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ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Esophageal or Esophagogastric Junction Cancers (SURPASS-2)

Sponsor
Adaptimmune (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04752358
Collaborator
ICON plc (Industry)
45
Enrollment
34
Locations
1
Arm
204.5
Anticipated Duration (Months)
1.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Genetic: Autologous genetically modified ADP-A2M4CD8 cells
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 :
Sep 15, 2021
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Oct 1, 2038

Arms and Interventions

Arm Intervention/Treatment
Experimental: Autologous genetically modified ADP-A2M4CD8 cells

Genetic: Autologous genetically modified ADP-A2M4CD8 cells
Infusion of autologous genetically modified ADP-A2M4CD8 on Day 1

Outcome Measures

Primary Outcome Measures

  1. Efficacy: Overall Response Rate (ORR) [2.5 Years]

    ORR is defined as incidence of complete responses or partial responses as assessed by RECIST v1.1

Secondary Outcome Measures

  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 [2.5 years]

    Determine if treatment with ADP-A2M4CD8 is safe and tolerable through assessment of adverse events (AEs) including Serious Adverse Events (SAEs)

  2. Efficacy: Best overall response (BOR) [2.5 Years]

    Best Overall Response (BOR) is per RECIST V1.1.

  3. Time to response (TTR) [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.

  4. Duration of Response (DoR) [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.

  5. Progression Free Survival (PFS) [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.

  6. Overall Survival (OS) [15 years]

    OS is assessed from date of infusion of ADP-A2M4CD8 up until the date of patient death.

  7. Invitro diagnostic (IVD) assay for screening [2.5 years]

    Development and validation of the MAGE-A4 antigen expression companion diagnostic assay

  8. Time taken to achieve peak expansion of genetically engineered T-cells in PBMCs [2.5 years]

    Time taken to achieve peak expansion of genetically engineered T-cells in PBMCs by flow cytometry

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
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 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 City of Hope National Medical Center Duarte California United States 91010
2 Mayo Clinic Jacksonville Florida United States 32224
3 Northwestern Medical Faculty Foundation Chicago Illinois United States 60611
4 University of Chicago Medicine Chicago Illinois United States 60637
5 Simon Cancer Center-Indiana University Indianapolis Indiana United States 46202
6 University of Kansas Clinical Research Center Fairway Kansas United States 66205
7 Massachusetts General Hospital Boston Massachusetts United States 02114
8 Mayo Clinic Rochester Minnesota United States 55905
9 Washington University School of Medicine- Siteman Cancer Center Saint Louis Missouri United States 63110
10 Memorial Sloan Kettering Cancer Center New York New York United States 10065
11 Duke University Medical Center Durham North Carolina United States 27710
12 OU Health Stephenson Cancer Center Oklahoma City Oklahoma United States 73104
13 Providence Cancer Institute Franz Clinic Portland Oregon United States 97213
14 UT Southwestern Medical Center Dallas Texas United States 75390
15 University Of Texas, MD Anderson Cancer Center Houston Texas United States 77030
16 University Of Wisconsin Clinical Science Center Madison Wisconsin United States 53792
17 Froedtert Hospital and Medical College of Wisconsin Milwaukee Wisconsin United States 53226
18 Princess Margaret Cancer Centre Toronto Ontario Canada M5G 2M9
19 McGill University Health Centre Glen Site Montreal Quebec Canada H4A 3J1
20 Hopital Huriez Lille Cedex France 59037
21 Centre Leon-Berard (CLB) - Centre de Recherche en Cancerologie Lyon-Est (CRCL) Lyon Cedex France 69008
22 Centre Eugene Marquis Rennes Cedex France 35062
23 Institut Gustave Roussy Vaillant Villejuif France 94805
24 Hospital Universitari Vall d'Hebron la Vall d'Hebron Barcelona Spain 08035
25 Hospital Universitario 12 de Octubre Córdoba Madrid Spain 28041
26 Hospital Clinico Universitario de Valencia Ibáñez Valencia Spain 46010
27 Hospital Fundacion Jimenez Diaz Madrid Spain 228040
28 Hospital Universitario Madrid Sanchinarro (CIOCC) Madrid Spain 28050
29 Clinica Universidad de Navarra Navarro Spain 31008
30 Hospital Universitario Virgen del Rocio Sevilla Spain 41013
31 The Christie NHS Foundation Trust Withington Manchester United Kingdom M20 4BX
32 Beatson West of Scotland Cancer Centre Glasgow Scotland United Kingdom G12 0YN
33 University College Hospital London United Kingdom NW2 1PG
34 Guy's Hospital-Guy's and St Thomas NHS Foundation Trust London United Kingdom SE1 9RT

Sponsors and Collaborators

  • Adaptimmune
  • ICON plc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Adaptimmune
ClinicalTrials.gov Identifier:
NCT04752358
Other Study ID Numbers:
  • ADP-0055-002
First Posted:
Feb 12, 2021
Last Update Posted:
Aug 24, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Adaptimmune
Cell Therapy
T Cell Therapy
SPEAR T Cell
MAGE-A4
Immuno-oncology
Metastatic
Esophagogastric Junction
Esophageal Cancer
Additional relevant MeSH terms:
Esophageal Neoplasms

Study Results

No Results Posted as of Aug 24, 2022