Clinical trial · Interventional
T-cell Receptor α/β Depleted Donor Lymphocyte Infusion
Phase I Dose Escalation of T-cell Receptor α/β Depleted Donor Lymphocyte Infusions Following CD34+- Selected Allogeneic Stem Cell Transplantation From Related & Unrelated Donors in Patients With Lymphoid, Myeloid or Plasma Cell 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 met criteria for stopping due to lack of efficacy per protocol specifications.
Summary
Brief summary (as posted)
This pilot study is being conducted to treat patients who have a certain type of malignancy (lymphoid or myeloid) with immune effector cells after a T-cell depleted allogeneic hematopoietic cell transplantation (TCD HSCT). This study is designed to see whether an investigational cellular product of immune cells obtained from a donor's cells that have been treated so that the type of cells that can lead to graft vs host disease have been removed can be safely administered. These cell products are administered following the initial stem cell transplant to assess the effect and improvement on minimal residual disease status, infectious complication, progression-free and overall survival.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoid Leukemia, Acute | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Myeloid Malignancy | — | UNRESOLVED | — |
| Plasma Cell Tumor | Plasma Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| T-cell Receptor α/β Depleted Donor Lymphocyte Infusions | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- HLA Matched Cohort I
- description
- 5 x 10\^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C)
- interventionNames
- Biological: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions
- type
- EXPERIMENTAL
- label
- HLA Matched Cohort II
- description
- 5 x 10\^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10\^6/kg 3-4 weeks after first dose, and 1 x 10\^6/kg 3-4 weeks after second dose
- interventionNames
- Biological: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions
- type
- EXPERIMENTAL
- label
- HLA Matched Cohort III
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with hematologic malignancies that are candidates CD34+ selected, T-cell depleted allogeneic hematopoietic stem cell transplantation. * Patients must have a Karnofsky (adult) Performance Status of at least 70%. * Patients must have adequate organ function measured by: * Cardiac: asymptomatic or if symptomatic then left ventricular ejection fraction (LVEF) at rest must be 50% and must improve with exercise. * Hepatic: \< 3x upper limit of normal (ULN) AST and \< 1.5 mg/dL total serum bilirubin, unless there is congenital benign hyperbilirubinemia. Patients with higher bilirubin levels due to causes other than active liver disease is also eligible with Pl approval (e.g., patients with PNH, Gilbert's disease or other hemolytic disorders). * Renal: serum creatinine: ≤ 1.2 mg/dL or if serum creatinine is outside the normal range, then creatinine clearance (CrCl) \> 40 mL/min (measured or calculated/estimated). * Pulmonary: asymptomatic or if symptomatic, diffusing capacity of the lungs for carbon monoxide (DLCO) 50% of predicted (corrected for hemoglobin). * Each patient must be willing to participate as a research subject and must sign an informed consent form. Exclusion Criteria: * Patients with active acute GvHD.
References
Publications (32)
- BACKGROUNDSeggewiss R, Einsele H. Immune reconstitution after allogeneic transplantation and expanding options for immunomodulation: an update. Blood. 2010 May 13;115(19):3861-8. doi: 10.1182/blood-2009-12-234096. Epub 2010 Mar 9. PMID 20215642
- BACKGROUNDLang P, Handgretinger R. Haploidentical SCT in children: an update and future perspectives. Bone Marrow Transplant. 2008 Oct;42 Suppl 2:S54-9. doi: 10.1038/bmt.2008.285. PMID 18978746
- BACKGROUNDReisner Y, Hagin D, Martelli MF. Haploidentical hematopoietic transplantation: current status and future perspectives. Blood. 2011 Dec 1;118(23):6006-17. doi: 10.1182/blood-2011-07-338822. Epub 2011 Sep 14. PMID 21921045
- BACKGROUNDJagasia M, Arora M, Flowers ME, Chao NJ, McCarthy PL, Cutler CS, Urbano-Ispizua A, Pavletic SZ, Haagenson MD, Zhang MJ, Antin JH, Bolwell BJ, Bredeson C, Cahn JY, Cairo M, Gale RP, Gupta V, Lee SJ, Litzow M, Weisdorf DJ, Horowitz MM, Hahn T. Risk factors for acute GVHD and survival after hematopoietic cell transplantation. Blood. 2012 Jan 5;119(1):296-307. doi: 10.1182/blood-2011-06-364265. Epub 2011 Oct 18. PMID 22010102
- BACKGROUNDArora M, Klein JP, Weisdorf DJ, Hassebroek A, Flowers ME, Cutler CS, Urbano-Ispizua A, Antin JH, Bolwell BJ, Boyiadzis M, Cahn JY, Cairo MS, Isola L, Jacobsohn DA, Jagasia M, Klumpp TR, Lee SJ, Petersdorf EW, Santarone S, Gale RP, Schouten HC, Spellman S, Wingard JR, Horowitz MM, Pavletic SZ. Chronic GVHD risk score: a Center for International Blood and Marrow Transplant Research analysis. Blood. 2011 Jun 16;117(24):6714-20. doi: 10.1182/blood-2010-12-323824. Epub 2011 Apr 14. PMID 21493797
- BACKGROUNDChao NJ, Schmidt GM, Niland JC, Amylon MD, Dagis AC, Long GD, Nademanee AP, Negrin RS, O'Donnell MR, Parker PM, et al. Cyclosporine, methotrexate, and prednisone compared with cyclosporine and prednisone for prophylaxis of acute graft-versus-host disease. N Engl J Med. 1993 Oct 21;329(17):1225-30. doi: 10.1056/NEJM199310213291703.