Non-Small Cell Lung CancerPhase 1NCT02592577
MAGE A10ᶜ⁷⁹⁶T for Advanced NSCLC
A Phase 1 study testing Autologous Genetically modified T cells, MAGEA10ᶜ⁷⁹⁶T in people with Non-Small Cell Lung Cancer and Carcinoma, run by Adaptimmune at 19 sites in 4 countries.
Trial summary
This first time in human study is intended for men and women at least 18 years of age who have advanced lung cancer which has grown or returned after being treated. In particular, it is a study for subjects who have a blood test positive for HLA-A*02:01 and/or HLA-A*02:06 and a tumor test positive for MAGE A10 protein… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Carcinoma
- What is being tested?
- Autologous Genetically modified T cells, MAGEA10ᶜ⁷⁹⁶T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 19 sitesin 4 countries
- Study dates
- Nov 2015to 17 Mar 2021
- Phase
- Phase 1
- 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
Who may be able to join
- Subject has histologically or cytologically confirmed diagnosis of advanced non-small cell lung cancer (stage IIIB or IV) or recurrent disease
- Subject has received at least one line of prior therapy
- Subjects with known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase receptor (ALK) or ROS1 gene rearrangements must have failed (progressive disease or unacceptable toxicity) at least one prior EGFR or ALK or ROS1 tyrosine kinase inhibitor, respectively. Subject may have received PD-1 or PDL-1 inhibitors and or chemotherapy. There is no limit on lines of prior anti-cancer therapy (a washout period applies for recent anti-cancer treatments).
- Subject has measurable disease according to RECIST v1.1 criteria prior to lymphodepletion.
- Subject is HLA-A*02:01 or HLA-A*02:06 positive.
- Subject's tumor (either an archival specimen or a fresh biopsy if archival tissue is unavailable) has been pathologically reviewed by a designated central laboratory confirming MAGE-A10 expression.
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- Subject has an ECOG Performance Status 0-1 and anticipated life expectancy >6 months prior to apheresis and >3 months prior to lymphodepletion.
- Subject is ≥18 to ≤75 years of age
- Adequate organ function
Who cannot join
- Subject is HLA-A*02:05, HLA-B*15:01 and/or HLA-B*46:01 positive.
- History of chronic or recurrent (within the last year prior to enrollment) severe autoimmune or active immune-mediated disease requiring steroids or other immunosuppressive treatments.
- Subject has symptomatic CNS metastases. Subjects with prior history of symptomatic CNS metastasis must have received treatment and be neurologically stable for at least 1 month prior to leukapheresis and lymphodepletion.
- Active malignancy besides NSCLC within 3 years prior to screening.
- Uncontrolled intercurrent illness including, but not limited to:
- Ongoing or active infection;
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- Clinically significant cardiac disease
- Inadequate pulmonary function
- Interstitial lung disease
Trial locations and contacts
19 sites in 4 countries.
19 sites in 4 countries
United States14 sites
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
University of Maryland, Greenebaum Cancer Center
Baltimore, Maryland, 21157
Massachusetts General Hospital
Boston, Massachusetts, 02114
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
City of Hope
Duarte, California, 91010
Duke University Medical Center, Duke Cancer Institute
Durham, North Carolina, 27710
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46033
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Tennessee Oncology- Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Stanford Cancer Center
Palo Alto, California, 94304
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Washington University, School of Medicine
St Louis, Missouri, 63110
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
Spain2 sites
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, 28040
Hospital Universitario 12 Octubre Avda. de Córdoba s/n
Madrid, Madrid, 28041
United Kingdom2 sites
University College Hospital Macmillan Cancer Centre
London, WC1E 6AG
The Christie NHS Foundation Trust
Manchester, M20 4BX
About this study
Official title: A Phase I Dose Escalation Open Label Clinical Trial Evaluating the Safety and Efficacy of MAGE A10ᶜ⁷⁹⁶T in Subjects With Stage IIIb or Stage IV Non-Small Cell Lung Cancer (NSCLC)
This first time in human study is intended for men and women at least 18 years of age who have advanced lung cancer which has grown or returned after being treated. In particular, it is a study for subjects who have a blood test positive for HLA-A*02:01 and/or HLA-A*02:06 and a tumor test positive for MAGE A10 protein expression (protein or gene). This trial is a dose escalation trial that will evaluate 3 doses of transduced cells administered after a lymphodepleting chemotherapy regimen using a 3+3 dose escalation design .The study will take the subject's T cells, which are a natural type of immune cell in the blood, and send them to a laboratory to be modified. The changed T cells used in this study will be the subject's own T cells that have been genetically changed with the aim of attacking and destroying cancer cells.
