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Brief Title: MAGE-A4ᶜ¹º³²T for Multi-Tumor

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

INTRODUCTION

  • Org Study ID: ADP-0044-001/RSS
  • Secondary ID: N/A
  • NCT ID: NCT03132922
  • Sponsor: 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.

  • Overall Status
    Active, not recruiting
  • Start Date
    May 15, 2017
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

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

Inclusion Criteria:
1. Subject is ≥18 to 75 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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: David Hong, MD

Role: Principal Investigator

Affiliation: M.D. Anderson Cancer Center

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact

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