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

NCT03391791 | Terminated FDA Drug

• 1 other identifier: ADP-0000-003
• Study Type: observational
• Target: 2
• Locations: 2 countries
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (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.

  * 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 Outcomes (4)

• Measurement of Replication Competent Lentivirus (RCL) in genetically modified T cells

  15 years post last treatment

• Persistence of genetically modified cells in the body

  15 years post last treatment

• Assess the pattern of vector integration sites if at least 1% of cells in the surrogate sample are positive for vector sequences by PCR

  15 years post last treatment

• Overall Survival (OS) post-infusion

  15 years post last treatment

Study Arms (1)

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

Interventions

Genetically engineered T Cell Receptors GENETIC

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.

Genetically engineered T Cell Receptor- treated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• Adaptimmune: lead

Study Sites (3)

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Princess Margaret Cancer Centr

Toronto, Ontario, M5G1X6, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum

MeSH Terms

Conditions

Hematologic Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marcus Butler, MD

  Princess Margaret Cancer Centr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: January 5, 2018
• Study Start: February 28, 2018
• Primary Completion: July 24, 2018
• Study Completion: July 24, 2018
• Last Updated: January 7, 2021

Record last verified: 2018-06

Locations

US (2); CA (1)