When the MAGE A10ᶜ⁷⁹⁶T cells are available, subjects will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by the T cell infusion. The purpose of this study is to test the safety of genetically changed T cells and find out what effects, if any, they have in subjects with lung cancer. The study will evaluate three different cell dose levels in order to find out the target cell dose. Once the target cell dose is determined, additional subjects will be enrolled to further test the safety and effects at this cell dose.
Subjects will be seen frequently by the Study Physician right after receiving their T cells back and up to first 6 months. After that, subjects will be seen every three months. Subjects will be seen every 6 months by their Study Physician for the first 5 years after the T cell infusion. If the T cells are found in the blood at five years, then the subjects will continue to be seen once a year until the T cells are no longer found in the blood for a maximum of 15 years. If the T cells are no longer found in the blood at 5 years, then the subject will be contacted by the Study Physician for the next 10 years. Subjects who have a confirmed response or clinical benefit ≥4 weeks after the first T-cell infusion and whose tumor continues to express the appropriate antigen target may be eligible for a second infusion. All subjects, completing or withdrawing from the Interventional Phase of the study, will enter a 15-year long-term follow-up phase for observation of delayed adverse events. All subjects will continue to be followed for overall survival during the long-term follow-up phase.
- Conditions
- Non-Small Cell Lung Cancer, Carcinoma
- Being tested
- Autologous Genetically modified T cells, MAGEA10ᶜ⁷⁹⁶T
- Keywords
- Previously Treated, Cell Therapy, T Cell Therapy, MAGE-A10, Immuno-oncology, T Cell Receptor, Metastatic
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Genetically modified T cells, MAGEA10ᶜ⁷⁹⁶TBiological
| Study group | Role | What they receive |
|---|---|---|
| Autologous Genetically modified T cells, MAGEA10ᶜ⁷⁹⁶T | Experimental | Not described Receives: Biological: Autologous Genetically modified T cells, MAGEA10ᶜ⁷⁹⁶T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with dose-limiting toxicity (DLT) and adverse events (AE), including serious adverse events (SAE)
Determine if treatment with autologous genetically modified T cells, (MAGE A10ᶜ⁷⁹⁶T ) is safe and tolerable through assessment of DLTs, AEs, including SAEs; laboratory assessments, including chemistry, hematology, and coagulation; cardiac and pulmonary assessments, including ECG and troponin.
Measured: 24 months
Secondary outcomes (8)
Proportion of subjects with a confirmed Complete Response (CR) or Partial Response (PR)
Evaluation of the efficacy of the treatment by assessment of the Overall Response Rate according to RECIST v1.1
Measured: 24 months
Interval between the date of first T cell infusion dose and first documented evidence of CR or PR
Evaluation of the efficacy of the treatment by assessment of time to first response
Measured: 24 months
Interval between the date of first documented evidence of CR or PR until first documented disease progression or death due to any cause
Evaluation of the efficacy of the treatment by assessment of duration of response
Measured: 24 months
Interval between the date of first documented evidence of SD until first documented disease progression or death due to any cause
Evaluation of the efficacy of the treatment by assessment of duration of stable disease
Measured: 24 months
Interval between the date of first T cell infusion and the earliest date of disease progression or death due to any cause
Evaluation of the efficacy of the treatment by assessment of progression-free survival
Measured: 24 months
Interval between the date of first T cell infusion and date of disease progression or death due to any cause
Evaluation of the efficacy of the treatment by assessment of overall survival
Measured: 24 months
Best Overall Response (BOR)
Best Overall Response (BOR), defined as the best response recorded from the date of T cell infusion until disease progression
Measured: 24 months
To evaluate potential gene therapy-related delayed adverse events for 15 years post infusion.
