Clinical trial NCT03391791: Long Term Follow up of Subjects Exposed to Genetically Engineered T Cell Receptors
Official title: Long Term Follow-up of Subjects Exposed to Genetically Engineered Tumor Antigen Specific T Cell Receptors
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Solid and Hematological Malignancies
Keywords: Cell Therapy
T Cell Therapy
SPEAR T Cell
Immuno-oncology
Metastatic
T Cell Receptor
Long Term Follow Up
Genetically Engineered
Lead sponsor: Adaptimmune
Sponsor class: INDUSTRY
First posted: 2018-01-05
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 15 years post last treatment
Secondary outcomes:
measure: Measurement of Replication Competent Lentivirus (RCL) in genetically modified T cells
timeFrame: 15 years post last treatment
measure: Persistence of genetically modified cells in the body
timeFrame: 15 years post last treatment
measure: Assess the pattern of vector integration sites if at least 1% of cells in the surrogate sample are positive for vector sequences by PCR
timeFrame: 15 years post last treatment
measure: Overall Survival (OS) post-infusion
timeFrame: 15 years post last treatment
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centr
state: Ontario
Study officials:
affiliation: Princess Margaret Cancer Centr
name: Marcus Butler, MD
role: PRINCIPAL_INVESTIGATOR
References: