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AlloSCT for Malignant and Non-malignant Hematologic Diseases Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment20 people
  • Recruiting US sites1
  • SponsorMitchell Cairo
  • RegistryNCT04099966

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

AlloSCT for Malignant and Non-malignant Hematologic Diseases Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion: a one-minute explainerNCT040999661 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age1 Day to 30 Years
  • SexAll
  • Healthy volunteersNo

You may be able to join if

  • ALL:ALL high risk including one or more of the following: (t(9;22) or 11q23 chromosomal abnormality, primary induction failure (<15% blasts at time of registration), mixed phenotype acute leukemia (MPAL), persistent MRD (<0.01% by flow or persistent abnormal karyotype detected by cytogenetics) or hypodiploidy (44 chromosomes)) in first remission ' ALL in second remission and beyond;
  • AML: History of AML induction/reinduction Failure (<15% blasts at time of registration); AML in CR1 with poor cytogenetics (i.e. 12p, 5a, -7, FLT3 mutation/duplication, t(9;11) and others); AML with persistent minimal residual disease (MRD) in CR1(<0.01% on flow or persistent abnormal karyotype detected by cytogenetics); AML CR2 or beyond; AML in refractory relapse but ≤15% bone marrow leukemia blasts; Therapy-related AML
  • High Risk Myelodysplastic syndrome (MDS) 4 Lymphoma: Hodgkin (HL) or Non-Hodgkin (NHL): HL or NHL in induction failure; HL or NHL in PR1 or PR2 ; HL or NHL in CR2 or subsequent remission
  • Bone marrow failure syndromes: Kostmann syndrome refractory or intolerant to granulocyte colony-33stimulating factor; Diamond-Blackfan anemia refractory or intolerant to corticosteroids and/or cyclosporine'; amegakaryocytic thrombocytopenia 6. Sickle Cell Disease (Homozygous Hemoglobin S Disease, or Hemoglobin S β 0/+ thalassemia, or Hemoglobin SC Disease) 7. age 0-30 years 8. adequate organ function

You cannot join if

  • Females who are pregnant or breast-feeding are not eligible.
  • Patients with documented uncontrolled infection at the time of study entry are not eligible.
  • Karnofsky/Lansky (age appropriate) Performance Score <60
  • Demonstrated lack of compliance with medical care
  • Patients who have received allogeneic HSCT within 6 months, unless being done as a boost.
  • Patients with active <Grade 2 GVHD.

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

  • alpha beta depletion (Drug): donor cells will be collected and subsequently undergo α/β CD3+/CD19+ cell depletion.

The study

Treatment groups

Na · Single Group · masking: None

alpha beta cell depletion (Experimental)

Matched allogeneic donor stem cells will be processed utilizing α/β CD3+/CD19+ cell depletion with the Prodigy system. Standard pre-conditioning and post-transplant motioning will be given.

Goals

What the study measures

Main goals

  • incidence of adverse events related to administration of α/β CD3+/CD19+ cell depleted stem cells (1 year)

Other goals

  • incidence of hematpoitic engraftment following Allogeneic stem cell transplantation (AlloSCT) utilizing α/β CD3+/CD19+ cell depletion
  • incidence of GVHD following Allogeneic stem cell transplantation (AlloSCT) utilizing α/β CD3+/CD19+ cell depletion

Planned enrollment: 20 (estimated).

Where

Recruiting US sites

  • New York Medical College, Valhalla, New York

Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 22, 2026. Public record; not medical advice.

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