Clinical trial · Interventional
ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Esophageal or Esophagogastric Junction Cancers (SURPASS-2)
A Phase 2 Open-Label Clinical Trial of ADP-A2M4CD8 in Subjects With Advanced Esophageal or Esophagogastric Junction Cancers
NCT04752358CI-TRIAL-00080407terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was terminated due to difficulty recruiting subjects and lack of efficacy
Summary
Brief summary (as posted)
This study will investigate the efficacy of ADP-A2M4CD8 T-cell therapy in subjects who have the appropriate human leukocyte antigen (HLA) and tumor antigen status and whose esophageal or esophagogastric junction (EGJ) cancer expresses the MAGE-A4 protein.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Esophagogastric Junction Cancer | Esophageal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous genetically modified ADP-A2M4CD8 cells | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Autologous genetically modified ADP-A2M4CD8 cells
- interventionNames
- Genetic: Autologous genetically modified ADP-A2M4CD8 cells
Primary outcomes (1)
- measure
- Overall Response Rate (ORR) by Independent Radiological Assessment Committee (IRAC)
- timeFrame
- From T-cell infusion to end of Interventional Phase (Up to 5 months from T-cell infusion).
- description
- Confirmed tumor response (complete response \[CR\] or partial response \[PR\]) to treatment as assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by IRAC
Secondary outcomes (16)
- measure
- Number and Percentage of Participants With Adverse Events (AEs) Including Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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 1. Positive for any HLA-A\*02 allele other than: one of the inclusion alleles 2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study 3. Active autoimmune or immune mediated disease 4. Leptomeningeal disease, carcinomatous meningitis or symptomatic CNS metastases 5. Other prior malignancy that is not considered by the Investigator to be in complete remission. Clinically significant cardiovascular disease 6. Uncontrolled intercurrent illness 7. Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus 8. Pregnant or breastfeeding Note: other protocol defined Inclusion/Exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.