Your session is about to expire
← Back to Search
Stem Cell Transplant
Stem Cell Transplant with T-allo10 Addback for Blood Diseases
Phase 1
Recruiting
Led By Alice Bertaina, MD, PhD
Research Sponsored by Porteus, Matthew, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age > 1 months (with minimum weight of 10 Kg) and < 45 years.
Patient already received αβdepleted-HSCT and has myeloid engraftment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through day 60 (+/- 10 days) after infusion of t-allo10
Awards & highlights
Study Summary
This trial is studying a cell therapy called T-allo10 given after a stem cell transplant in order to help with the adaptive immune reconstitution while sparing the risk of developing severe Graft-versus-Host Disease.
Who is the study for?
This trial is for children and adults aged over 1 month and under 45 years with life-threatening blood diseases, who've had a specific type of stem cell transplant (αβdepleted-HSCT) and are part of another study (NCT04249830). They must not have severe Graft-versus-Host Disease or be pregnant. Participants need to give consent personally or through a legal representative.Check my eligibility
What is being tested?
The trial tests the safety of T-allo10 cells after an αβdepleted-HSCT in patients with hematologic malignancies. It aims to find the right dose that boosts immune recovery while minimizing severe GvHD risk. The study includes two phases: determining the optimal dose and then assessing its safety and effectiveness.See study design
What are the potential side effects?
Potential side effects may include reactions related to stem cell transplantation like infection risks, possible development of mild to severe Graft-versus-Host Disease, infusion-related reactions, and complications from weakened immunity during immune system reconstitution.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 1 month and 45 years old and weigh at least 10 Kg.
Select...
I have had a stem cell transplant and my bone marrow is making blood cells.
Select...
I have a serious blood cancer and a stem cell transplant is recommended for me.
Select...
I do not have severe graft-versus-host disease needing high-dose steroids.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through day 60 (+/- 10 days) after infusion of t-allo10
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through day 60 (+/- 10 days) after infusion of t-allo10
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants who reach immune reconstitution (IR) threshold
Number of participants with absence of dose-limiting toxicity (DLT) 28 days following the infusion of T-allo10 given at the recommended phase 2 dose (RP2D)
Number of participants with myeloid engraftment after T-allo10
+2 moreSecondary outcome measures
Leukemia-free survival
Non-relapse mortality
Number of participants with cGvHD
+4 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment3 Interventions
The participant will undergo a alpha-beta depleted stem cell transplant using donor cells. The participant's cells will then be manipulated via a T-allo10 cell addback to reach a dose level of 1 X 10^6/kg
Group II: Cohort 2Experimental Treatment3 Interventions
The participant will undergo a alpha-beta depleted stem cell transplant using donor cells. The participant's cells will then be manipulated via a T-allo10 cell addback to reach a dose level of 3 X 10^5/kg
Group III: Cohort 1Experimental Treatment3 Interventions
The participant will undergo a alpha-beta depleted stem cell transplant using donor cells. The participant's cells will then be manipulated via a T-allo10 cell addback to reach a dose level of 1 X 10^5/kg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Allogeneic Stem Cell Transplant
2009
Completed Phase 2
~130
Find a Location
Who is running the clinical trial?
Porteus, Matthew, MDLead Sponsor
1 Previous Clinical Trials
12 Total Patients Enrolled
Stanford UniversityLead Sponsor
2,408 Previous Clinical Trials
17,343,417 Total Patients Enrolled
Roncarolo, Maria Grazia, MDLead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 1 month and 45 years old and weigh at least 10 Kg.I have had a stem cell transplant and my bone marrow is making blood cells.I am over 18 and can consent, or if I can't, someone can on my behalf. If under 18, my guardian will consent and I'll agree if I'm over 7.I or my donor cannot undergo an extra cell collection procedure before donating cells for the study.I have a serious blood cancer and a stem cell transplant is recommended for me.You have taken part in another research study within the past month.I do not have severe graft-versus-host disease needing high-dose steroids.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1
- Group 2: Cohort 3
- Group 3: 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.
Share this study with friends
Copy Link
Messenger