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(TAA)-Specific Cytotoxic T-Lymphocytes to Pediatric Patients With Lymphomas (pediTACTAL). (pediTACTAL)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05134740
Recruitment Status : Recruiting
First Posted : November 26, 2021
Last Update Posted : July 15, 2022
Sponsor:
Collaborator:
Center for Cell and Gene Therapy, Baylor College of Medicine
Information provided by (Responsible Party):
Lauren Scherer, Baylor College of Medicine

Brief Summary:

Investigators have previously used this sort of therapy to treat Hodgkin or non-Hodgkin lymphoma that is associated with the virus that causes infectious mononucleosis ("mono" or the "kissing disease"), Epstein-Barr virus (EBV). EBV is found in cancer cells of up to half of all patients with Hodgkin's and non-Hodgkin lymphoma. This suggests that it may play a role in causing lymphoma. The cancer cells infected by EBV are able to hide from the body's immune system and escape being killed. Investigators previously tested special white blood cells (cells that help the body fight disease and infection), called T cells. The T cells were trained to kill EBV-infected cells and were tested to see whether treatment with these cells could affect these tumors. In many patients investigators found that giving these trained T cells caused a complete or partial response.

However, many patients do not have EBV found in their lymphoma cells. Therefore, investigators now want to test whether special T lymphocytes directed against other types of proteins that show on the tumor cell surface can result in similar promising results. The proteins that will be targeted 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 stage of the study, investigators will target five TAAs which commonly show on lymphoma cells , called NY-ESO-1, MAGEA4, PRAME, Survivin and SSX. Investigators will do this by using special types of T cells called cytotoxic T lymphocytes (CTLs) generated in the lab. These TM-specific T cells are an investigational product not yet approved by the U.S. Food and Drug Administration.

The purpose of this stage of the study is to find out if TM-specific cytotoxic T cells are safe in children. The investigators want to learn what the side-effects are, and to see whether this therapy might help treat patients who are considered high risk for relapse of Hodgkin disease or non-Hodgkin lymphoma.


Condition or disease Intervention/treatment Phase
Hodgkins Lymphoma Non Hodgkins Lymphoma Biological: TAA-specific CTLs Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Administration of Tumor-Associated Antigen (TAA)-Specific Cytotoxic T-Lymphocytes to Pediatric Patients With Lymphomas (pediTACTAL)
Estimated Study Start Date : September 4, 2022
Estimated Primary Completion Date : February 24, 2025
Estimated Study Completion Date : February 1, 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Experimental Arm
Patients receiving autologous TAA-specific cytotoxic CTLs
Biological: TAA-specific CTLs

Each patient will receive 2 infusions at the same dose, 14 days apart, according to the following dose level:

2 x 10^7/m2





Primary Outcome Measures :
  1. Treatment-related adverse event (tAE) Rate [ Time Frame: 8 weeks post first CTL infusion ]
    Treatment-related adverse event (tAE) rate is the proportion of participants with tAE measured by the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The tAE will be defined as development of Grade III-IV events in any organ system that do not return to grade I within 72 hours with the exception of events that are clearly unrelated, and, of hematological toxicities, which are only considered a tAE if Grade III persisting for up to 10 days or greater than or equal to Grade IV. In addition grade 2 or greater autoimmune reaction will be considered a tAE.


Secondary Outcome Measures :
  1. Obtain information on the expansion, persistence and anti-tumor effects of the adoptively-transferred TAA-specific CTLs [ Time Frame: 8 weeks ]
    Information on the expansion, persistence and anti-tumor effects of the adoptively transferred tumor-specific CTL will be analyzed for the immunological parameters based on multimer analysis, intracellular cytokine staining and ELIspot assays to assess the frequency of cells secreting γ-IFN using the descriptive statistics such as mean, median, standard deviation at each time point. Comparison of diagnostic imaging studies from pre-infusion to 6 weeks following the second infusion will be summarized



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Procurement Inclusion Criteria:

  • Any pediatric patient (age ≥ 1 year and ≤ 21 years), regardless of sex, with a diagnosis of Hodgkin or non-Hodgkin Lymphoma.
  • Patients with life expectancy > 6 weeks.
  • Hgb ≥ 7.0 (transfusions allowed).
  • Informed Consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent. If applicable, patient assents to procurement,

Procurement Exclusion Criteria:

  • Patients with severe intercurrent infection.
  • Patients with active HIV, Hepatitis B, or Hepatitis C infection at time of procurement (can be pending at the time of blood draw).
  • Patients receiving systemic corticosteroids at the time of or within one week prior to procurement.
  • Presence of grade 2-4 acute GVHD or active chronic GVHD > mild global severity score.

Treatment Inclusion Criteria:

  • Any pediatric patient (age ≥ 1 year and ≤ 21 years), regardless of sex, with a diagnosis of Hodgkin or non-Hodgkin Lymphoma who are in complete remission (CR), but at high risk for relapse (specifically, who are stage 3 or stage 4 at diagnosis, are in second complete remission (CR2), and who have previously received >2 lines of lymphoma-directed therapy).
  • Patients with life expectancy > 6 weeks.
  • Pulse oximetry of > 90% on room air in patients who previously received radiation therapy.
  • Patients with a Karnofsky/Lansky score of > 60
  • Patients with bilirubin < 3x upper limit of normal
  • Patients with a creatinine ≤ 2x upper limit of normal for age.
  • Patients with AST < 3x upper limit of normal.
  • Patients with Hgb ≥ 7.0 (transfusions allowed)
  • Acceptable organ function based on clinical or laboratory findings according to investigator discretion
  • Patients should have been off other investigational therapy for one month prior to entry in this study.
  • Patients should have been off conventional therapy including rituximab for at least 1 week prior to entry in this study, and at least 4 weeks since last dose of radiation (if applicable)
  • Informed Consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent. If applicable, patient assents to participation in trial.
  • 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:

  • Patients with severe intercurrent infection.
  • Presence of grade 2-4 acute GVHD or active chronic GVHD > mild global severity score.
  • Patients receiving systemic corticosteroids > 0.5mg/kg prednisone or equivalent.
  • Pregnant or breastfeeding.
  • Active viral infection with HIV or hepatitis type B or C. "Active" infection defined as infectious disease testing indicating that patient blood is reactive for Hep B, C and/or HIV and confirmed using PCR to measure viral load.

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): NCT05134740


Contacts
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Contact: Lauren Scherer, MD 832-824-4829 Lauren.Scherer@bcm.edu
Contact: Wendy Callejas 832-824-1538 wlcalle2@texaschildrens.org

Locations
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United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Lauren Scherer, MD    832-824-4829    Lauren.Scherer@bcm.edu   
Contact: Wendy Callejas    832-824-1538    wlcalle2@texaschildrens.org   
Sponsors and Collaborators
Baylor College of Medicine
Center for Cell and Gene Therapy, Baylor College of Medicine
Investigators
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Principal Investigator: Lauren Scherer, MD Baylor College of Medicine
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Responsible Party: Lauren Scherer, Clinical Instructor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT05134740    
Other Study ID Numbers: H-49884 (pediTACTAL)
First Posted: November 26, 2021    Key Record Dates
Last Update Posted: July 15, 2022
Last Verified: July 2022

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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 Lauren Scherer, Baylor College of Medicine:
Hodgkins Lymphoma
Non Hodgkins Lymphoma
TAA
TAA specific T lymphocytes
Hodgkins Lymphona high risk for relapse
Non-Hodgkin's Lymphoma high risk for relapse
pediatric Hodgkin's Lymphoma high risk
pediatric non-Hodgkin's Lymphoma high risk
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases