FH-FOLR1 Chimeric Antigen Receptor T Cell Therapy for Treating Pediatric Patients With Relapsed or Refractory Acute Myeloid Leukemia
Recruiting
Phase 1
Interventional Study
Recurrent Childhood Acute Myeloid Leukemia
Refractory Childhood Acute Myeloid Leukemia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- Up to 6
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 12 (estimated)
- Sponsor
- Fred Hutchinson Cancer Center · Other
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About This Trial
This phase I trial tests the safety, side effects, and best dose of FH-FOLR1 chimeric antigen receptor (CAR) T cells in treating pediatric patients with FOLR1+ acute myeloid leukemia (AML) that has come back after a period of improvement (recurrent) or has not responded to previous treatment (refractory). CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune syst…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Subject age ≤ 6 years.
* Weight ≥ 7 kilograms.
* AML that expresses FOLR1 by flow cytometry as assessed by Hematologics, Inc.
Laboratory and meets one of the below definitions:
* For subjects who have previously received an allogeneic hematopoietic cell transplantation (HCT)…
Contacts