CD33CART for Acute Myeloid Leukemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Acute Myeloid LeukemiaCD33CART - Biological
Eligibility
1 - 35
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Acute Myeloid Leukemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 9 Secondary · Reporting Duration: I year post HCT

1 year post HCT
Overall survival
Week 2
Feasibility of CD33CART manufacture
Week 6
Allogeneic hematopoietic stem cell transplantation
6 weeks post apheresis
Feasibility of CD33CART infusion
Week 8
Cytokine release syndrome (CRS), sinusoidal occlusion syndrome (SOS), or other CD33CART related toxicities
Day 28
Maximum tolerated dose
Molecular remission
Morphologic remission
Day 42 post HCT
Post HCT time to engraftment
I year post HCT
Progression free survival
Treatment related mortality

Trial Safety

Trial Design

1 Treatment Group

CD33CART
1 of 1

Experimental Treatment

37 Total Participants · 1 Treatment Group

Primary Treatment: CD33CART · No Placebo Group · Phase 1 & 2

CD33CART
Biological
Experimental Group · 1 Intervention: CD33CART · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: i year post hct

Who is running the clinical trial?

St. Baldrick's FoundationOTHER
18 Previous Clinical Trials
9,007 Total Patients Enrolled
National Marrow Donor ProgramOTHER
59 Previous Clinical Trials
182,546 Total Patients Enrolled
Center for International Blood and Marrow Transplant ResearchLead Sponsor
34 Previous Clinical Trials
200,173,941 Total Patients Enrolled
Richard Aplenc, MD, PhDPrincipal InvestigatorChildren's Hospital of Philadelphia
3 Previous Clinical Trials
850 Total Patients Enrolled
Nirali Shah, MD, MHScPrincipal InvestigatorNational Cancer Institute (NCI)

Eligibility Criteria

Age 1 - 35 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Subjects must have CD33+ AML in second or greater relapse, post-transplant relapse, or have demonstrated chemotherapy-refractory disease (definitions in criteria 2c) to be eligible to participate in this trial.
You have persistent bone marrow involvement with >5% blasts after two courses of induction chemotherapy for patients at initial presentation or >5% bone marrow blasts after one course of re-induction chemotherapy for patients in relapse.
You are medically fit for a third allogenic donor stem cell transplant.