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CAR T-cell Therapy

Modified Stem Cell Transplant + CAR T Cells for Acute Myeloid Leukemia (CART33 Trial)

Phase 1
Recruiting
Led By Noelle Frey, MD
Research Sponsored by University of Pennsylvania
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 15 years
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test a new treatment for Acute Myeloid Leukemia (AML). The treatment involves a combination of a modified stem cell transplant from a healthy donor and CAR T cells that

Who is the study for?
This trial is for adults over 18 with Acute Myeloid Leukemia (AML) that's hard to cure with existing treatments. Candidates must have a suitable stem cell donor, good kidney and liver function, no severe heart or lung issues, and can't be on systemic immunosuppression if they've had a transplant before.
What is being tested?
The study tests a new AML treatment combining modified stem cell transplants from donors with CAR T-cell therapy. The CAR T-cells are designed to target leukemia cells without affecting the newly transplanted 'invisible' healthy blood cells.
What are the potential side effects?
Potential side effects may include reactions at the infusion site, flu-like symptoms, changes in blood pressure or heart rate, difficulty breathing, fatigue, fever, chills and risk of infection due to immune system suppression.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Manufacturing feasibility
Occurrence of dose-limiting toxicities related to CART-33
Occurrence of dose-limiting toxicities related to CD33KO-HSPC
Secondary study objectives
Duration of Response (DOR)
Efficacy of CD33KO-HSPC
Efficacy of at least 1 dose of CART-33
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: CD33KO-HSPC followed by CART33Experimental Treatment1 Intervention
All subjects will receive CD33KO-HSPC, followed by 1-3 CART-33 infusions

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,079 Previous Clinical Trials
42,721,383 Total Patients Enrolled
Noelle Frey, MDPrincipal InvestigatorUniversity of Pennsylvania
10 Previous Clinical Trials
210 Total Patients Enrolled
David Porter, MDPrincipal InvestigatorUniversity of Pennsylvania
6 Previous Clinical Trials
111 Total Patients Enrolled
~11 spots leftby Feb 2029
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