TAA Specific Cytotoxic T Lymphocytes in Patients With Pancreatic Cancer

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Brief Title

TAA Specific Cytotoxic T Lymphocytes in Patients With Pancreatic Cancer

Official Title

Tumor-Associated Antigen (TAA) Specific Cytotoxic T Lymphocytes Administered in Patients With Pancreatic Cancer

Brief Summary

      Patients who have pancreatic cancer that has come back or has not gone away after treatment,
      including the standard treatment for this disease or patients who are not eligible for or
      have elected not to receive standard of care chemotherapy, and patients who will have surgery
      after treatment for pancreatic cancer are eligible for this study. This is a research study
      using special immune system cells called tumor-associated antigen (TAA)-specific cytotoxic T
      lymphocytes, a new experimental therapy.

      The proteins that are targeted in this study are called tumor-associated antigens (TAAs).
      These are cell proteins that are specific to the cancer cell. They do not show, or they show
      up in low quantities, on normal human cells. In this study, five common TAAs will be
      targeted. They are called NY-ESO-1, MAGEA4, PRAME, Survivin and SSX2. On a different study,
      patients have been treated and so far this treatment has shown to be safe.

      Investigators now want to try this treatment in patients with pancreatic cancer.

      These TAA-specific cytotoxic T lymphocytes (TAA-CTLs) are an investigational product not
      approved by the Food and Drug Administration.

      *Arm A and Arm B are closed to new patient enrollment.*
    

Detailed Description

      The patient will give blood to make TAA-Specific cytotoxic T cells in a lab. These cells well
      be grown and frozen. If the TAA-Specific cytotoxic T cells can be made, the time from
      collection of the blood to manufacture of T cells for administration to the patient is about
      1 to 2 months.

      The cells will be infused by intravenous infusion (IV) into the patient over 1-10 minutes.
      The patient may be pre-treated with acetaminophen (Tylenol) and diphenhydramine (Benadryl).
      Acetaminophen (Tylenol) and diphenhydramine (Benadryl) are given to prevent a possible
      allergic reaction to the TAA-CTL administration.

      Patients will be given up to six doses of TAA-CTLs at monthly intervals. The treatments will
      be given by the Center for Cell and Gene Therapy at Houston Methodist Hospital (HMH).

      MEDICAL TESTS BEFORE TREATMENT:

        -  Physical exam.

        -  Blood tests to measure blood cells, kidney and liver function.

        -  Measurements of the patient's tumor by routine imaging studies and/or blood tests. The
           study will use the imaging study that was used before to follow the patient's tumor: CT,
           MRI, or PET.

        -  Blood test to check for pregnancy for female patients who can have children

      MEDICAL TESTS DURING TREATMENT:

      Standard medical tests will be conducted on the day of the second and subsequent infusions:

        -  Physical exams prior to each T cell infusion

        -  Blood tests to measure blood cells, kidney and liver function.

      MEDICAL TESTS AFTER TREATMENT:

      - Measurements the patient's tumor by routine imaging studies and/or blood tests done as per
      standard of care.

      To learn more about the way the TAA-CTLs are working in patient's body, an extra 20-40 mL
      (4-8 teaspoons) of blood will be taken before the infusion, at Weeks 1 and 2 after each
      infusion and at weeks 4, 6 and 8 and months 3, 6, 9 and 12 after the last infusion. The blood
      may be drawn from a central line at the time of the patient's regular blood tests.
      Investigators will use this blood to see how long the TAA-CTLs last, and to look at the
      immune system response to the patient's cancer.

      Study Duration: Patients will be active participants in this study for approximately one year
      after their last dose. Investigators will contact patients once a year for up to 4 additional
      years (total of 5 years follow-up) in order to evaluate disease response long-term.

      *Arm A and Arm B are closed to new patient enrollment.*
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Number of patients with treatment related serious adverse events

Secondary Outcome

 Progression Free Survival using the Kaplan-Meier method

Condition

Pancreatic Cancer

Intervention

multiTAA specific T cells

Study Arms / Comparison Groups

 Group A (Closed to New Patient Enrollment)
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

45

Start Date

January 18, 2018

Completion Date

November 1, 2025

Primary Completion Date

May 1, 2021

Eligibility Criteria

        Inclusion Criteria:

        PROCUREMENT:

          1. Any patient with biopsy proven pancreatic adenocarcinoma.

          2. Patients with life expectancy greater than or equal to 6 months.

          3. Age greater than or equal to 18 years

          4. Hgb greater than or equal to 7.0 g/dl (transfusions allowed)

        TREATMENT:

          1. Any patient with biopsy-proven pancreatic adenocarcinoma:

             Group A: Patients with locally advanced or metastatic adenocarcinoma who are
             responding (defined as stable disease or tumor volume reduction) following 3 cycles of
             first line chemotherapy

             Group B: Patients with locally advanced or metastatic adenocarcinoma who have failed
             first line chemotherapy or are intolerant, ineligible or unwilling to receive standard
             of care chemotherapy

             Group C: Patients with resectable pancreatic cancer who have completed planned
             neo-adjuvant chemotherapy, radiotherapy or combination

          2. Patients must have measurable or evaluable disease per RECIST 1.1 criteria.

          3. Patients with life expectancy greater than or equal to 12 weeks

          4. Age greater than or equal to 18

          5. Pulse oximetry of greater than 95 percent on room air in patients who previously
             received radiation therapy

          6. Patients with an ECOG score of ≤ 2 or Karnofsky score of 50 or greater

          7. Patients with bilirubin less than or equal to 2x upper limit of normal, AST less than
             or equal to 3x upper limit of normal, Hgb greater than or equal to 7.0 g/dl
             (transfusion allowed).

          8. Patients with a creatinine less than or equal to 2x upper limit of normal for age

          9. Patients should have been off other investigational therapy for one month prior to
             receiving treatment on this study.

         10. For Groups B or C patients must be off conventional therapy for at least 1 week prior
             to receiving treatment on this study.

         11. Informed Consent explained to, understood by and signed by patient. Patient given copy
             of informed consent.

         12. Due to unknown effects of this therapy on a fetus, pregnant women are excluded from
             this research. The male partner should use a condom. Females of child-bearing
             potential must be willing to utilize one of the more effective birth control methods
             during the study unless female has had a hysterectomy or tubal ligation.

        Exclusion Criteria:

        PROCUREMENT:

          1. Patients with severe intercurrent infection.

          2. Patients with active HIV infection (can be pending at this time)

        TREATMENT:

          1. Patients with severe intercurrent infection.

          2. Patients receiving systemic corticosteroids (Patients off steroids for at least 48
             hours are eligible)

          3. Pregnant

          4. HIV positive
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Anne Leen, PhD, 713-798-3342, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03192462

Organization ID

H-40378 TACTOPS


Responsible Party

Principal Investigator

Study Sponsor

Baylor College of Medicine

Collaborators

 Center for Cell and Gene Therapy, Baylor College of Medicine

Study Sponsor

Anne Leen, PhD, Principal Investigator, Baylor College of Medicine


Verification Date

December 2019