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Brief Title: MAGE-A10ᶜ⁷⁹⁶T for Urothelial Cancer, Melanoma or Head and Neck Cancers

Phase 1 Cell Dose Escalation Study to Assess the Safety and Tolerability of Genetically Engineered MAGE-A10ᶜ⁷⁹⁶T in HLA-A2+ Subjects With MAGE-A10 Positive Urothelial, Melanoma or Head and Neck Tumors

INTRODUCTION

  • Org Study ID: ADP-0022-004
  • Secondary ID: N/A
  • NTC ID: NCT02989064
  • Sponsor: Adaptimmune

BRIEF SUMMARY


This Phase 1 study is designed as a cell dose escalation trial in HLA-A*02:01 and HLA-A*02:06
subjects with MAGE-A10 positive urothelial, melanoma or head and neck tumors. The study will
enroll subjects at least 18 years of age using a modified 3+3 cell dose escalation design, to
evaluate dose limiting toxicities and determine the target cell dose range. Following the
dose escalation phase, additional subjects will be enrolled at the target cell dose range to
further characterize safety and the effects at this cell dose.

The study will take the subject's T cells, which are a natural type of immune cell in the
blood, and send them to a laboratory to be modified. The changed T cells used in this study
will be the subject's own T cells that have been genetically changed with the aim of
attacking and destroying cancer cells. When the MAGE-A10ᶜ⁷⁹⁶T cells are available, subjects
will undergo lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by
T cell infusion. The purpose of this study is to test the safety of genetically changed T
cells and find out what effects, if any, they have in subjects with urothelial, melanoma or
head and neck cancer.

Subjects will be seen frequently by the Study Physician after receiving their T cells for the
next 6 months. After that, subjects will be seen every 3, 6, or 12 months according to the
Schedule of Procedures. All subjects completing or withdrawing from the interventional
portion of the study will enter a long term follow-up phase for observation of delayed
adverse events and overall survival for 15 years post-infusion.


  • Overall Status
    Recruiting
  • Start Date
    October 2016
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

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

Primary Outcome 1 - Timeframe: 3 years

Primary Outcome 2 - Measure: Evaluation of the persistence of genetically modified T cells

Primary Outcome 2 - Timeframe: 3 years

Primary Outcome 3 - Measure: Measurement of RCL in genetically modified T cells.

Primary Outcome 3 - Timeframe: 3 years

Primary Outcome 4 - Measure: Assessment of dose limiting toxicities to determine optimally tolerated dose range

Primary Outcome 4 - Timeframe: 3 years

Primary Outcome 5 - Measure: Proportion of subjects with a confirmed Complete Response (CR) and/or Partial Response (PR).

Primary Outcome 5 - Timeframe: 3 years

Primary Outcome 6 - Measure: Interval between the date of first T cell infusion dose and first documented evidence of CR or PR.

Primary Outcome 6 - Timeframe: 3 years

Primary Outcome 7 - Measure: Interval between the date of first documented evidence of CR or PR until first documented disease progression or death due to any cause.

Primary Outcome 7 - Timeframe: 3 years

Primary Outcome 8 - Measure: Interval between the date of first documented evidence of SD until first documented disease progression or death due to any cause.

Primary Outcome 8 - Timeframe: 3 years

Primary Outcome 9 - Measure: Interval between the date of first T cell infusion and the earliest date of disease progression or death due to any cause

Primary Outcome 9 - Timeframe: 3 years

Primary Outcome 10 - Measure: Interval between the date of first T cell infusion and date of death due to any cause.

Primary Outcome 10 - Timeframe: 3 years

Primary Outcome 11 - Measure: Number and % of subjects having any Long Term Follow Up Adverse Events (AEs)

Primary Outcome 11 - Timeframe: 15 years post last treatment (infusion)

CONDITION

  • Urothelial Carcinoma
  • Head and Neck Cancer
  • Melanoma
  • Bladder Urothelial Carcinoma

ELIGIBILITY


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:
(A) urothelial cancer (transitional cell cancer of the bladder, ureter or renal
pelvis), (B) melanoma, or (C) squamous cell carcinoma of the head and neck.

3. Subject is HLA-A*02:01 and/or HLA-A*02:06 positive.

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 in either allele, HLA-B*15:01 and/or HLA-B*46:01 positive.
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.

Gender: All

Minimum Age: N/A

Maximum Age: 18 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: 713-563-1930

Email: N/A

LOCATION

Facility Status Contact
Facility: Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Status: Recruiting Contact:
Ryan Sullivan, MD
617-724-4000
rsullivan7@partners.org
Facility: Washington University - School of Medicine
Saint Louis, Missouri 63110
United States
Status: Recruiting Contact:
Nic Perry
314-273-2831
nperry@wustl.edu
Facility: Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Status: Recruiting Contact:
Amy Whitworth
716-845-3089
Amy.Whitworth@roswellpark.org
Facility: Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United States
Status: Recruiting Contact:
Elisabeth Giraud

Elisabeth.Giraud@fccc.edu
Facility: Tennessee Oncology - Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States
Status: Recruiting Contact:

615-339-4214
asksarah@sarahcannon.com
Facility: MD Anderson Cancer Center
Houston, Texas 77030
United States
Status: Recruiting Contact:
Danxia Ke
713-792-4384
dke@mdanderson.org
Facility: Princess Margaret Cancer Centre
Toronto, Ontario M5G1X6
Canada
Status: Recruiting Contact:
Adrian G Sacher, MD
416-946-4501
TIP@uhn.ca
Facility: Hospital Universitario 12 Octubre Avda. de Córdoba
Madrid, 28041
Spain
Status: Recruiting Contact:
Sandra de la Llave Corredor
91 390 89 22
sllave.imas12@h12o.es