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CD33 CART Therapy for Acute Myeloid Leukemia
Study Summary
This trial is testing a new treatment for leukemia that uses the patient's own immune cells. The first part of the trial will test how safe it is, and the second part will test how well it works.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- My liver is working well.My cancer has returned after a second complete remission, with more than 5% cancer cells in my bone marrow.I have taken hydroxyurea for 1 day.My bilirubin levels are within normal limits, or I have Gilbert's disease.I have had chemotherapy injected into my spine more than 3 days ago.I am medically fit for a third stem cell transplant from a donor.My heart pumps well, with an ejection fraction of 45% or more.I haven't taken any experimental cancer drugs in the last 28 days.My blood cancer is CD33+ and might improve with a specific therapy.I can do most activities, but may need help, or I use a wheelchair but am not bedridden.My organs are functioning well.My kidney function is within the normal range for my age.My AML has relapsed twice or more, or after a transplant, or is resistant to chemotherapy.I have waited 3 half-lives since my last checkpoint inhibitor or antibody therapy.It's been over 30 days since my last CAR T-cell therapy and I have no detectable CAR T-cells.You have a very high number of cancer cells in your blood or your disease is progressing very quickly, which may make it difficult for you to complete the treatment in the study.I haven't taken azacytidine, decitabine, or venetoclax in the last 7 days.You have received a type of stem cell transplant called allogeneic stem cell transplant in the past.You have had a serious allergic reaction in the past to similar medicines or substances used in the study.I am currently on a milder form of chemotherapy to control my disease.I am over 18 and can make my own health decisions or have a guardian who can.My leukemia didn't respond to initial or re-induction chemotherapy.More than half of my cancer cells show CD33 expression.I have a donor for a stem cell transplant planned within 1.5 to 2 months after receiving a specific cell therapy.You are currently breastfeeding.I haven't had chemotherapy in the last 14 days.I have followed the required medication break before my apheresis procedure.It has been over 42 days since my last clofarabine or nitrosureas treatment.I received a donor lymphocyte infusion within the last 30 days.I do not have HIV, HBV, or HCV infections.I have not taken immunosuppressants for GVHD prevention in the last 30 days.I do not have an active second cancer.I have a non-invasive cervical cancer.I am in remission from another type of cancer.My disease status matches the trial's requirements at sign-up.My leukemia has returned after a transplant and tests show at least 0.1% of my cancer cells are CD33+.I am between 1 and 35 years old.My oxygen levels are above 92% without assistance.I have or had CNS leukemia but it's now treated.I am willing to use birth control during and for four months after treatment.I have recently undergone treatment.I stopped taking tyrosine kinase inhibitors at least 7 days ago.I am not on steroid therapy, or only take low-dose steroids for adrenal insufficiency.I finished my radiation therapy at least 3 weeks ago, or it treated less than 10% of my bone marrow.I am currently on immunosuppressive medication for active GVHD.I am HIV positive.I do not have any active or uncontrolled infections.
- Group 1: CD33CART autologous
- Group 2: CD33 CART allogeneic
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What are we hoping to learn from this research?
"The primary outcome of interest for this clinical trial is the maximum tolerated dose, which will be evaluated over a 28 day period post-CD33CART infusion. Additionally, secondary outcomes including feasibility of CD33CART infusion (defined as number of subjects able to proceed to infusion 6 weeks post apheresis), allogeneic hematopoietic stem cell transplantation (defined as percentage of subjects able to proceed to allogeneic hematopoietic stem cell transplant following treatment with CD33CART), and progression free survival (measured from infusion of CD33CART cells until documentation of disease progression or death due"
How many individuals are being monitored in this experiment?
"37 individuals that meet the pre-determined medical requirements are necessary for this clinical trial to commence. These participants can be recruited from various hospitals, including The Children's Hospital of Philadelphia and Dana-Farber Cancer Institute."
Are patients being actively recruited for this trial at this time?
"The clinical trial is still recruiting patients, according to the most recent information on clinicaltrials.gov. This study was originally posted on 1/8/2020 and has been edited recently on 5/10/2022. The researchers are looking for 37 more participants that will be recruited from 6 different sites."
Who can join this clinical trial and what are the requirements?
"This study is accepting 37 people, within the ages of 1 Year and 35 who have leukemia, myelocytic, acute. It is important that patients also meet the following criteria: Subjects in second or greater relapse will be eligible with relapse defined as >5% blasts (bone marrow) after second documented complete remission, Any degree of detectable disease post-transplant relapse will be eligible (with flow cytometric confirmation of CD33+ myeloid leukemia of at least 0.1%), CD33 expression must be detected on greater than 50% of the malignant cells by immunohistochemistry or greater than 80% by flow"
Does this research involve test subjects that are elderly?
"The age bracket for people that this trial is recruiting is 1-35 years old."
How many different medical facilities are managing this trial today?
"Presently, this trial is taking place in 6 different medical facilities. These locations include Philadelphia, Boston, and Aurora. If you are interested in participating in this study, please choose the location nearest to you so that travel isn't a burden."
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