Safety and Efficacy of MAGE-A3/A6 T Cell Receptor Engineered T Cells (KITE-718) in HLA-DPB1*04:01 Positive Adults With Advanced Cancers



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/30/2019
Start Date:May 8, 2017
End Date:March 2036
Contact:Medical Information
Email:medinfo@kitepharma.com
Phone:1-844-454-5483(1-844-454-KITE)

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A Phase 1 Study Evaluating the Safety and Efficacy of MAGE-A3/A6 T Cell Receptor Engineered T Cells (KITE-718) in HLA-DPB1*04:01 Positive Subjects With Advanced Cancers

The primary objectives of Phase 1A are to evaluate the safety of KITE-718, determine a
recommended Phase 1B dose, and to evaluate the efficacy of KITE-718 in Phase 1B.

Participants found to be human leukocyte antigen (HLA)-DPB1*04:01 positive and whose tumors
are MAGE-A3 and/or MAGE-A6 positive can participate if all eligibility criteria are met.
Other tests required to determine eligibility include a physical exam, electrocardiogram
(ECG) and echocardiogram (ECHO) of the heart, CT or MRI scans, and blood draws. Eligible
participants have white blood cells collected by leukapheresis. These cells are genetically
modified to make the experimental treatment KITE-718. The desired outcome is that the
genetically modified T cells will target tumor cells that express MAGE-A3 and/or MAGE-A6,
which are proteins that can be expressed by cancer cells. Participants receive chemotherapy
prior to the KITE-718 infusion. After the KITE-718 infusion, participants will be followed
for side effects and have scans performed to see any potential impact on their cancers. Study
procedures may be performed while hospitalized and/or in the outpatient setting.

Key Inclusion Criteria:

- Age ≥ 18 years

- Relapsed or refractory disease after a systemic standard of care treatment regimen
and, if available, at least one standard of care salvage regimen

- MAGE-A3/A6 positive tumor

- HLA-DPB1*04:01 positive

- At least 1 measurable lesion on CT or MRI

- No evidence of central nervous system (CNS) disease by MRI or CT of the brain. Note:
Prior brain metastasis which have been treated with definitive therapy are eligible.

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Toxicities due to prior therapy must be recovered to baseline or ≤ grade 1, except for
clinically non-significant toxicities such as alopecia

- Adequate bone marrow function as evidenced by:

- Absolute neutrophil count (ANC) ≥ 1000/mm^3

- Platelet ≥ 100/mm^3

- Hemoglobin > 8 g/dL

- Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by:

- Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 cc/min

- Alanine transaminase (ALT)/aspartate aminotransferase (AST) ≤ 2.5 x upper limit
normal (ULN) or ≤ 5 x ULN if documented liver metastases

- Total bilirubin ≤ 1.5 mg/dL

- Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as
determined by an ECHO, and no clinically significant ECG findings

- No clinically significant pleural effusion

- Baseline oxygen saturation > 92% on room air

Key Exclusion Criteria:

- Malignancy other than non-melanoma skin cancer, carcinoma in situ, or low grade
prostate cancer for which watch-and-wait approach is standard of care, unless disease
free for at least 3 years

- Clinically significant cardiac disease within last 12 months

- Stroke or transient ischemic attack (TIA) within 12 last months

- Symptomatic deep vein thrombosis or pulmonary embolism within last 6 months

- Prior MAGE-A3/A6-targeting therapy

- Live vaccine ≤ 4 weeks prior to enrollment

- Systemic corticosteroid therapy within 7 days before enrollment.

- History of severe, immediate hypersensitivity reaction attributed to aminoglycosides

- Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials
for management.

- Presence of any indwelling line or drain. Note: Dedicated central venous access
catheters such as a Port-a-Cath are permitted.

- Primary immunodeficiency

- Autoimmune disease resulting in end-organ injury or requiring systemic
immunosuppression/systemic disease modifying agents within the last 2 years prior to
enrollment

- Known history of infection with HIV, hepatitis B (HBsAg positive), or hepatitis C
(anti-HCV positive). A history of treated hepatitis B or hepatitis C is permitted if
the viral load is undetectable per quantitative polymerase chain reaction (PCR) and/or
nucleic acid testing.

- Females who are pregnant as confirmed by a positive serum or urine pregnancy test or
are breastfeeding.

- Individuals of both genders of child-bearing potential who are not willing to practice
birth control from the time of consent through 6 months after the completion of
KITE-718

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
10
sites
1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Chris Klebanoff, MD
Phone: 646-888-4593
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Marcela Maus, MD, PhD
Phone: 617-724-9190
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Boston, MA
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Dallas, Texas 75246
Principal Investigator: Carlos Becerra, MD
Phone: 214-370-1254
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Dallas, TX
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: Partow Kebriaei, MD
Phone: 713-563-2169
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
Principal Investigator: David Quinn, MD
Phone: 323-865-0593
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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Los Angeles, California 90095
Principal Investigator: Alexandra Drakaki, MD
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Miami, Florida 33136
Principal Investigator: Peter Hosein, MD
Phone: 301-243-7648
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Principal Investigator: Ash Tewari, MD
Phone: 212-241-9955
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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New York, NY
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Sacramento, California 95817
Principal Investigator: Mehrdad Abedi, MD
Phone: 916-734-0561
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Tampa, Florida 33612
Principal Investigator: Benjamin Creelan, MD
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Tampa, FL
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