Clinical trial · Interventional
Safety and Efficacy of Two Doses of ATIR101, a T-lymphocyte Enriched Leukocyte Preparation Depleted of Host Alloreactive T-cells, in Patients With a Hematologic Malignancy Who Received a Hematopoietic Stem Cell Transplantation From a Haploidentical Donor
An Exploratory, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of a Two-dose Regimen of ATIR101, a T-lymphocyte Enriched Leukocyte Preparation Depleted ex Vivo of Host Alloreactive T-cells (Using Photodynamic Treatment), in Patients With a Hematologic Malignancy, Who Received a CD34-selected Hematopoietic Stem Cell Transplantation From a Haploidentical Donor
- 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 whether a repeat dose administration of ATIR101 is safe and effective when infused in patients with a hematologic malignancy following a T-cell depleted stem cell graft from a related haploidentical donor. All patients are planned to receive two ATIR101 doses of 2×10E6 viable T-cells/kg, unless the second dose is reduced or halted for safety reasons.
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 |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ATIR101 | Biological | — | UNRESOLVED |
| Haploidentical hematopoietic stem cell transplantation (HSCT) | Procedure | — | UNRESOLVED |
| Non-TBI regime | Procedure | — | UNRESOLVED |
| TBI regime | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ATIR101
- interventionNames
- Biological: ATIR101
- Procedure: Haploidentical hematopoietic stem cell transplantation (HSCT)
- Procedure: TBI regime
- Procedure: Non-TBI regime
Primary outcomes (1)
- measure
- Incidence of Acute Graft Versus Host Disease (GVHD) Grade III/IV
- timeFrame
- 180 days post HSCT
Secondary outcomes (8)
- measure
- Incidence and Severity of Acute and Chronic GVHD
- timeFrame
- Between 6 and 12 months after HSCT
- measure
- Percentage of Participants Who Achieved T-Cell Reconstitution at 6 and 12 Months Post HSCT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Any of the following hematologic malignancies: * Acute myeloid leukemia (AML) in first remission with high-risk features or in second or higher remission * Acute lymphoblastic leukemia (ALL) in first remission with high-risk features or in second or higher remission * Myelodysplastic syndrome (MDS): transfusion-dependent, or intermediate or higher IPSS-R risk group * Karnofsky performance status ≥ 70% * Eligible for haploidentical stem cell transplantation according to the investigator * Male or female, age ≥ 18 years and ≤ 65 years Exclusion Criteria: * Availability of a fully matched related or unrelated donor following a donor search * Diffusing capacity for carbon monoxide (DLCO) \< 50% predicted * Left ventricular ejection fraction \< 50% (evaluated by echocardiogram or MUGA) * AST \> 2.5 x ULN (CTCAE grade 2) * Bilirubin \> 1.5 x ULN (CTCAE grade 2) * Creatinine clearance \< 50 mL/min (calculated or measured) * Positive HIV test * Positive pregnancy test (women of childbearing age only) * Prior allogeneic HSCT * Estimated probability of surviving less than 3 months * Known allergy to any of the components of ATIR101 (e.g., dimethyl sulfoxide) * Known presence of HLA antibodies against the non-shared donor haplotype * Any other condition which, in the opinion of the investigator, makes the patient ineligible for the study Inclusion Criteria Donor: * Haploidentical family donor with 2 to 3 mismatches at the HLA-A, -B and/or -DR loci of the unshared haplotype * Male or female, age ≥ 16 and ≤ 75 years (If applicable, local legal requirements for donors under the age of 18 will be followed) * Eligible for donations of human blood and blood components according to local requirements and regulations * Eligible for donation according to the transplantation center Exclusion Criteria Donor: * Positive pregnancy test or nursing (women of childbearing age only) * Positive viral test for HIV-1, HIV-2, HBV, HCV, Treponema pallidum, HTLV 1 (if tested), HTLV-2 (if tested), or WNV (if tested)
References
Publications (0)
Data not yet available