Clinical trial · Interventional
Ex Vivo TCR αβ T Cell Depletion for Graft-Versus-Host Disease Prophylaxis in Mismatched Donor Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies
A Phase 2 Study of Ex Vivo TCR αβ T Cell Depletion for Graft-Versus-Host Disease (GVHD) Prophylaxis in Mismatched Donor Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was prematurely closed to enrollment due to feasibility issues, as the site has promising upcoming competing trials, and the study was already not enrolling at a rate sufficient to meet the accrual goal.
Summary
Brief summary (as posted)
This research study is studying the removal of a subset of white blood cells (called alpha/beta T cells) from the donor product using a cell separation device before the product is transplanted into the participant. The device used to remove the α/βT cells in this study is: -CliniMACS® TCR α/β Reagent System
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 Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ClinicMACs | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TCR α/β Reagent System
- description
- * The stem cell apheresis product will be depleted of TCRαβ T cells by negative selection using the automated CliniMACS® Plus device. * CD34+ stem cell counts will be obtained before and after processing with the Miltenyi ClinicMACs device
- interventionNames
- Device: ClinicMACs
Primary outcomes (1)
- measure
- Number of Participants With Severe Acute GVHD-free Survival
- timeFrame
- 100 Days
- description
- Number of participants with severe acute GVHD-free survival will be assessed at 100 days post-SCT
Secondary outcomes (11)
- measure
- Number of Participants With Grades II-IV Acute GVHD
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnoses and stage at time of transplant admission: * Acute leukemia (AML or ALL or MPAL) in first or subsequent remission * Myelodysplastic syndromes (MDS) with \<10% marrow blasts * Myeloproliferative neoplasm (MPN) with \<10% marrow blasts * CMML with less than 10% marrow blast * CML accelerated phase or second or subsequent chronic phase * Non-Hodgkin's lymphoma in PR or CR2 or beyond * Hodgkin lymphoma in PR or CR2 or beyond * Age 18-65 years * Patient has a related or unrelated donor who is 8 or 9 out of 10 match at HLA A, B, C, DRB1 and DQB1, based on allele level typing. * Patient ECOG performance status 0-2 (Karnofsky ≥60%, see Appendix A) * Patient deemed to be appropriate candidate for myeloablative conditioning transplantation. * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patient with active HIV infection * Chronic active hepatitis B infection (HepB surface Ag+ or detectable Hep B viral load) * Prior allogeneic hematopoietic stem cell transplantation * Impaired cardiac function- ejection fraction \< 40% * Impaired pulmonary function- pretransplant FEV1, DLCO \< 50% * Impaired renal function, based on --Serum creatinine \> 2.0 mg/dl * Impaired liver function unrelated to primary disease, based on --ALT or AST \> 3x ULN, or Total Bilirubin \> 2.0mg/dl (with exception for known or suspected Gilbert's disease) * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Women who are pregnant or breast feeding. Women of child bearing potential must have a negative serum pregnancy test at study entry. * Participants who are receiving any other investigational agents are eligible but such agent must be discontinued before admission for HSCT, and if resumption of investigation agent is planned after HSCT, this must be approved by the study PI. * Participants with known active CNS disease. CNS disease that has been treated is eligible
References
Publications (0)
Data not yet available