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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 Stanford University
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 below
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I am between 1 month and 45 years old and weigh at least 10 Kg.
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I have had a stem cell transplant and my bone marrow is making blood cells.
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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.
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I have a serious blood cancer and a stem cell transplant is recommended for me.
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I do not have severe graft-versus-host disease needing high-dose steroids.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through day 60 (+/- 10 days) after infusion of t-allo10
This trial's timeline: 3 weeks for screening, Varies for treatment, and through day 60 (+/- 10 days) after infusion of t-allo10 for reporting.

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 more
Secondary outcome measures
Leukemia-free survival
Non-relapse mortality
Number of participants with cGvHD
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental: Stem Cell TransplantExperimental Treatment3 Interventions
The participant will undergo a stem cell transplant using donor cells that have been manipulated through an investigational device. The participant's cells will then be manipulated via a T-allo10 cell addback. Participants will be followed for outcomes for two years.
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?

Stanford UniversityLead Sponsor
2,379 Previous Clinical Trials
17,333,371 Total Patients Enrolled
Roncarolo, Maria Grazia, MDLead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
California Institute for Regenerative Medicine (CIRM)OTHER
63 Previous Clinical Trials
3,132 Total Patients Enrolled

Media Library

Allogeneic Stem Cell Transplant (Stem Cell Transplant) Clinical Trial Eligibility Overview. Trial Name: NCT04640987 — Phase 1
Blood Diseases Research Study Groups: Experimental: Stem Cell Transplant
Blood Diseases Clinical Trial 2023: Allogeneic Stem Cell Transplant Highlights & Side Effects. Trial Name: NCT04640987 — Phase 1
Allogeneic Stem Cell Transplant (Stem Cell Transplant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04640987 — Phase 1

Frequently Asked Questions

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

Does this trial cater to subjects aged 55 and over?

"Eligible participants for this trial must be aged between 1 Month and 45 years."

Answered by AI

Who is eligible to participate in this clinical investigation?

"To qualify for this medical trial, applicants must be suffering from a hematologic disease and have an age ranging between one month to forty-five years old. At present, 22 individuals are being accepted into the study."

Answered by AI

Does the Food and Drug Administration recognize T-allo10 cell supplementation as a viable treatment?

"Because the T-allo10 cells addback is currently in a trial's first phase, there is insufficient evidence demonstrating efficacy or safety. Therefore, Power assigned this pharmaceutical an initial score of 1."

Answered by AI

What is the participant threshold for this medical trial?

"Affirmative. Clinicaltrials.gov confirms that this clinical trial, first posted on January 20th 2020 is actively recruiting participants. 22 patients are needed from 1 site in order to reach the desired sample size."

Answered by AI

Are there any vacancies for this medical experiment currently available?

"Affirmative, the information available on clinicaltrials.gov indicates that this experiment is in search of participants. Initially posted to the website on January 20th 2020, it was last updated on March 25th 2022 and requires 22 people from a single medical site."

Answered by AI
~6 spots leftby Dec 2025