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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
Patients must express HLA-A*0201
Myelodysplastic syndrome (MDS) of any subtype
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study 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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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
~1100

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,221 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
556 Previous Clinical Trials
1,343,192 Total Patients Enrolled
HighPass Bio, Inc.UNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum participant count for this experiment?

"Affirmative. Clinicaltrials.gov information confirms that the trial, which was first uploaded on February 23rd 2018, is actively recruiting patients at a single site and searching for 24 volunteers overall."

Answered by AI

Is the research endeavor currently admitting new participants?

"According to clinicaltrials.gov, this trial is open for enrollment and has been so since its initial posting on February 23rd 2018 with the most recent update occurring on September 7th 2022."

Answered by AI

What goals is this clinical trial striving to achieve?

"This clinical trial will measure the efficacy of administering minor H antigen (HA-1) T cell receptor (TCR) CD8+ and CD4+ T cells over a given time frame. Secondary objectives include assessing the presence, proportion, and persistence of HA-1 TCRs in bone marrow via tetramer or qPCR testing; measuring how long these receptors stay in peripheral blood; as well as determining what percentage of participants develop symptoms or signs related to graft versus host disease through standard GVHD grading criteria."

Answered by AI

Has the Food and Drug Administration green-lit Fludarabine for public use?

"Fludarabine is still in the early stages of development, so its safety was provisionally given a score of 1. Currently, there is limited data on both efficacy and safety for this medication."

Answered by AI

Are there any other precedents of Fludarabine being used in medical research?

"As of the present, 369 trials are underway investigating Fludarabine. Of these active studies, 22 have progressed to Phase 3. Boston Massachusetts holds the most concentration of such clinical research though there are 3764 sites across America conducting related investigations."

Answered by AI
~9 spots leftby Oct 2027