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Ex Vivo T-cell receptor alpha-beta and CD19+ Depletion
Stem Cell Transplant for Blood Cancer
Phase 1
Recruiting
Led By Sima Bhatt, M.D., MSCI
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Recipient must have Lansky or Karnofsky performance status > 50%
Recipient must have adequate organ function including cardiac, hepatic, renal, and pulmonary functions as defined
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over 24 months
Awards & highlights
Study Summary
This trial is designed to study the safety and efficacy of a new stem cell transplantation technique using cells from a familial donor who is not a perfect match.
Who is the study for?
This trial is for children and young adults up to 30 years old with certain high-risk blood cancers or tumors who have a family member that can be a half-matched stem cell donor. They must have good heart, lung, liver, and kidney function and agree to use birth control if they can have children. Patients with uncontrolled illnesses, active infections, or those pregnant cannot join.Check my eligibility
What is being tested?
The study tests a new way of preparing donated stem cells from family members before transplanting them into patients. It involves removing specific immune cells (αβ-TCR+ T-cells and CD19+ B-cells) which may help reduce complications after the transplant.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system as it rebuilds (like graft-versus-host disease), infection risks due to weakened immunity post-transplantation, and typical transplantation-related side effects such as fatigue or nausea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can do most activities but need help with some.
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My heart, liver, kidneys, and lungs are all working well.
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I am 30 years old or younger.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 2 years post transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 2 years post transplant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Donor cell chimerism as measured by short tandem repeat analysis
Engraftment as measured by time to neutrophil count recovery
Engraftment as measured by time to platelet count recovery
+1 moreSecondary outcome measures
Change in Lansky/Karnofsky performance score
Event free survival (EFS)
Immune reconstitution as measured by recovery of absolute monocyte count
+17 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: ex vivo αβ-TCR/CD19 depleted haplo-hematopoietic stem cell infusion (HSCT)Experimental Treatment1 Intervention
Patients will undergo standard of care conditioning regiment prior to HSCT
On Day 0, patients will undergo infusion of the ex vivo αβ-TCR/CD19 depleted haplo-HSCT from a stimulated peripheral stem cell source per institutional standard of care. Patients whose graft has a residual CD20+ count > 1.0 x 10^5 may receive a single infusion of rituximab on Day +1 at a dose of 375 mg/m^2 at provider's discretion.
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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,935 Previous Clinical Trials
2,299,774 Total Patients Enrolled
Sima Bhatt, M.D., MSCIPrincipal InvestigatorWashington University School of Medicine
Jeffrey Bednarski, M.D., Ph.D.Principal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can do most activities but need help with some.I do not have cancer that has spread to my brain or outside the bone marrow.I have a specific type of leukemia or myelodysplastic syndrome in a certain stage.My heart, liver, kidneys, and lungs are all working well.I do not have any untreated or uncontrolled illnesses.I do not have any active cancer other than in my blood.I am at least 6 months old.I don't have strong immune reactions against donor tissues.I can understand and sign a consent form.I can understand and sign a consent form.I am 30 years old or younger.
Research Study Groups:
This trial has the following groups:- Group 1: ex vivo αβ-TCR/CD19 depleted haplo-hematopoietic stem cell infusion (HSCT)
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.
Are there any available slots to join this experiment?
"This clinical trial is actively recruiting patients, as evidenced by its listing on the website of clinicaltrials.gov. The posting was initially uploaded on November 3rd 2022 and recently modified on November 4th 2022."
Answered by AI
Is αβ-TCR/CD19 cell depleted haploidentical hematopoietic stem cell graft a safe option for individuals?
"Our team at Power adjudged the security of αβ-TCR/CD19 cell depleted haploidentical hematopoietic stem cell graft a 1, due to limited clinical data indicating its efficacy and safety."
Answered by AI
How many participants are there in this research endeavor?
"Affirmative. According to clinicaltrials.gov, the trial is actively enlisting participants as of now and was initially published on November 3rd 2022 before being amended on November 4th 2022. 32 people need to be enrolled from 1 medical facility for this experiment."
Answered by AI
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