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NCT04640987 · ClinicalTrials.gov registry record · Phase 1
Stem Cell Transplant From Donors After Alpha Beta Cell Depletion in Children and Adults With T-allo10 Cells Addback
A Phase 1 study of Hematologic Diseases, sponsored by Porteus, Matthew, MD.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT04640987: Recruiting Phase 1 study of Hematologic Diseases, sponsored by Porteus, Matthew, MD.
NCT04640987 is a Phase 1 study of Hematologic Diseases that is actively recruiting participants, run by Porteus, Matthew, MD. The registered enrollment target is 22 participants, below the 2,237-participant average among 17 other Hematologic Diseases trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04640987, a Phase 1 study of Hematologic Diseases, is actively recruiting participants, sponsored by Porteus, Matthew, MD.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine the safety of a cell therapy, T-allo10, after αβdepleted-HSCT in the hopes that it will boost the adaptive immune reconstitution of the patient while sparing the risk of developing severe Graft-versus-Host Disease (GvHD). The primary objective of Phase 1a is to determine the recommended Phase 2 dose (RP2D) administered after infusion of αβdepleted-HSCT in children and young adults with hematologic malignancies. A Phase 1b extension will occur after dose escalation, enrolling at the RP2D for the T-allo10 cells determined in the Phase 1 portion to evaluate the safety and efficacy of infusion of T-allo10 after receipt of αβdepleted-HSCT. Additionally, Phase 1b aims to explore improvements in immune reconstitution. All participants on this study must be enrolled on another study: NCT04249830
Primary Outcome
RP2D was determined by testing 3 different escalating doses (1x10\^5, 3x10\^5 and 1x10\^6 cells/Kg recipient body weight) in dose escalation cohorts 1 to 3 with 3 to 6 participants each. RP2D reflects the acceptable dose levels that did not cause a Dose-Limiting Toxicity (DLT) in ≥33% of participants and resulted in success with response in \>83% of participants. DLTs were defined as Grade IV aGvHD post T-allo10 infusion; any grade 3 or 4 related TEAE; any grade 3 or 4 suspected AE. Success with
Conditions Studied
Interventions
- BIOLOGICAL Allogeneic Stem Cell Transplant
- DEVICE CliniMACS Prodigy System
- DRUG T-allo10 cells addback
Study Locations (1)
California
- Lucile Packard Children's Hospital - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2021-02-10 |
| Est. Completion | 2029-03 |
| Phase | Phase 1 |
What NCT04640987 shows while recruiting
NCT04640987 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 2,237-participant average among 17 other Hematologic Diseases trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Hematologic Diseases appearing as the primary indexed condition, and to 3 interventions - of which Allogeneic Stem Cell Transplant is the first listed.
NCT04640987 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04640987 about?
NCT04640987 is a clinical study titled "Stem Cell Transplant From Donors After Alpha Beta Cell Depletion in Children and Adults With T-allo10 Cells Addback". The purpose of this study is to determine the safety of a cell therapy, T-allo10, after αβdepleted-HSCT in the hopes that it will boost the adaptive immune reconstitution of the patient while sparing the risk of developing severe Graft-versus-Host Disease (GvHD). The primary objective of Phase 1a i...
What is the current status of trial NCT04640987?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2021-02-10. Estimated completion is 2029-03.
What conditions does trial NCT04640987 study?
This clinical trial studies the following conditions: Hematologic Diseases.
What interventions are being tested in trial NCT04640987?
The interventions under investigation include: Allogeneic Stem Cell Transplant (BIOLOGICAL), CliniMACS Prodigy System (DEVICE), T-allo10 cells addback (DRUG).
Who is sponsoring clinical trial NCT04640987?
This trial is sponsored by Porteus, Matthew, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04640987 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04640987's enrollment target sits among peer trials
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