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Long Term Follow up of Subjects Exposed to Genetically Engineered T Cell Receptors

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ClinicalTrials.gov Identifier: NCT03391791
Recruitment Status : Enrolling by invitation
First Posted : January 5, 2018
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
Adaptimmune

Brief Summary:

Subjects who previously took part in an Adaptimmune study and received genetically changed T cells (including but not limited to MAGE-A10ᶜ⁷⁹⁶T and MAGE-A4ᶜ¹º³²T) are asked to take part in this long term follow-up study. Subjects will be asked to join this study once they complete the parent interventional study.

The purpose of this study is to find out if the genetically changed T cells that subjects received in the parent study have any long-term side effects. No additional study drug will be given, but subjects can receive other therapies for their cancer while they are being followed for long term safety in this study.

For a period of 15 years starting from last administration of the genetically changed T cells, subjects will visit their study doctor for a check-up and to have blood tests to look for any changes that might have happened because of the genetically changed T cells.


Condition or disease Intervention/treatment
Solid and Hematological Malignancies Genetic: Genetically engineered T Cell Receptors

Detailed Description:

This is a non-therapeutic, multi-center, long-term follow-up (LTFU) study of subjects who have received lentivirus-mediated genetically engineered T Cell Receptors in an Adaptimmune sponsored clinical trial. The study is designed in accordance with FDA and EMA guidance on gene therapy trials.

The study involves up to 15 years post-infusion monitoring of subjects who have been exposed to lentivirus-mediated gene transfer in Adaptimmune clinical studies. The study will include subjects who have received various T cell receptors including but not limited to MAGE-A10ᶜ⁷⁹⁶T and MAGE-A4ᶜ¹º³²T. Subjects will undergo clinical evaluation (i.e., new medical history, physical exam, adverse events, and exposure to mutagenic agents, anti-cancer therapies and investigational products in other clinical studies) with careful attention to adverse events possibly related to gene transfer or lentivirus-induced diseases. Blood samples will be collected for evaluating persistence of cells with lentiviral vector sequences, the detection of replication competent lentivirus (RCL), and chemistry and hematology laboratory assessments. Subjects will be followed for survival.


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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Long Term Follow-up of Subjects Exposed to Genetically Engineered Tumor Antigen Specific T Cell Receptors
Actual Study Start Date : February 28, 2018
Estimated Primary Completion Date : December 2047
Estimated Study Completion Date : December 2047

Group/Cohort Intervention/treatment
Genetically engineered T Cell Receptor- treated
Long term follow-up of subjects with solid or hematological malignancies who have received lentivirus-mediated genetically engineered T Cell Receptors in a previous trial
Genetic: Genetically engineered T Cell Receptors
No study drug is administered in this study. Subjects who received lentivirus-mediated genetically engineered T Cell Receptors in a previous trial will be evaluated in this trial for long-term safety and efficacy.




Primary Outcome Measures :
  1. Number of subjects with specific Long Term Follow-Up adverse events (AEs), including serious adverse events (SAEs) associated with administration of autologous T cell receptors that have been genetically modified by lentiviral vectors. [ Time Frame: 15 years post last treatment ]
    • New malignancies
    • New incidence or exacerbation of a pre-existing neurologic disorder
    • New incidence or exacerbation of a prior rheumatologic or other autoimmune disorder
    • New incidence of a hematologic disorder
    • Opportunistic and/or serious infections
    • Unanticipated illness and/or hospitalization deemed related to gene modified cell therapy


Secondary Outcome Measures :
  1. Measurement of Replication Competent Lentivirus (RCL) in genetically modified T cells [ Time Frame: 15 years post last treatment ]
    Subjects' peripheral blood samples will be used to evaluate RCL

  2. Persistence of genetically modified cells in the body [ Time Frame: 15 years post last treatment ]
    Peripheral blood samples will be used to evaluate persistence

  3. Assess the pattern of vector integration sites if at least 1% of cells in the surrogate sample are positive for vector sequences by PCR [ Time Frame: 15 years post last treatment ]
    Number of samples positive for vector integration by PCR

  4. Overall Survival (OS) post-infusion [ Time Frame: 15 years post last treatment ]
    OS defined as the interval between the date of first T cell infusion and date of death due to any cause


Biospecimen Retention:   Samples With DNA
Whole blood, serum


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:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with solid or hematological malignancies rolling over from interventional study where they were treated with a genetically modified T-cell receptor
Criteria

Inclusion Criteria:

  • Subjects must have received T cell receptor therapy in an Adaptimmune clinical study
  • Subjects who have provided informed consent prior to their study participation

Exclusion Criteria:

  • Not applicable

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): NCT03391791


Locations
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United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Canada, Ontario
Princess Margaret Cancer Centr
Toronto, Ontario, Canada, M5G1X6
Sponsors and Collaborators
Adaptimmune
Investigators
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Principal Investigator: Marcus Butler, MD Princess Margaret Cancer Centr

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Responsible Party: Adaptimmune
ClinicalTrials.gov Identifier: NCT03391791     History of Changes
Other Study ID Numbers: ADP-0000-003
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018

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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 Adaptimmune:
Cell Therapy
T Cell Therapy
SPEAR T Cell
Immuno-oncology
Metastatic
T Cell Receptor
Long Term Follow Up
Genetically Engineered