Clinical trial · Interventional
Memory T-cell Infusion to Improve Immunity After TCR-alpha/Beta Depleted Hematopoietic Stem Cell Transplantation
Transfusion of CD45RA-depleted Donor Lymphocytes to Improve Regeneration of Antimicrobial Immunity After TCR-alpha/Beta Depleted Hematopoietic Stem Cell Transplantation
NCT02337595CI-TRIAL-0002188445RA_NEG_DLIcompletedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The stud will evaluate whether infusions of CD45RA-depleted lymphocytes from the donor early post-transplant is a safe way to improve immunity to common infections in recipients of TCR-alpha/beta depleted hematopoietic stem cell grafts.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Marrow Failure Syndromes | — | UNRESOLVED | — |
| Graft vs Host Disease | — | UNRESOLVED | — |
| Immune Deficiency Disease | — | UNRESOLVED | — |
| Leukemia, Myeloid, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Opportunistic Infections | — | UNRESOLVED | — |
| Precursor T-Cell Lymphoblastic Leukemia-Lymphoma | T Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD45RA-depleted peripheral blood mononuclear cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Cumulative incidence of grade 2-4 acute graft-versus-host disease
- timeFrame
- 100 days
- description
- Cumulative incidence (competing risk model) of acute graft-versus-host disease
- measure
- Immune reconstitution (Quantitative evaluation of lymphocyte subsets in the peripheral blood, quantitative evaluation of pathogen-specific immune response by ELISPOT assay)
- timeFrame
- 120 days
- description
- Quantitative evaluation of lymphocyte subsets in the peripheral blood, quantitative evaluation of pathogen-specific immune response by ELISPOT assay
Secondary outcomes (3)
- measure
- 1-year survival
- timeFrame
- 1 year
- description
- Kaplan-Meyer estimate of overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: * recipient of allogeneic hematopoietic stem cell graft from haploidentical or matched unrelated donor * TCR alpha/beta depletion of the hematopoietic stem cell graft * CMV-seropositive donor * stable hematopoietic engraftment Exclusion Criteria: * active graft-versus-host disease grade 2-4 * any systemic immune suppressive therapy except calcineurin inhibitor monotherapy * uncontrolled sepsis
References
Publications (2)
- BACKGROUNDTeschner D, Distler E, Wehler D, Frey M, Marandiuc D, Langeveld K, Theobald M, Thomas S, Herr W. Depletion of naive T cells using clinical grade magnetic CD45RA beads: a new approach for GVHD prophylaxis. Bone Marrow Transplant. 2014 Jan;49(1):138-44. doi: 10.1038/bmt.2013.114. Epub 2013 Aug 12. PMID 23933765
- BACKGROUNDBleakley M, Heimfeld S, Jones LA, Turtle C, Krause D, Riddell SR, Shlomchik W. Engineering human peripheral blood stem cell grafts that are depleted of naive T cells and retain functional pathogen-specific memory T cells. Biol Blood Marrow Transplant. 2014 May;20(5):705-16. doi: 10.1016/j.bbmt.2014.01.032. Epub 2014 Feb 11. PMID 24525279