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BRIEF TITLE: 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

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.

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

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 following cancers:
urothelial cancer (transitional cell cancer of the bladder, ureter, urethra or renal
pelvis), melanoma, squamous cell carcinoma of the head and neck, ovarian cancer, NSCLC
(squamous, adenosquamous, or large cell), esophageal (squamous and adenocarcinoma) or
gastric cancer, synovial sarcoma or MRCLS.

3. Subject is HLA-A*02 positive and subject's tumor shows expression of the MAGE-A4 RNA
or protein.

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

5. Subject meets disease-specific requirements per protocol

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

Exclusion Criteria:

1. Subject is HLA-A*02:05 positive in either allele; Subject has HLA-A*02:07 as the sole
HLA-A*02 allele (e.g., a subject with HLA alleles A*02:04 and A*02:07 is eligible); or
Subject has any A*02 null allele (designated with an N", e.g., A*02:32N) as the sole
HLA-A*02 allele

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.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Locations

Facility Status Contact
University of Miami
Miami, Florida 33136
United States
Recruiting Michelle Liendo, MSHI
305-243-0864
mliendo@med.miami.edu
Washington University School of Medicine
Saint Louis, Missouri 63110
United States
Recruiting Melissa Meredith
314-362-4140
melissa.meredith@wustl.edu
Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Recruiting Amy Whitworth, BSN
716-845-8409
Amy.Whitworth@roswellpark.org
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United States
Recruiting Patti Kelly
215-728-2195
Patriciamurphy@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 Marcus Butler, MD
416-946-4501
TIP@uhn.ca