Clinical trial · Interventional
Infusion of Donor Lymphocytes Depleted of CD25+ Regulatory T-cells in Patients With Relapsed Hematologic Malignancies
Infusion of Donor Lymphocytes Depleted of CD25+ Regulatory T-cells in Patients With Relapsed Hematologic Malignancies After Matched Allogeneic Hematopoietic Stem Cell Transplantation
- 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 purpose of this research study is to evaluate the safety and efficacy of cell depletion in a donor lymphocyte infusion (DLI) product with the use of the CliniMACS machine. Previously, patients with hematologic malignancies who have relapsed after transplant have been given infusions of donor white blood cells calsed donor lymphocyte infusion (DLI) as a way to boost their immune function and fight cancer. Information from other research studies suggests that lowering the number of a certain type of white blood cell called CD25+ Tregs in the DLI may allow for a greater effect. In this research study, we are looking for the appropriate dose of DLI depleted of the CD25+ Treg white blood cells that can be given safely.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CliniMACS CD25 Reagent Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CD25+ Treg depleted DLI dose schema
- description
- Patients will receive a defined dose of CD25+ Treg depleted DLI. 5 patients will be enrolled, initially at dose level B, and subsequent cohorts will be dose adjusted per the CD3+ dose escalation/de-escalation schema: * Dose level -C: 3x10\^7 (CD3+Dose (#cells/kg\*)) * Dose level -B: 1x10\^7 (CD3+Dose (#cells/kg\*)) * Dose level -A: 1x10\^6 (CD3+Dose (#cells/kg\*)) \*Recipient's body weight in Kg
- interventionNames
- Device: CliniMACS CD25 Reagent Device
Primary outcomes (2)
- measure
- To determine the feasibility of using the ClinMACS CD25 Reagent device to engineer a DLI product outlined in the protocol
- timeFrame
- 3 years
- measure
- To determine the safety of CD25+ Treg depleted DLI in this patient population.
- timeFrame
- 3 years
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with hematologic malignancies that have relapsed after HLA-A, -B, -C, and-DRBI matched allogeneic hematopoietic stem cell transplantation * At least 2 months following hematopoietic stem cell transplantation * Off any systemic immunosuppressive medication for treatment or prevention of GVHD, for a minimum of 2 weeks prior to study entry * Recipient with donor chimerism of 20% or greater within 6 weeks prior to DLI * Patient with less than 50% bone marrow involvement (% cellularity) and less than 5cm lymph nodes, in the 6 weeks prior to DLI * 18 years of age or older * ECOG Performance Status score 0-2 * Prior stem cell donor is medically fit to undergo leukapheresis procedure Exclusion Criteria: * Relapsed CML in chronic phase * Prior donor lymphocyte infusion or other immunotherapy treatment within 8 weeks prior to enrollment * Chemotherapy within 4 weeks prior to enrollment * Clinically significant and active autoimmune disease in donor or patient. This is defined as autoimmune disease resulting in organ dysfunction and/or requiring systemic therapy * Evidence of active acute or chronic GVHD * Uncontrolled infection
References
Publications (1)
- DERIVEDNikiforow S, Kim HT, Daley H, Reynolds C, Jones KT, Armand P, Ho VT, Alyea EP 3rd, Cutler CS, Ritz J, Antin JH, Soiffer RJ, Koreth J. A phase I study of CD25/regulatory T-cell-depleted donor lymphocyte infusion for relapse after allogeneic stem cell transplantation. Haematologica. 2016 Oct;101(10):1251-1259. doi: 10.3324/haematol.2015.141176. Epub 2016 Jun 27. PMID 27354021