New cell therapy aims to supercharge immune recovery in young cancer patients
NCT ID NCT04640987
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests whether a special cell therapy called T-allo10 can safely help rebuild the immune system in children and young adults (up to age 45) with blood cancers who have received a stem cell transplant. The treatment is given after the transplant to speed up recovery of infection-fighting cells while trying to avoid severe graft-versus-host disease. The study involves 22 participants and aims to find the best dose and check for safety and immune improvement.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 22 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2021
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 month to 45 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria prior to enrollment: * 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: 1. High-risk ALL in 1st CR, ALL in 2nd or subsequent CR; 2. High-risk AML in 1st CR, AML in 2nd or subsequent CR; 3. Myelodysplastic syndrome; 4. JMML (Juvenile myelomonocytic leukemia); 5. Non-Hodgkin lymphomas in 2nd or subsequent CR; 6. 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. Inclusion criteria prior to T-allo10 infusion: 1. Patient already received αβdepleted-HSCT and has myeloid engraftment. 2. 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.: 1. Not eligible to receive HSCT on NCT04249830 2. Received another investigational agent within 30 days of enrollment. 3. Pregnancy (positive serum or urine beta-HCG) within 7 days of MNC donation. 4. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Lucile Packard Children's Hospital
RECRUITINGPalo Alto, California, 94305, United States
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Other studies related to the condition(s) this trial covers.
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- Can an HDAC inhibitor wipe out residual leukemia cells?
- Can an experimental pill block a cancer-driving enzyme in hard-to-treat leukemia?
- Patient's own t cells engineered to hunt lymphoma in early trial