Solid and Hematological MalignanciesNCT03391791
Long Term Follow up of Subjects Exposed to Genetically Engineered T Cell Receptors
An observational study of Solid and Hematological Malignancies, run by Adaptimmune at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid and Hematological Malignancies
- What is being tested?
- Genetically engineered T Cell Receptors
- How many people
- 2 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 28 Feb 2018to 24 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with solid or hematological malignancies rolling over from interventional study where they were treated with a genetically modified T-cell receptor
Who may be able to join
- Subjects must have received T cell receptor therapy in an Adaptimmune clinical study
- Subjects who have provided informed consent prior to their study participation
Who cannot join
- Not applicable
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
About this study
Official title: Long Term Follow-up of Subjects Exposed to Genetically Engineered Tumor Antigen Specific T Cell Receptors
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.
Read the 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.
- Conditions
- Solid and Hematological Malignancies
- Being tested
- Genetically engineered T Cell Receptors
- Keywords
- Cell Therapy, T Cell Therapy, SPEAR T Cell, Immuno-oncology, Metastatic, T Cell Receptor, Long Term Follow Up, Genetically Engineered
- Medical subject headings
- Hematologic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetically engineered T Cell ReceptorsGenetic
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Genetic: Genetically engineered T Cell Receptors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 years post last treatment
Secondary outcomes (4)
Measurement of Replication Competent Lentivirus (RCL) in genetically modified T cells
Subjects' peripheral blood samples will be used to evaluate RCL
Measured: 15 years post last treatment
Persistence of genetically modified cells in the body
Peripheral blood samples will be used to evaluate persistence
Measured: 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
Number of samples positive for vector integration by PCR
Measured: 15 years post last treatment
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
Measured: 15 years post last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start28 Feb 2018
- Primary completion24 Jul 2018
- Study completion24 Jul 2018
Why it stopped: terminated after participants were enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid and Hematological MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adaptimmune
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marcus Butler, MD, Principal investigator, Princess Margaret Cancer Centr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03391791
- Sponsor's protocol ID
- ADP-0000-003
- Status last verified
- Jun 2018
- First submitted
- 2 Jan 2018
- Last updated
- 7 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow-up of Subjects Exposed to Genetically Engineered Tumor Antigen Specific T Cell Receptors
- ClinicalTrials.gov ID
- NCT03391791
- Acronym / sponsor ID
- ADP-0000-003
- 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
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: terminated after participants were enrolled
- Enrolment
- 2 participants (actual)
- Lead sponsor
- AdaptimmuneIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 24 Jul 2018 (actual)
- Study completion
- 24 Jul 2018 (actual)
- First posted
- 5 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Genetically engineered T Cell Receptor- treated | – | Genetic: Genetically engineered T Cell ReceptorsLong term follow-up of subjects with solid or hematological malignancies who have received lentivirus-mediated genetically engineered T Cell Receptors in a previous trial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with solid or hematological malignancies rolling over from interventional study where they were treated with a genetically modified T-cell receptor
Key inclusion criteria (2 listed)
- Subjects must have received T cell receptor therapy in an Adaptimmune clinical study
- Subjects who have provided informed consent prior to their study participation
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetically engineered T Cell ReceptorsNo 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. | Genetic | Genetically engineered T Cell Receptor- treated |
Primary outcome
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
4 secondary outcomes
Measurement of Replication Competent Lentivirus (RCL) in genetically modified T cells
Time frame: 15 years post last treatment
Persistence of genetically modified cells in the body
Time frame: 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
Time frame: 15 years post last treatment
Overall Survival (OS) post-infusion
Time frame: 15 years post last treatment
Results and safety
The study was stopped early (reason given: terminated after participants were enrolled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus Butler, MD principal investigator
Princess Margaret Cancer Centr
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid and Hematological Malignancies, run by Adaptimmune at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: terminated after participants were enrolled). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 15 years post last treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2021.