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

Status:	Recruiting
Conditions:	Prostate Cancer, Skin Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	2/22/2019
Start Date:	October 2016
End Date:	November 2034
Contact:	David Hong, MD
Phone:	713-563-1930

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

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.

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.

We found this trial at

sites

Washington University School of Medicine

660 S Euclid Ave
Saint Louis, Missouri 63110

(314) 362-5000