Presence of any of the following LTFU AEs:
- 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 Persistence of MAGE-A10c796T and replication-competent lentivirus (RCL) over time.
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startNov 2015
- Primary completion11 Mar 2020
- Study completion17 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adaptimmune
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ben Creelan, MD, MS, Study chair, H. Lee Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592577
- Sponsor's protocol ID
- ADP 0022-003
- Status last verified
- Dec 2025
- First submitted
- 20 Oct 2015
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Blumenschein GR, Devarakonda S, Johnson M, Moreno V, Gainor J, Edelman MJ, Heymach JV, Govindan R, Bachier C, Doger de Speville B, Frigault MJ, Olszanski AJ, Lam VK, Hyland N, Navenot JM, Fayngerts S, Wolchinsky Z, Broad R, Batrakou D, Pentony MM, Sanderson JP, Gerry A, Marks D, Bai J, Holdich T, Norry E, Fracasso PM. Phase I clinical trial evaluating the safety and efficacy of ADP-A2M10 SPEAR T cells in patients with MAGE-A10+ advanced non-small cell lung cancer. J Immunother Cancer. 2022 Jan;10(1):e003581. doi: 10.1136/jitc-2021-003581.
PubMed 35086946
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Open Label Clinical Trial Evaluating the Safety and Efficacy of MAGE A10ᶜ⁷⁹⁶T in Subjects With Stage IIIb or Stage IV Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT02592577
- Acronym / sponsor ID
- ADP 0022-003
- Conditions
- Non-Small Cell Lung Cancer, Carcinoma
- Keywords
- Previously Treated, Cell Therapy, T Cell Therapy, MAGE-A10, Immuno-oncology, T Cell Receptor, Metastatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- AdaptimmuneIndustry (pharma, biotech, devices)
- Study start
- Nov 2015 (actual)
- Primary completion
- 11 Mar 2020 (actual)
- Study completion
- 17 Mar 2021 (actual)
- First posted
- 30 Oct 2015 (estimated)
- 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.
This first time in human study is intended for men and women at least 18 years of age who have advanced lung cancer which has grown or returned after being treated. In particular, it is a study for subjects who have a blood test positive for HLA-A*02:01 and/or HLA-A*02:06 and a tumor test positive for MAGE A10 protein expression (protein or gene). This trial is a dose escalation trial that will evaluate 3 doses of transduced cells administered after a lymphodepleting chemotherapy regimen using a 3+3 dose escalation design .The study will take the subject's T cells, which are a natural type of immune cell in the blood, and send them to a laboratory to be modified. The changed T cells used in this study will be the subject's own T cells that have been genetically changed with the aim of attacking and destroying cancer cells.
When the MAGE A10ᶜ⁷⁹⁶T cells are available, subjects will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by the T cell infusion. The purpose of this study is to test the safety of genetically changed T cells and find out what effects, if any, they have in subjects with lung cancer. The study will evaluate three different cell dose levels in order to find out the target cell dose. Once the target cell dose is determined, additional subjects will be enrolled to further test the safety and effects at this cell dose.
Subjects will be seen frequently by the Study Physician right after receiving their T cells back and up to first 6 months. After that, subjects will be seen every three months. Subjects will be seen every 6 months by their Study Physician for the first 5 years after the T cell infusion. If the T cells are found in the blood at five years, then the subjects will continue to be seen once a year until the T cells are no longer found in the blood for a maximum of 15 years. If the T cells are no longer found in the blood at 5 years, then the subject will be contacted by the Study Physician for the next 10 years. Subjects who have a confirmed response or clinical benefit ≥4 weeks after the first T-cell infusion and whose tumor continues to express the appropriate antigen target may be eligible for a second infusion. All subjects, completing or withdrawing from the Interventional Phase of the study, will enter a 15-year long-term follow-up phase for observation of delayed adverse events. All subjects will continue to be followed for overall survival during the long-term follow-up phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous Genetically modified T cells, MAGEA10ᶜ⁷⁹⁶T | Experimental | Biological: Autologous Genetically modified T cells, MAGEA10ᶜ⁷⁹⁶T |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject has histologically or cytologically confirmed diagnosis of advanced non-small cell lung cancer (stage IIIB or IV) or recurrent disease
- Subject has received at least one line of prior therapy
- Subjects with known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase receptor (ALK) or ROS1 gene rearrangements must have failed (progressive disease or unacceptable toxicity) at least one prior EGFR or ALK or ROS1 tyrosine kinase inhibitor, respectively. Subject may have received PD-1 or PDL-1 inhibitors and or chemotherapy. There is no limit on lines of prior anti-cancer therapy (a washout period applies for recent anti-cancer treatments).
