Clinical trial · Interventional
Dose-ranging Study of a Single Administration of T-cell Add-back Depleted of Host Alloreactive Cells in Patients Undergoing a Peripheral Blood Stem Cell Transplant From a Related, Haploidentical Donor
Phase I, Dose-ranging, Open-label, Study of a Single Administration of T-cells Add-back Depleted of Host Alloreactive Cells Using Theralux™ Therapy, Following Haploidentical Peripheral Blood Stem Cell Transplantation Submitted to CD34+ Cell Selection, in Patients With Severe Hematologic Malignancies
- 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 study is to determine the maximum tolerated dose and evaluate the safety of the administration of donor lymphocytes depleted of alloreactive T-cells following a stem cell transplant from a related, haploidentical donor, in patients with severe hematologic malignancies.
Conditions
Conditions (2)
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 Diseases | — | UNRESOLVED | — |
| Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Donor lymphocyte preparation depleted of functional host alloreactive T-cells (ATIR) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- L1 (dose 1.0x10E4 T-cells/kg)
- interventionNames
- Biological: Donor lymphocyte preparation depleted of functional host alloreactive T-cells (ATIR)
- type
- EXPERIMENTAL
- label
- L2 (dose 5.0x10E4 T-cells/kg)
- interventionNames
- Biological: Donor lymphocyte preparation depleted of functional host alloreactive T-cells (ATIR)
- type
- EXPERIMENTAL
- label
- L3 (dose 1.3x10E5 T-cells/kg)
- interventionNames
- Biological: Donor lymphocyte preparation depleted of functional host alloreactive T-cells (ATIR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Any of the following hematologic malignancies: very high risk leukemia, acute leukemia, chronic myeloid leukemia (CML), lymphoma, multiple myeloma (MM), myelodysplastic syndrome (MDS) * Incompatibility at two to three loci (HLA-A, B and/or DR) or a single DR locus of the unshared haplotype between the donor and recipient * Life expectancy of at least 3 months * Satisfactory performance status (ECOG ≤ 2); Exclusion Criteria: * Possibility of performing an allogeneic transplant with an HLA (human leukocyte antigen) matched sibling donor * Availability of an 6/6 HLA-A, B and DRB1 matched unrelated donor within 2-3 months; * Pregnancy * Viral hepatitis (B or C) * Active serious infectious process * HIV positivity; * Systemic dysfunction (cardiac, pulmonary, hepatic and renal) contra-indicating allogeneic stem cell transplantation * Prior allogeneic transplantation * Prior autologous transplantation within twelve months of baseline visit * Any abnormal condition or laboratory result that is considered by the principal investigator capable of altering patient condition or study outcome * Active central nervous system (CNS) disease at baseline * Participation in a trial with an investigational agent within 30 days prior to entry in the study * Malignant cells in circulating peripheral blood (\> 25%) * Other active malignant disease that would severely limit life expectancy
References
Publications (1)
- DERIVEDRoy DC, Lachance S, Cohen S, Delisle JS, Kiss T, Sauvageau G, Busque L, Ahmad I, Bernard L, Bambace N, Boumedine RS, Guertin MC, Rezvani K, Mielke S, Perreault C, Roy J. Allodepleted T-cell immunotherapy after haploidentical haematopoietic stem cell transplantation without severe acute graft-versus-host disease (GVHD) in the absence of GVHD prophylaxis. Br J Haematol. 2019 Sep;186(5):754-766. doi: 10.1111/bjh.15970. Epub 2019 May 28. PMID 31135970