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CAR T-cell Therapy

KITE-222 for Acute Myeloid Leukemia

Phase 1
Waitlist Available
Research Sponsored by Kite, A Gilead Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prior exposure to the relevant agent class for individuals with AML characterized by a mutation targeted by an approved therapy
- Cardiac ejection fraction ≥ 50%, no clinically significant pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first infusion date of kite-222 up to 15 years
Awards & highlights

Study Summary

This trial is testing a new drug, KITE-222, to see if it is safe and effective in treating people with a certain type of leukemia.

Who is the study for?
This trial is for adults with relapsed/refractory acute myeloid leukemia (AML) who have good heart, liver, kidney, and lung function. They should not have had certain severe heart conditions or other cancers in the past 3 years. Participants must be fit for a stem-cell transplant and agree to use contraception.Check my eligibility
What is being tested?
The study tests KITE-222's safety and proper dosing in AML patients who've seen their cancer return or resist treatment. It involves pre-treatment with Cyclophosphamide and Fludarabine followed by KITE-222 therapy.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as fever, fatigue, infusion-related reactions; organ inflammation; blood cell count changes; increased risk of infections due to weakened immunity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have AML with a specific mutation and have been treated with a targeted therapy before.
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My heart pumps well, and I have no serious heart fluid buildup or ECG issues.
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My kidneys are functioning well, with a creatinine clearance rate of 60 mL/min or higher.
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I am fully active or can carry out light work.
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My oxygen levels are above 92% without assistance and I don't have serious fluid in my lungs.
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I meet the requirements for a stem cell transplant and have a donor ready.
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My AML has returned or didn't respond to treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first infusion date of kite-222 up to 15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and first infusion date of kite-222 up to 15 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)
Secondary outcome measures
30 Day All-cause Mortality Rate
60 Day All-cause Mortality Rate
Allogeneic Stem Cell Transplant (allo-SCT) Rate
+14 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: KITE-222Experimental Treatment3 Interventions
Dose Escalation: Participants will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single target starting dose of KITE-222 chimeric antigen receptor (CAR) transduced autologous T cells. Based on dose limiting toxicities (DLTs) observed in the first cohort, additional participants will be enrolled and administered escalating dose of KITE-222 to determine the maximum tolerated dose (MTD) of KITE-222. Dose Expansion: Participants will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single dose (at the MTD determined) of KITE-222.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Fludarabine
2012
Completed Phase 3
~1100

Find a Location

Who is running the clinical trial?

Kite, A Gilead CompanyLead Sponsor
43 Previous Clinical Trials
3,616 Total Patients Enrolled
Gilead SciencesLead Sponsor
1,084 Previous Clinical Trials
848,439 Total Patients Enrolled
Kite Study DirectorStudy DirectorKite, A Gilead Company
28 Previous Clinical Trials
2,974 Total Patients Enrolled

Media Library

KITE-222 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04789408 — Phase 1
Acute Myeloid Leukemia Clinical Trial 2023: KITE-222 Highlights & Side Effects. Trial Name: NCT04789408 — Phase 1
KITE-222 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04789408 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other investigations into the effects of KITE-222?

"KITE-222 was initially studied at City of Hope Comprehensive Cancer Center back in 1997. To date, 1275 trials have been completed and 889 are presently underway; many of which take place in Houston, Texas."

Answered by AI

What is the size of the cohort involved in this clinical research?

"In order to conduct this research trial, Gilead Sciences must recruit 40 prospective patients who meet the requirements listed in their inclusion criteria. These medical professionals are based out of The University of Texas MD Anderson Cancer Center in Houston and The Ohio State University Wexner Medical Center/James Cancer Hospital in Columbus."

Answered by AI

Is there currently an enrollment period for this clinical experiment?

"The research posted to clinicaltrials.gov is still actively seeking participants, with the initial submission occurring on July 19th 2021 and most recent update made October 10th 2022."

Answered by AI

What therapeutic purpose is KITE-222 most commonly employed for?

"KITE-222 is frequently prescribed to manage multiple sclerosis, but it can also be employed as an intervention against various other cancers such as mixed-cell type lymphoma and acute myelocytic leukemia. Additionally, this drug has been known to help treat retinoblastoma."

Answered by AI

How perilous is KITE-222 for those undergoing treatment?

"Based on the limited evidence of its efficacy and safety, this Phase 1 trial has been given a score of one by our team at Power."

Answered by AI

What is the magnitude of facilities overseeing this trial?

"The University of Texas MD Anderson Cancer Center, The Ohio State University Wexner Medical Center/James Cancer Hospital, and Stanford Cancer Center constitute the main sites for this trial. Additionally, seven other medical centres are involved in its operation."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of KITE-222 in Participants With Relapsed/Refractory Acute Myeloid Leukemia
2021. "Study of KITE-222 in Participants With Relapsed/Refractory Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04789408.
~16 spots leftby Feb 2026
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