluated in the clinic and receive 6 infusions (administered at monthly intervals) with a fixed dose of multiTAA specific T cells.

Group III: Group A (Closed to New Patient Enrollment)Experimental Treatment1 Intervention

Patients with locally advanced or metastatic pancreatic adenocarcinoma who are responding following 3 cycles of first line chemotherapy will receive 6 infusions with a fixed dose of multiTAA specific T cells beginning on the 4th week of the 4th cycle of chemotherapy. MultiTAA T cell infusions will occur on day 21 (a chemotherapy "off" week) of each chemotherapy cycle starting on chemotherapy cycle 4.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,001,915 Total Patients Enrolled

Center for Cell and Gene Therapy, Baylor College of MedicineOTHER

111 Previous Clinical Trials

2,780 Total Patients Enrolled

The Methodist Hospital Research InstituteOTHER

271 Previous Clinical Trials

80,338 Total Patients Enrolled

Media Library

multiTAA specific T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03192462 — Phase 1 & 2

Pancreatic Cancer Research Study Groups: Group C (Closed to New Patient Enrollment), Group A (Closed to New Patient Enrollment), Group B (Closed to New Patient Enrollment)

Pancreatic Cancer Clinical Trial 2023: multiTAA specific T cells Highlights & Side Effects. Trial Name: NCT03192462 — Phase 1 & 2

multiTAA specific T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03192462 — Phase 1 & 2

Frequently Asked Questions

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

Are recruitment efforts for the trial still underway?

"Unfortunately, the details on clinicaltrials.gov present that this trial is not actively recruiting at this time; it was initially posted in January 2018 and last modified February 2022. However, there are 699 other trials which currently require patient involvement."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

TAA Specific Cytotoxic T Lymphocytes in Patients With Pancreatic Cancer

Benjamin Leon Musher 2018. "TAA Specific Cytotoxic T Lymphocytes in Patients With Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03192462.