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BRIEF TITLE: Study to Assess the Safety, Tolerability and Antitumor Activity of Genetically Engineered MAGE-A4ᶜ¹º³²T in HLA-A2+ Subjects With MAGE-A4 Positive Tumors

Phase 1 Dose Escalation, Multi-tumor Study to Assess the Safety, Tolerability and Antitumor Activity of Genetically Engineered MAGE-A4ᶜ¹º³²T in HLA-A2+ Subjects With MAGE-A4 Positive Tumors


  • Org Study ID: ADP-0044-001
  • Secondary ID:
  • NCT ID: NCT03132922
  • NCT Alias:
  • Sponsor: Adaptimmune - Industry
  • Source: Adaptimmune

Brief Summary

This study will investigate the safety and tolerability of MAGE-A4ᶜ¹º³²T cell therapy in subjects who have the appropriate HLA-A2 tissue marker and whose urinary bladder, melanoma, head and neck, ovarian, non-small cell lung, esophageal, gastric, synovial sarcoma, or myxoid/round call liposarcoma (MRCLS) tumor has the MAGE-A4 protein expressed. This study will take a subject's T cells and give them a T cell receptor protein that recognizes and attacks the tumors. This study has a substudy component that will investigate the safety and tolerability of MAGE-A4c1032T cell therapy in combination with low dose radiation in up to 10 subjects.

Overal Status Start Date Phase Study Type
Recruiting May 15, 2017 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Number of subjects with adverse events (AE), including serious adverse events (SAEs).

Primary Outcome 1 - Time Frame: 3.5 years

Primary Outcome 2 - Measure: Determining dose limiting toxicities (DLT) and optimally tolerated dose range

Primary Outcome 2 - Time Frame: 3.5 years

Primary Outcome 3 - Measure: Evaluation of persistence of genetically modified T cells.

Primary Outcome 3 - Time Frame: 3.5 years

Primary Outcome 4 - Measure: Measurement of RCL in genetically modified T cells.

Primary Outcome 4 - Time Frame: 3.5 years

Condition:

  • Urinary Bladder Cancer
  • Melanoma
  • Head and Neck Cancer
  • Ovarian Cancer
  • Non-Small Cell Lung Cancer
  • Esophageal Cancer
  • Gastric Cancer
  • Synovial Sarcoma
  • Myxoid Round Cell Liposarcoma
  • Gastroesophageal Junction

Eligibility

Criteria:
Inclusion Criteria:

1. Subject is ≥18 years of age at the time of signing the study informed consent.

2. Subject has histologically confirmed diagnosis of any one of the indicated tumor types

3. Subject is HLA-A*02 positive. (This determination will be made under screening
protocol ADP-0000-001).

4. Subject's tumor shows expression of the MAGE-A4 RNA or protein. (This determination
will be made under screening protocol ADP-0000-001).

5. Adequate organ function as indicated in the study protocol

6. Subject has measurable disease according to RECIST v1.1 criteria prior to
lymphodepletion

7. Subject meets disease-specific requirements per protocol

7. Subject has anticipated life expectancy > 6 months prior to leukapheresis and >3 months
prior to lymphodepletion.

Exclusion Criteria:

1. Subject does not express appropriate HLA-A genotype

2. Subject is receiving excluded therapy/treatment per protocol

3. Subject has symptomatic CNS metastases.

4. Subject has any other active malignancy besides the tumor under study within 3 years
prior to Screening. Subject has uncontrolled intercurrent illness.

5. Subject has active infection with HIV, HBV, HCV or HTLV

6. Subject is pregnant or breastfeeding.

Additional Exclusion Criteria for the Radiation Substudy:

- Subject does not meet eligibility criteria for the main study (ADP-0044-001).

- Subject does not have at least one target lesion amenable to radiation.

- Certain radiation therapy within 6 months of clinical trial are an exclusion.

- Metastatic disease impinging on the spinal cord or threatening spinal cord
compression.
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Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Official Information

Name: David Hong, MD

Role: Principal Investigator

Affiliation: M.D. Anderson Cancer Center

Overall Contact

Name: David Hong, MD

Phone: 713-563-5844

Email: dshong@madanderson.org

Locations

Facility Status Contact
University of Miami
Miami, Florida 33136
United States
Completed
Moffitt Cancer Center
Tampa, Florida 33612
United States
Completed
Washington University School of Medicine
Saint Louis, Missouri 63110
United States
Recruiting Michelle Landeau
314-747-7997
landeaum@wustl.edu
Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Recruiting Amy Whitworth, BSN
716-845-8409
Amy.Whitworth@roswellpark.org
Duke University Medical Center, Duke Cancer Institute
Durham, North Carolina 27710
United States
Recruiting Shawna Savage, RN, BSN
919-668-1462
shawna.savage@duke.edu
Ohio State University Wexner Medical Center
Columbus, Ohio 43210
United States
Recruiting Catherine Schweitzer
614-685-5414
catherine.schweitzer@osumc.edu
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United States
Recruiting Anthony Olszanski, MD, RPh

Anthony.Olszanski@FCCC.edu
Tennessee Oncology - Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States
Recruiting Matt Walker
615-339-4214
asksarah@sarahcannon.com
M.D. Anderson Cancer Center
Houston, Texas 77030
United States
Recruiting Danxia Ke
713-792-4384
dke@mdanderson.org
Princess Margaret Cancer Centre
Toronto, Ontario M5G1X6
Canada
Recruiting Adrian Sacher, MD
416-946-4501
TIP@uhn.ca