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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 12 and 24
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
Select...
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of neutrophil engraftment
Secondary outcome measures
Incidence of acute GVHD Grade (G) G2-G4 and G3-G4
Incidence of chronic GVHD (all and moderate-severe)
Incidence of primary and secondary graft failure
+7 more

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

Frequently Asked Questions

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

Will elderly patients be accepted into this clinical research program?

"As this is a clinical trial, the age limit for participants is 18-70."

Answered by AI

How many different medical clinics are conducting this study?

"This trial has 9 enrolment sites, which include the University of California San Diego Moores Cancer Center in La Jolla, National Institutes of Health Clinical Center in Bethesda, and Fred Hutchinson Cancer Research Center in Seattle. There are also 6 other locations where patients can be enrolled."

Answered by AI

Who meets the requirements to join this clinical trial?

"Eligibility requirements for this clinical trial include a diagnosis of acute myeloid leukemia, being between 18-70 years old. To date, the study has recruited 18 people in total."

Answered by AI

Is this research looking for more participants?

"The clinical trial is still recruiting patients, as reflected on the clinicaltrials.gov website. The study was originally posted on 8/31/2021 and has since been updated on 9/28/2022."

Answered by AI

How many people are being enrolled in this clinical trial?

"That is correct, the clinicaltrials.gov website has information stating that this trial is looking for more participants. This study was originally posted on August 31st, 2021 and updated September 28th, 2022. There are a total of 18 patients needed to be enrolled from 9 different locations."

Answered by AI

What other research studies have included VOR33 as a variable?

"VOR33 was first researched in 2007 by M D Anderson Cancer Center. So far, there have been 26 completed trials. Right now, 27 studies are actively recruiting patients with a majority of these taking place in La Jolla, California."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Allogeneic Engineered Hematopoietic Stem Cell Transplant (HCT) Lacking the CD33 Protein, and Post-HCT Treatment With Mylotarg, for Patients With CD33+ AML or MDS
2021. "Allogeneic Engineered Hematopoietic Stem Cell Transplant (HCT) Lacking the CD33 Protein, and Post-HCT Treatment With Mylotarg, for Patients With CD33+ AML or MDS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04849910.
All > Acute Myeloid Leukemia > Myelodysplastic Syndrome
~6 spots leftby Feb 2025
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