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CAR T-cell Therapy
CD33 CART Therapy for Acute Myeloid Leukemia
Phase 1 & 2
Recruiting
Led By Nirali Shah, MD, MHSc
Research Sponsored by Center for International Blood and Marrow Transplant Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects in second or greater relapse will be eligible with relapse defined as >5% blasts (bone marrow) after second documented complete remission
Patients with two prior allogenic donor stem cell transplants must be medically fit for a third allogenic donor stem cell transplant
Must not have
Intrathecal chemotherapy ≥ 3 days
CAR T-cell therapy: Excluded unless at least 30 days from prior CAR T-cell infusion and without detectable circulating CAR T-cells
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days post cd33cart infusion
Awards & highlights
No Placebo-Only Group
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.
Who is the study for?
This trial is for children and young adults aged 1-35 with relapsed/refractory acute myeloid leukemia (AML) that expresses CD33. Participants must have had at least one failed treatment, be eligible for a stem cell transplant, and have adequate organ function. Pregnant or breastfeeding individuals, those with certain infections or other cancers, and anyone who has recently received specific treatments are excluded.
What is being tested?
The study tests two types of anti-CD33 CAR T-cell therapies: autologous (from the patient's own cells) and allogeneic (donor cells). It aims to find the highest dose patients can tolerate without severe side effects in Phase 1 and then assess how well the treatment works in Phase 2.
What are the potential side effects?
Potential side effects may include immune reactions leading to inflammation in various organs, symptoms related to infusion such as fever or chills, fatigue, blood count abnormalities which could increase infection risk, allergic reactions to components used in cell manufacturing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has returned after a second complete remission, with more than 5% cancer cells in my bone marrow.
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I am medically fit for a third stem cell transplant from a donor.
Select...
My heart pumps well, with an ejection fraction of 45% or more.
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I can do most activities, but may need help, or I use a wheelchair but am not bedridden.
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My kidney function is within the normal range for my age.
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My AML has relapsed twice or more, or after a transplant, or is resistant to chemotherapy.
Select...
My leukemia didn't respond to initial or re-induction chemotherapy.
Select...
More than half of my cancer cells show CD33 expression.
Select...
I have a donor for a stem cell transplant planned within 1.5 to 2 months after receiving a specific cell therapy.
Select...
My leukemia has returned after a transplant and tests show at least 0.1% of my cancer cells are CD33+.
Select...
I am between 1 and 35 years old.
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My oxygen levels are above 92% without assistance.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had chemotherapy injected into my spine more than 3 days ago.
Select...
It's been over 30 days since my last CAR T-cell therapy and I have no detectable CAR T-cells.
Select...
I received a donor lymphocyte infusion within the last 30 days.
Select...
I do not have HIV, HBV, or HCV infections.
Select...
I have or had CNS leukemia but it's now treated.
Select...
I am not on steroid therapy, or only take low-dose steroids for adrenal insufficiency.
Select...
I am currently on immunosuppressive medication for active GVHD.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days post cd33cart infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days post cd33cart infusion
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum tolerated dose - Allogeneic Arm
Maximum tolerated dose - Autologous Arm
Secondary study objectives
Allogeneic hematopoietic stem cell transplantation
Feasibility of CD33CART infusion
Feasibility of CD33CART manufacture
+8 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: CD33CART autologousExperimental Treatment1 Intervention
Patients who receive an autologous CD33CART cell infusion
Group II: CD33 CART allogeneicExperimental Treatment1 Intervention
Patients who receive an allogeneic CD33CART cell infusion
Find a Location
Who is running the clinical trial?
Center for International Blood and Marrow Transplant ResearchLead Sponsor
38 Previous Clinical Trials
200,193,378 Total Patients Enrolled
National Marrow Donor ProgramOTHER
60 Previous Clinical Trials
202,508 Total Patients Enrolled
St. Baldrick's FoundationOTHER
18 Previous Clinical Trials
9,086 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: CD33CART autologous
- Group 2: CD33 CART allogeneic
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.
Acute Myeloid Leukemia Patient Testimony for trial: Trial Name: NCT03971799 — Phase 1 & 2
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