- Subject has measurable disease according to RECIST v1.1 criteria prior to lymphodepletion.
- Subject is HLA-A*02:01 or HLA-A*02:06 positive.
Key exclusion criteria (9 listed)
- Subject is HLA-A*02:05, HLA-B*15:01 and/or HLA-B*46:01 positive.
- History of chronic or recurrent (within the last year prior to enrollment) severe autoimmune or active immune-mediated disease requiring steroids or other immunosuppressive treatments.
- Subject has symptomatic CNS metastases. Subjects with prior history of symptomatic CNS metastasis must have received treatment and be neurologically stable for at least 1 month prior to leukapheresis and lymphodepletion.
- Active malignancy besides NSCLC within 3 years prior to screening.
- Uncontrolled intercurrent illness including, but not limited to:
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 |
|---|---|---|
| Autologous Genetically modified T cells, MAGEA10ᶜ⁷⁹⁶T | Biological | Autologous Genetically modified T cells, MAGEA10ᶜ⁷⁹⁶T |
Primary outcome
Number of subjects with dose-limiting toxicity (DLT) and adverse events (AE), including serious adverse events (SAE)
Time frame: 24 months
Determine if treatment with autologous genetically modified T cells, (MAGE A10ᶜ⁷⁹⁶T ) is safe and tolerable through assessment of DLTs, AEs, including SAEs; laboratory assessments, including chemistry, hematology, and coagulation; cardiac and pulmonary assessments, including ECG and troponin.
8 secondary outcomes
Proportion of subjects with a confirmed Complete Response (CR) or Partial Response (PR)
Time frame: 24 months
Interval between the date of first T cell infusion dose and first documented evidence of CR or PR
Time frame: 24 months
Interval between the date of first documented evidence of CR or PR until first documented disease progression or death due to any cause
Time frame: 24 months
Interval between the date of first documented evidence of SD until first documented disease progression or death due to any cause
Time frame: 24 months
Interval between the date of first T cell infusion and the earliest date of disease progression or death due to any cause
Time frame: 24 months
Interval between the date of first T cell infusion and date of disease progression or death due to any cause
Time frame: 24 months
Best Overall Response (BOR)
Time frame: 24 months
To evaluate potential gene therapy-related delayed adverse events for 15 years post infusion.
Time frame: 15 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Derived from this study: PubMed 35086946Blumenschein GR, Devarakonda S, Johnson M, Moreno V, Gainor J, Edelman MJ, Heymach JV, Govindan R, Bachier C, Doger de Speville B, Frigault MJ, Olszanski AJ, Lam VK, Hyland N, Navenot JM, Fayngerts S, Wolchinsky Z, Broad R, Batrakou D, Pentony MM, Sanderson JP, Gerry A, Marks D, Bai J, Holdich T, Norry E, Fracasso PM. Phase I clinical trial evaluating the safety and efficacy of ADP-A2M10 SPEAR T cells in patients with MAGE-A10+ advanced non-small cell lung cancer. J Immunother Cancer. 2022 Jan;10(1):e003581. doi: 10.1136/jitc-2021-003581.
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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.
Ben Creelan, MD, MS study chair
H. Lee Moffitt Cancer Center
19 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous Genetically modified T cells, MAGEA10ᶜ⁷⁹⁶T in people with Non-Small Cell Lung Cancer and Carcinoma, run by Adaptimmune at 19 sites in 4 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 9 inclusion and 9 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: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Spain, United Kingdom, 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 dose-limiting toxicity (DLT) and adverse events (AE), including serious adverse events (SAE) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02592577, which also lists 1 linked publication.
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 9 Dec 2025.