ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Esophageal or Esophagogastric Junction Cancers (SURPASS-2)
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|ClinicalTrials.gov Identifier: NCT04752358|
Recruitment Status : Active, not recruiting
First Posted : February 12, 2021
Last Update Posted : April 18, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer Esophagogastric Junction Cancer||Genetic: Autologous genetically modified ADP-A2M4CD8 cells||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Open-Label Clinical Trial of ADP-A2M4CD8 in Subjects With Advanced Esophageal or Esophagogastric Junction Cancers|
|Actual Study Start Date :||September 15, 2021|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||December 31, 2023|
|Experimental: Autologous genetically modified ADP-A2M4CD8 cells||
Genetic: Autologous genetically modified ADP-A2M4CD8 cells
Infusion of autologous genetically modified ADP-A2M4CD8 on Day 1
- Efficacy: Overall Response Rate (ORR) [ Time Frame: 2.5 Years ]ORR is defined as incidence of complete responses or partial responses as assessed by RECIST v1.1
- Number of subjects with treatment -related adverse events (AEs), including serious adverse events (SAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 [ Time Frame: 2.5 years ]Determine if treatment with ADP-A2M4CD8 is safe and tolerable through assessment of adverse events (AEs) including Serious Adverse Events (SAEs)
- Efficacy: Best overall response (BOR) [ Time Frame: 2.5 Years ]Best Overall Response (BOR) is per RECIST V1.1.
- Time to response (TTR) [ Time Frame: 2.5 years ]For patients who are observed to respond to ADP-A2M4CD8, the time taken from date of infusion to achieve a partial response or complete response (TTR) is assessed.
- Duration of Response (DoR) [ Time Frame: 2.5 years ]For patients who are observed to respond to ADP-A2M4CD8, the DoR is the date of initial response (including confirmation) from date of infusion up until disease progression per RECIST v 1.1 or death.
- Progression Free Survival (PFS) [ Time Frame: 2.5 years ]PFS is assessed from date of infusion of ADP-A2M4CD8 up until the date of disease progression per RECIST v1.1 or death.
- Overall Survival (OS) [ Time Frame: 15 years ]OS is assessed from date of infusion of ADP-A2M4CD8 up until the date of patient death.
- Invitro diagnostic (IVD) assay for screening [ Time Frame: 2.5 years ]Development and validation of the MAGE-A4 antigen expression companion diagnostic assay
- Time taken to achieve peak expansion of genetically engineered T-cells in PBMCs [ Time Frame: 2.5 years ]Time taken to achieve peak expansion of genetically engineered T-cells in PBMCs by flow cytometry
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|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Key Inclusion Criteria:
- Age ≥18 and <75 years
- Diagnosis of Esophageal cancer or Esophagogastric junction cancer.
- Previously received treatment for advanced or metastatic disease.
- Measurable disease according to RECIST v1.1.
- HLA-A*02 positive
- Tumor shows MAGE-A4 expression confirmed by central laboratory.
- ECOG Performance Status of 0 or1.
- Left ventricular ejection fraction (LVEF) ≥50%.
Note: other protocol defined Inclusion criteria may apply
Key exclusion criteria
- Positive for any HLA-A*02 allele other than: one of the inclusion alleles
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study
- Active autoimmune or immune mediated disease
- Leptomeningeal disease, carcinomatous meningitis or symptomatic CNS metastases
- Other prior malignancy that is not considered by the Investigator to be in complete remission. Clinically significant cardiovascular disease
- Uncontrolled intercurrent illness
- Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus
- Pregnant or breastfeeding
Note: other protocol defined Inclusion/Exclusion criteria may apply.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04752358
|Other Study ID Numbers:||
|First Posted:||February 12, 2021 Key Record Dates|
|Last Update Posted:||April 18, 2023|
|Last Verified:||April 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
T Cell Therapy
SPEAR T Cell
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases