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CAR T-cell Therapy

Stem Cell Transplant + Mylotarg for Acute Myeloid Leukemia

Phase 1 & 2
Recruiting
Research Sponsored by Vor Biopharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have adequate performance status and organ function as defined below: Performance Status: Karnofsky score of ≥70, Cardiac: left ventricular ejection fraction (LVEF) ≥50%, Pulmonary: diffusing capacity of lung for carbon monoxide (DLCO), forced vital capacity (FVC), and forced expiratory volume in one second (FEV1) ≥66%, Renal: estimated glomerular filtration rate (GFR) >60 mL/min, Hepatic: total bilirubin <1.5 × ULN, or if ≥1.5 × ULN direct bilirubin <ULN and ALT/AST <1.5 × ULN (per institutional criteria)
Candidate for HLA-matched allogeneic HCT using a myeloablative conditioning regimen
Must not have
Prior treatment with Mylotarg™ (gemtuzumab ozogamicin)
Active central nervous system (CNS) leukemia or history of other active malignancy(ies)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 12 and 24
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug, VOR33, on people with AML who are having a HCT.

Who is the study for?
This trial is for adults aged 18-70 with CD33+ AML who are candidates for a stem cell transplant from a perfectly matched donor. They should be in remission or have low blast counts, unless approved by the medical monitor. Participants need good heart, lung, kidney, and liver function but can't join if they've had certain other cancers, prior Mylotarg treatment, specific genetic abnormalities related to leukemia, or uncontrolled infections.
What is being tested?
The study tests VOR33-engineered stem cells lacking CD33 protein followed by Mylotarg post-transplant in patients with AML. It's an early-phase trial to see how safe it is and how well it works when given during a standard HLA-matched allogeneic hematopoietic cell transplant.
What are the potential side effects?
Potential side effects include those typical of stem cell transplants such as infection risk due to immune suppression and reactions related to graft-versus-host disease. Mylotarg may cause liver problems (including severe), infusion-related reactions, bleeding issues, and could potentially harm normal blood-forming cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am eligible for a stem cell transplant from a donor with matching tissue type.
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I am between 18 and 70 years old.
Select...
My AML cancer cells show CD33 presence.
Select...
I have a stem cell donor who is a perfect match for me.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with Mylotarg™ before.
Select...
I do not have active brain leukemia or any other active cancer.
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I have been diagnosed with Gilbert's syndrome.
Select...
I do not have uncontrolled infections or known HIV, Hepatitis B, or C.
Select...
My leukemia has specific genetic markers.
Select...
I have had a stem cell transplant before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 12 and 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and months 12 and 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of neutrophil engraftment
Secondary study objectives
Incidence of primary and secondary graft failure
Overall Survival (OS)
Percentage of CD33-negative myeloid cells
+3 more

Awards & Highlights

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

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment2 Interventions
VOR33 infusion followed by Mylotarg Dose Level 3
Group II: Cohort 2Experimental Treatment2 Interventions
VOR33 infusion followed by Mylotarg Dose Level 2
Group III: Cohort 1Experimental Treatment2 Interventions
VOR33 infusion followed by Mylotarg Dose Level 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mylotarg
2006
Completed Phase 2
~120

Find a Location

Who is running the clinical trial?

Vor BiopharmaLead Sponsor
2 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

VOR33 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04849910 — Phase 1 & 2
Acute Myeloid Leukemia Research Study Groups: Cohort 1, Cohort 2, Cohort 3
Acute Myeloid Leukemia Clinical Trial 2023: VOR33 Highlights & Side Effects. Trial Name: NCT04849910 — Phase 1 & 2
VOR33 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04849910 — Phase 1 & 2
~1 spots leftby Feb 2025
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