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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
Study Summary
This trial tests a new therapy that uses cells from a donor to treat relapsed/refractory leukemia after an allogeneic transplant.
Who is the study for?
Adults with Acute Myeloid Leukemia that has returned or resisted treatment after a specific type of bone marrow transplant (HLA-matched alloHCT) can join. They must have received the transplant from a donor who matches them on eight key genetic markers and is willing to undergo a procedure for this trial. Patients should be in good physical condition, with their major organs functioning well.Check my eligibility
What is being tested?
The trial is testing VCAR33, which is a new therapy involving T cells (a type of immune cell) engineered to target leukemia cells in patients whose AML has come back or hasn't responded after receiving an HLA-matched alloHCT. It's an early-stage trial to see how safe it is and how well it works.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system attacking normal cells, symptoms at the infusion site, tiredness, fever, chills, breathing difficulties, changes in blood pressure and heart rate. The exact side effects will be monitored closely due to the novel nature of this therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of dose-limiting toxicities
Secondary outcome measures
Incidence of GVHD related to VCAR33
Overall survival post-VCAR33 infusion
Percentage of patients who achieve response
+1 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: Morphologic Disease: Cohort 3Experimental Treatment1 Intervention
VCAR33 Dose Level 3
Group II: Morphologic Disease: Cohort 2Experimental Treatment1 Intervention
VCAR33 Dose Level 2
Group III: Morphologic Disease: Cohort 1Experimental Treatment1 Intervention
VCAR33 Dose Level 1
Group IV: MRD Positive: Cohort 3Experimental Treatment1 Intervention
VCAR33 Dose Level 3
Group V: MRD Positive: Cohort 2Experimental Treatment1 Intervention
VCAR33 Dose Level 2
Group VI: MRD Positive: Cohort 1Experimental Treatment1 Intervention
VCAR33 Dose Level 1
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Who is running the clinical trial?
Vor BiopharmaLead Sponsor
2 Previous Clinical Trials
60 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had more than one allogeneic stem cell transplant.I am 18 years old or older.I had a stem cell transplant from a donor who was not a full match or used umbilical cord blood.I am on strong medication for graft-versus-host disease, except if it's mild and only treated topically.I received a bone marrow transplant from a fully matched donor or was in the VBP101 study.I will be less than 100 days after my stem cell transplant when receiving VCAR33 treatment.I am fully active or can carry out light work.My AML has returned or didn't respond after a stem cell transplant.I do not have active brain or spinal cord disease.
Research Study Groups:
This trial has the following groups:- Group 1: Morphologic Disease: Cohort 1
- Group 2: MRD Positive: Cohort 1
- Group 3: MRD Positive: Cohort 2
- Group 4: Morphologic Disease: Cohort 3
- Group 5: MRD Positive: Cohort 3
- Group 6: Morphologic Disease: Cohort 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you provide the total number of healthcare centers administering this clinical trial?
"The Stanford Cancer Institute in Stanford, Florida; Miami Cancer Institute in Miami, Kansas and The University of Kansas Cancer Center in Fairway Michigan are just some of the 10 participating locations actively involved with this trial."
Answered by AI
Are there any remaining opportunities to join this research project?
"As of now, clinicaltrials.gov does not indicate that participants are being sought for this study which was first listed on October 1st 2023 and last updated on August 1st 2023. However, there are 1466 other medical trials available with openings at the present moment."
Answered by AI
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