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

Solid and Hematological Malignancies Clinical Trial

Official title:

Long Term Follow-up of Subjects Exposed to Genetically Engineered Tumor Antigen Specific T Cell Receptors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03391791
• Other study ID #: ADP-0000-003
• Status: Terminated
• Start date: February 28, 2018
• Est. completion date: July 24, 2018

Study information

• Verified date: June 2018
• Source: Adaptimmune
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 24, 2018
• Est. primary completion date: July 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Solid and Hematological Malignancies

Intervention

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.

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centr	Toronto	Ontario
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	Sarah Cannon Research Institute	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Adaptimmune

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	15 years post last treatment
Secondary	Measurement of Replication Competent Lentivirus (RCL) in genetically modified T cells	Subjects' peripheral blood samples will be used to evaluate RCL	15 years post last treatment
Secondary	Persistence of genetically modified cells in the body	Peripheral blood samples will be used to evaluate persistence	15 years post last treatment
Secondary	Assess the pattern of vector integration sites if at least 1% of cells in the surrogate sample are positive for vector sequences by PCR	Number of samples positive for vector integration by PCR	15 years post last treatment
Secondary	Overall Survival (OS) post-infusion	OS defined as the interval between the date of first T cell infusion and date of death due to any cause	15 years post last treatment