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CAR T-cell Therapy
CAR T-Cell Therapy for Acute Myeloid Leukemia
Phase 1
Recruiting
Led By Karamjeet S Sandhu
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years post study treatment
Awards & highlights
Study Summary
This trial tests a new CAR T-cell therapy to treat leukemia that has come back or doesn't respond to treatment.
Who is the study for?
Adults with acute myeloid leukemia (AML) that has returned or is unresponsive to treatment, who have a life expectancy of at least 16 weeks and are in relatively good health as indicated by certain organ function tests. Participants must not be pregnant, agree to use birth control, and have a potential stem cell donor. Those with active autoimmune diseases, other cancers, significant heart issues within the past 6 months, or infections like HIV or hepatitis are excluded.Check my eligibility
What is being tested?
The trial is testing anti-CD33 CAR T-cell therapy for AML patients whose cancer has either come back after treatment or hasn't responded at all. The therapy involves modifying immune cells to target cancer cells more effectively. It's in phase I to determine safety and optimal dosing.See study design
What are the potential side effects?
Potential side effects may include reactions related to the infusion of modified T-cells such as fever and chills, fatigue, risk of infection due to immune system suppression from lymphodepletion therapy prior to T-cell infusion, possible autoimmune responses against normal cells bearing CD33 protein.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 15 years post study treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 years post study treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of dose-limiting toxicities and full toxicity profile
Participants who achieve measurable residual disease (MRD)
Secondary outcome measures
Duration of response
Expansion and persistence of the CAR T cell product
Overall survival
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (anti-CD33 CAR T-cells)Experimental Treatment2 Interventions
Patients undergo lymphodepletion therapy 3-5 days prior to CAR T cell infusion and receive anti-CD33 CAR T-cells IV on day 0. Patients with persistent CD33+ AML who are > 28 days past the initial CAR T infusion, have additional product available and did not experience a dose-limiting toxicity, may optionally receive anti-CD33 CAR T-cells IV.
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Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,414 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
567 Previous Clinical Trials
1,922,633 Total Patients Enrolled
Karamjeet S SandhuPrincipal InvestigatorCity of Hope Medical Center
2 Previous Clinical Trials
50 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has been confirmed to be CD33 positive within the last 3 months.My heart rhythm problem is not stable, even with medication, and I'm about to undergo leukapheresis.I am not pregnant or breastfeeding.I am 18 years old or older.I am able to care for myself but may not be able to do active work.I had a transplant from another person more than 6 months ago.My donor does not have HIV.As a donor, I am mostly able to care for myself.I have not taken antifungal medication in the last 8 weeks.I have a bleeding disorder like von Willebrand's disease or hemophilia.I have not had a stroke or brain bleed in the last 6 months.I am currently taking antibiotics for an infection.My kidneys work well and I am not on dialysis.I have a donor for a stem cell transplant that matches me closely.I know my current body weight.I do not have any uncontrolled serious illnesses.My heart pumps well, with an ejection fraction of 50% or higher.I can provide bone marrow or blood samples for AML diagnosis confirmation.I am a woman who can have children and my pregnancy test is negative.My stem cell donor is the same person who donated to me before.I have been diagnosed with a type of leukemia that is either new or has come back.I stopped taking steroids or immunosuppressants 28 days before joining.My oxygen levels are above 92% without needing extra oxygen.I stopped my autoimmune treatment 28 days before joining.I have no active cancer except for my current diagnosis, or any past cancer has been successfully treated.I have active viral hepatitis.My bone marrow biopsy shows I have Grade 2 or higher myelofibrosis.I am not currently on any experimental drugs or dependent on ongoing cancer treatments.I had a transplant from another person less than 6 months ago.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (anti-CD33 CAR T-cells)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential risks are associated with Treatment (anti-CD33 CAR T-cells) for human health?
"As this is an early-stage trial, the safety of Treatment (anti-CD33 CAR T-cells) was rated a 1 due to limited data existing on its efficacy and security."
Answered by AI
Are there any opportunities to volunteer for the trial currently available?
"Per information found on clinicaltrials.gov, this study is not presently seeking participants; it was first posted in May 13th 2023 and last edited three months later on January 3rd 2023. Even so, there are currently 1,498 other trials recruiting patients as of now."
Answered by AI
What aims are investigators hoping to accomplish with this medical experiment?
"The primary goal of this long-term trial is to measure the incidence and severity of dose-limiting adverse effects. Secondary objectives include quantifying peripheral blood cell subsets within hematopoietic stem/progenitor compartments, tracking duration of response for participants who reach complete remission (CR), and assessing progression-free survival for those enrolled in the study."
Answered by AI
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