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Solid TumorPhase 1NCT03139370

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

A Phase 1 study testing KITE-718, Cyclophosphamide and Fludarabine in people with Solid Tumor, run by Kite, A Gilead Company at 12 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor
What is being tested?
KITE-718, Cyclophosphamide and Fludarabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
12 sitesUnited States
Study dates
27 Dec 2017to 4 Jun 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Advanced cancer defined as relapsed or refractory disease after a systemic standard of care treatment regimen and, if available, at least one standard of care salvage regimen unless the subject refuses such therapy. Multiple myeloma (MM) subjects must have had both a protease inhibitor (PI) and immunomodulatory drugs (IMiD) as part of the last regimen, or at least 3 prior lines of therapy, including a PI and an IMiD. Additionally, subjects must not have disease amenable to definitive locoregional therapy.
  • MAGE-A3/A6 positive tumor as confirmed by the central laboratory
  • 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 provided that the definitive therapy was completed more than six months prior to screening.
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  • 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 (24-hour urine creatinine clearance is also acceptable)
  • 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 (For ejection fraction only, MUGA scan is also acceptable)
  • No clinically significant pleural effusion
  • Baseline oxygen saturation > 92% on room air

Who cannot join

  • 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, catheter associated thrombosis is not included as exclusion criteria.
  • Prior T-cell therapy, including KITE-718 or MAGE-A3/A6-targeting therapy.
  • Live vaccine ≤ 4 weeks prior to enrollment
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  • 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 or Hickman catheter as well as feeding tubes such as a G-tube, 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.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • University of Chicago

    Chicago, Illinois, 60640

  • Baylor Scott & White Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • UCLA Hematology/Oncology

    Los Angeles, California, 90095

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • University of Utah, Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • H. Lee Moffitt Cancer and Research Institute

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: 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.

Read the detailed description

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. Subjects who received an infusion of KITE-718 will complete the remainder of the 15 year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968

Conditions
Solid Tumor
Being tested
KITE-718, Cyclophosphamide, Fludarabine, MAGE - A3/A6 Screening Test

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KITE-718Drug

    A single infusion of autologous genetically modified MAGE-A3/A6 T-cell receptor (TCR) transduced autologous T cells (KITE-718).

  • CyclophosphamideDrug

    Administered intravenously

  • FludarabineDrug

    Administered intravenously

  • MAGE - A3/A6 Screening TestDevice

    A screening test for MAGE-A3/A6+ tumors

Study groups in NCT03139370
Study groupRoleWhat they receive
KITE-718ExperimentalPhase 1A: Participants will receive cyclophosphamide and fludarabine conditioning chemotherapy followed by the investigational treatment, KITE-718. Phase 1 B: Participants will receive cyclophosphamide and fludarabine conditioning chemotherapy followed by the investigational treatment, KITE-718, at a dose selected based on Phase 1A.
Receives: Drug: KITE-718; Drug: Cyclophosphamide; Drug: Fludarabine; Device: MAGE - A3/A6 Screening Test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1A - Percentage of Participants Experiencing Adverse Events Defined as Dose-Limiting Toxicities

    Dose-limiting toxicity is defined as protocol-defined KITE-718 related events with onset within the first 21 days following KITE-718 infusion.

    Measured: Up to 21 days

  2. Phase 1B - Efficacy: Objective Response Rate (ORR)

    ORR is defined as complete response + partial response for participants evaluated by RECIST v1.1 and very good partial response (VGPR) or better for multiple myeloma participants evaluated by International Myeloma Working Group (IMWG) Consensus Panel 1 Criteria.

    Measured: Up to year 2 for solid tumor participants and up to Year 5 for multiple myeloma participants

Secondary outcomes (7)

  1. Duration of Response (DOR)

    For participants who experience an objective response, DOR is defined as the time from the date of their first objective response to the date of disease progression per modified RECIST v1.1 or consensus panel 1 criteria or death regardless of cause.

    Measured: Up to year 2 for solid tumor participants and up to year 5 for multiple myeloma participants

  2. Progression-Free Survival (PFS)

    PFS is defined as the time from the KITE-718 infusion date to the date of disease progression per modified RECIST v1.1 or consensus panel 1 criteria or death from any cause.

    Measured: Up to year 2 for solid tumor participants and up to year 5 for multiple myeloma participants

  3. Overall Survival

    Overall survival is defined as the time from KITE-718 infusion to the date of death.

    Measured: Up to 15 years

  4. Percentage of Participants Experiencing Adverse Events

    Measured: Up to 15 years

  5. Percentage of Participants with Anti-KITE-718 Antibodies

    Measured: Up to 2 years

  6. Percentage of Participants Experiencing Replication-competent Retrovirus (RCR)

    Measured: Up to 2 years

  7. Levels of MAGE-A3/A6 TCR-transduced T Cells in Blood

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2017
  2. Study start27 Dec 2017
  3. Primary completion30 Jun 2021
  4. Study completion4 Jun 2023

Why it stopped: The study was terminated due to the sponsor's decision to discontinue the clinical trial.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03139370
Sponsor's protocol ID
KITE-718-301
Other IDs
2020-005456-37
Status last verified
Aug 2023
First submitted
26 Apr 2017
Last updated
25 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KITE-718, Cyclophosphamide and Fludarabine in people with Solid Tumor, run by Kite, A Gilead Company at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study was terminated due to the sponsor's decision to discontinue the clinical trial.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1A - Percentage of Participants Experiencing Adverse Events Defined as Dose-Limiting Toxicities (time frame: Up to 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03139370.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.

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