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TAA-Specific CTLS for Solid Tumors (TACTASOM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02239861
Recruitment Status : Active, not recruiting
First Posted : September 15, 2014
Last Update Posted : January 13, 2020
Sponsor:
Collaborators:
The Methodist Hospital System
Center for Cell and Gene Therapy, Baylor College of Medicine
Solving Kids' Cancer
Pierce Phillips Charity
Information provided by (Responsible Party):
Sarah Whittle, Baylor College of Medicine

Brief Summary:

This is a clinical trial for patients with a solid tumor which has come back, or may come back, or has not gone away after treatment, including the standard treatment we know for these diseases. This is a study using special immune system cells called tumor-associated antigen (TAA)-specific cytotoxic T lymphocytes, a new experimental therapy.

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

The investigators now want to try this treatment in patients with solid tumors.

This protocol is designed as a Phase I dose-escalation study.


Condition or disease Intervention/treatment Phase
Rhabdomyosarcoma Biological: TAA-Specific CTLs Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tumor Associated Antigen (TAA)-Specific Cytotoxic T-Lymphocytes Administered to Patients With Solid Tumors
Actual Study Start Date : April 2015
Actual Primary Completion Date : October 2018
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TAA-Specific CTLs

4 different dosing schedules will be evaluated. 2 to 4 patients will be evaluated on each dosing schedule. The first 2 patients on each dose level will be staggered by 4 weeks (which starts when the first infusion is given, Day 0). No subjects between the ages of 2-18 will be enrolled to a dose level on this protocol, until an adult has been enrolled to and treated on that dose level on one of the protocols being conducted under this same IND. Each patient will receive 2 injections at the same dose,14 days apart: The expected volume of infusion will be 1 to 10 cc.

Dose Level One:

Day 0 and 14: 5 x 10^6 cells/m^2

Dose Level Two:

Day 0 and 14: 1 x 10^7 cells/m^2

Dose Level Three:

Day 0 and 14: 2 x 10^7 cells/m^2

Dose Level Four:

Day 0 and 14: 4 x 10^7 cells/m^2

Biological: TAA-Specific CTLs

Patients may be pre-medicated with Benadryl up to 1 mg/kg IV (max 50 mg) and Tylenol 10 mg/kg po (max 650 mg).

Cell Administration: Tumor-specific T cells will be given by intravenous injection over 1-10 minutes through either a peripheral or a central line.

Patients with stable disease or better will receive up to 6 further doses of CTLs, as long as they continue to show disease stabilization or improvement by RECIST criteria at their 8 week or subsequent evaluations. Each dose will consist of the same number as their second injection or less (if there is not enough product available for the subject's original dose).

Patients will not be able to receive additional doses until the initial safety profile is completed at 6 weeks following the second infusion.

Other Name: Tumor Associated Antigen-Specific Cytotoxic T-Lymphocytes




Primary Outcome Measures :
  1. Number of patients with dose-limiting toxicity. [ Time Frame: 8 weeks ]
    The Phase I dose escalation trial is designed for the primary goal of evaluating the safety and feasibility of administering TAA-CTLs to patients with solid tumors.


Secondary Outcome Measures :
  1. Number of patients with a disease response to the CTLs. [ Time Frame: 8 weeks ]
    The Phase I dose escalation trial is designed for the primary goal of evaluating the safety and feasibility of administering TAA-CTLs to patients with solid tumors.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

THIS PROTOCOL IS CURRENTLY NOT RECRUITING ADULTS.

Procurement Inclusion Criteria:

  1. Any patient regardless of sex with a solid tumor expressing any of the following antigens (PRAME, SSX2, MAGEA4, NY-ESO1-1 and/or Survivin) with:

    1. Active disease after first line therapy;
    2. Refractory disease;
    3. As adjuvant therapy for high risk disease (high risk disease is a disease that has a >50% risk of progression within 5 years)
  2. Patients with life expectancy at least 6 weeks.
  3. Age greater than or equal to 2 and less than or equal to 80 years old.
  4. Hgb >8.0
  5. Informed Consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.

Procurement Exclusion Criteria:

  1. Diagnosis of primary CNS tumor.
  2. Patients with severe intercurrent infection.
  3. Patients with active HIV infection at time of procurement (can be pending at the time of blood draw).
  4. Patients in remission who are enrolled on another study where time to progression or disease-free survival is a primary endpoint.

Treatment Inclusion Criteria:

  1. Any patient regardless of sex with a solid tumor expressing any of the following antigens (PRAME, SSX2, MAGEA4, NY-ESO1-1 and/or Survivin) with:

    1. Active disease after first line therapy;
    2. Refractory disease;
    3. As adjuvant therapy for high risk disease (high risk disease is a disease that has a >50% risk of progression within 5 years)
  2. Patients with life expectancy at least 6 weeks.
  3. Age greater than or equal to 2 and less than or equal to 80 years old.
  4. Pulse oximetry of >95% on room air in patients who previously received radiation therapy.
  5. Patients with a Karnofsky/Lansky score of greater than or equal to 50.
  6. Patients with bilirubin less than or equal to 2x upper limit of normal, AST less than or equal to 3x upper limit of normal, and Hgb >8.0
  7. Patients with a creatinine less than or equal to 2x upper limit of normal for age.
  8. Patients should have been off other investigational therapy for one month prior to entry in this study.
  9. Patients should have been off conventional therapy for at least 1 week prior to entry in this study. PD1/PDL1 inhibitors will be allowed if medically indicated.
  10. Informed Consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
  11. 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.

Treatment Exclusion Criteria:

  1. Diagnosis of primary CNS tumor.
  2. Patients with severe intercurrent infection.
  3. Patients receiving systemic corticosteroids (patients off steroids for at least 48 hours are eligible).
  4. Pregnant or breastfeeding
  5. HIV positive.
  6. Patients in remission who are enrolled on another study where time to progression or disease-free survival is a primary endpoint.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02239861


Locations
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United States, Texas
Houston Methodist Hospital
Houston, Texas, United States, 77030
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
The Methodist Hospital System
Center for Cell and Gene Therapy, Baylor College of Medicine
Solving Kids' Cancer
Pierce Phillips Charity
Investigators
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Principal Investigator: Ann Leen, PhD Baylor College of Medicine
Principal Investigator: Cliona Rooney, PhD Baylor College of Medicine
Principal Investigator: Helen Heslop, MD Baylor College of Medicine
Principal Investigator: Sarah Whittle, MD Baylor College of Medicine
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Responsible Party: Sarah Whittle, Assistant Professor, Pediatric Hematology/Oncology, Center for Cell and Gene Therapy, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02239861    
Other Study ID Numbers: H-35425, TACTASOM
First Posted: September 15, 2014    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sarah Whittle, Baylor College of Medicine:
Rhabdomyosarcoma
cytotoxic T lymphocytes
Additional relevant MeSH terms:
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Rhabdomyosarcoma
Myosarcoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma