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CAR T-cell Therapy

Fludarabine for Biphenotypic Leukemia

Phase 1
Waitlist Available
Led By Elizabeth Krakow
Research Sponsored by Fred Hutchinson Cancer Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Summary

This trial is testing a new immunotherapy for leukemia that uses T cells that have been genetically modified to target a protein found on the surface of leukemia cells.

Eligible Conditions
  • Biphenotypic Leukemia
  • Chronic Myelogenous Leukemia
  • Myelodysplastic Syndrome
  • Myelomonocytic Leukemia
  • Acute Lymphoblastic Leukemia
  • Myelodysplastic Syndromes
  • Blastic Plasmacytoid Dendritic Cell Neoplasm
  • Acute Leukemia
  • Leukemia
  • Acute Myeloid Leukemia
  • Chronic Myelomonocytic Leukemia
  • Undifferentiated Leukemia
  • Acute Undifferentiated Leukemia
  • Minimal Residual Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of administering minor H antigen (HA-1) T cell receptor (TCR) CD8+ and CD4+ T cells
Feasibility of manufacturing minor H antigen (HA-1) T cell receptor (TCR) CD8+ and CD4+ T cells
Incidence of dose-limiting toxicities of HA-1 T cell receptor (TCR) T cells
Secondary outcome measures
Duration of in vivo persistence of transferred HA-1 T cell receptor (TCR) CD4+ T cells in peripheral blood
Duration of in vivo persistence of transferred HA-1 T cell receptor (TCR) CD8+ T cells in peripheral blood
Presence, proportion and persistence of HA-1 T cell receptor (TCR) CD4+ T cells in the bone marrow
+6 more

Side effects data

From 2021 Phase 3 trial • 30 Patients • NCT01877837
36%
Infection (grade 3 and above)
24%
Graft versus host disease
8%
Renal insufficiency
4%
SupraVentricular Tachycardia
4%
Alerted mental status
4%
Posterior Reversible Encephalopathy Syndrome
4%
Gastrointestinal bleed
4%
Respiratory failure
4%
Hypokalemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Patients With Sickle Cell Anemia

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (CD4+ and CD8+ HA-1 TCR T cells)Experimental Treatment3 Interventions
Patients receive fludarabine for 1-3 doses 3-14 days prior to HA-1 TCR T cell administration. Patients then receive CD4+ and CD8+ HA-1 TCR T cells IV over 1 hour.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1020

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,305 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
558 Previous Clinical Trials
1,345,561 Total Patients Enrolled
HighPass Bio, Inc.UNKNOWN
~8 spots leftby Oct 2027
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