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Hematologic DiseasesPhase 1NCT04640987

Stem Cell Transplant From Donors After Alpha Beta Cell Depletion in Children and Adults With T-allo10 Cells Addback

A Phase 1 study testing Allogeneic Stem Cell Transplant, CliniMACS Prodigy System and T-allo10 cells addback in people with Hematologic Diseases, run by Porteus, Matthew, MD at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 1 month to 45 years
Conditions the study is for
Hematologic Diseases
What is being tested?
Allogeneic Stem Cell Transplant, CliniMACS Prodigy System and T-allo10 cells addback
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
10 Feb 2021to Mar 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 month to 45 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 1. Age > 1 months (with minimum weight of 10 Kg) and < 45 years.
  • 2. Patients deemed eligible for allogeneic HSCT under the originating study, NCT 04249830
  • 3. Patients with life-threatening hematological malignancies for which HSCT has been recommended:
  • High-risk ALL in 1st CR, ALL in 2nd or subsequent CR;
  • High-risk AML in 1st CR, AML in 2nd or subsequent CR;
  • Myelodysplastic syndrome;
Show all 17Show fewer
  • JMML (Juvenile myelomonocytic leukemia);
  • Non-Hodgkin lymphomas in 2nd or subsequent CR;
  • Other hematologic malignancies eligible for stem cell transplantation per institutional standard.
  • 4. All subjects ≥ 18 years of age must be able to give informed consent, or adults lacking capacity to consent must have a LAR available to provide consent. For subjects <18 years old their LAR (i.e. parent or guardian) must give informed consent. Pediatric subjects will be included in age appropriate discussion and verbal assent will be obtained for those > 7 years of age, when appropriate.
  • Patient already received αβdepleted-HSCT and has myeloid engraftment.
  • Absence of active grade II aGvHD requiring >0.5 mg/Kg of steroids or any diagnosis of grade III/IVaGvHD.
  • Exclusion Criteria prior to MNC collection for Tallo-10 manufacturing.:
  • Not eligible to receive HSCT on NCT04249830
  • Received another investigational agent within 30 days of enrollment.
  • Pregnancy (positive serum or urine beta-HCG) within 7 days of MNC donation.
  • Patient or donor is not willing or able to undergo an additional non-mobilized apheresis for collection of MNC prior to donation of cells for participation in NCT04249830.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

  • Lucile Packard Children's Hospital

    Palo Alto, California, 94305

    Stem Cell and Gene Therapy Clinical Trials Program, 650-723-0912, DL-SCTIntakeCoordinators@stanfordchildrens.org

    Rosa Bacchetta, MD

    Recruiting

Other trials in United States

About this study

Official title: Phase 1/1b Study of T-allo10 Infusion After HLA-Partially Matched Related or Unrelated TCR αβ+ T-cell/ CD19+ B-cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation (αβ Depleted-HSCT) in Children and Young Adults Affected by Hematologic Malignancies

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.

Read more

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

Being tested
Allogeneic Stem Cell Transplant, CliniMACS Prodigy System, T-allo10 cells addback
Medical subject headings
Hematologic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Allogeneic Stem Cell TransplantBiological

    The allogeneic stem cell transplant involves transferring the stem cells from a healthy person (donor) to the participant via infusion.

  • CliniMACS Prodigy SystemDevice

    Device used for production of T-allo10 cells.

  • T-allo10 cells addbackDrug

    T-allo10 cells are made by manipulating the participant's stem cell donor's white blood cells (CD4+ T cells) in the presence of their (participant's) CD14+ monocytes.

Study groups in NCT04640987
Study groupRoleWhat they receive
Cohort 1ExperimentalThe 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
Receives: Biological: Allogeneic Stem Cell Transplant; Device: CliniMACS Prodigy System; Drug: T-allo10 cells addback
Cohort 2ExperimentalThe 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
Receives: Biological: Allogeneic Stem Cell Transplant; Device: CliniMACS Prodigy System; Drug: T-allo10 cells addback
Cohort 3ExperimentalThe 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
Receives: Biological: Allogeneic Stem Cell Transplant; Device: CliniMACS Prodigy System; Drug: T-allo10 cells addback

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recommended Phase 2 Dose (RP2D) of T-allo10 in Phase 1a

    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 response was defined as achieving CD4+ IR by Day +60 (+/- 10 days) after αβdepleted-HSCT.

    Measured: Up to 28 days after infusion of T-allo10 for each dosing cohort and Day +60 (+/- 10 days) after αβdepleted-HSCT

  2. Number of participants with absence of dose-limiting toxicity (DLT)

    Grade IV aGvHD post T-allo10 infusion; any grade 3 or 4 related treatment emergent adverse events (TEAE); any grade 3 or 4 suspected AE

    Measured: Assessed at 28 days (after infusion of T-allo10)

  3. Number of participants who reach immune reconstitution (IR) threshold

    IR (a surrogate of reduced risk of leukemia recurrence) is defined reaching the threshold of 50CD3+CD4+T-cells/µl by Day+60 (+/-10days).

    Measured: Up to Day 60 (+/- 10 days) after αβdepleted-HSCT

Secondary outcomes (7)

  1. Number of participants with ≥grade 3 adverse event related to T-allo10 infusion

    Measured: Through 1 year after αβdepleted-HSCT

  2. Number of participants with grade II-IV aGvHD

    Cumulative incidence of acute GvHD (graded as II-IV using the Magic criteria)

    Measured: Assessed at day 90 and day 180 after αβdepleted-HSCT

  3. Number of participants with grade III-IV aGvHD

    Cumulative incidence of acute GvHD (graded as III-IV using the Magic criteria)

    Measured: Assessed at day 90 and day 180 after αβdepleted-HSCT

  4. Number of participants with cGvHD

    Chronic GvHD is graded according to the NIH Consensus Conference criteria

    Measured: Assessed at 1 year after αβdepleted-HSCT

  5. Number of participants who achieved leukemia-free survival

    Leukemia-free survival defined as at the time of enrollment to disease relapse or death from any cause.

    Measured: Assessed at 1 year after αβdepleted-HSCT

  6. Number of participants with disease relapse

    Disease relapse is defined as the return of signs and symptoms of a disease after a remission.

    Measured: Assessed at 1 year after αβdepleted-HSCT

  7. Non-relapse mortality

    Non-relapse mortality is defined as death not preceded by recurrent primary malignancy

    Measured: Assessed at Day 90, 1 year after αβdepleted-HSCT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2020
  2. Study start10 Feb 2021
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04640987
Sponsor's protocol ID
IRB-58549
Other IDs
BMT 367 - T-allo10 Alpha Beta
Status last verified
Jan 2026
First submitted
17 Nov 2020
Last updated
8 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Allogeneic Stem Cell Transplant, CliniMACS Prodigy System and T-allo10 cells addback in people with Hematologic Diseases, run by Porteus, Matthew, MD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended Phase 2 Dose (RP2D) of T-allo10 in Phase 1a (time frame: Up to 28 days after infusion of T-allo10 for each dosing cohort and Day +60 (+/- 10 days) after αβdepleted-HSCT). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04640987.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.

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