Clinical trial · Interventional
Prophylactic Application of Donor-derived TCM After Allogeneic HSCT
Prophylactic Application of Donor-derived Central Memory T Lymphocytes (TCM) After Allogeneic HSCT to Prevent Infectious Complications
- 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)
PACT is a non-randomized multicentre phase I/II study to evaluate the feasibility and safety of the prophylactic administration of donor derived TCM. Patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) who are planned to undergo a HLA -matched (9/10 or 10/10) allogeneic hematopoietic stem cell transplantation and who are either 50+ years old or have a high comorbidity score are included according to criteria as described below. TCM will be applied in escalating doses to a maximum of 30 patients who have received T cell depleted Human leukocyte antigen (HLA)-matched alloHSCT grafts and qualify for TCM transfer.
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 |
|---|---|---|---|
| Leukemia, Myeloid, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TCM allogeneic humane central memory T cells, cryopreserved | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Experimental: TCM allogeneic humane central memory T cells, cryopreserved Solution for injection (intravenous use) up to 65\*10\^4 TCM /kg body weight patient will receive investigational product 3 times (Day 30, Day 60, Day 90 after alloHSCT)
- interventionNames
- Biological: TCM allogeneic humane central memory T cells, cryopreserved
Primary outcomes (1)
- measure
- Cumulative incidence of acute GVHD > overall grade II or death
- timeFrame
- during three months after the infusion of the T cell product
- description
- Toxicity of the infusion will be evaluated by the cumulative incidence of acute GVHD \> overall grade II or death during three months after the infusion of the T cell product.
Secondary outcomes (10)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: Patient * Male or female patients with Hematopoietic Cell Transplant-Co-morbidity Index (HCT-CI) score (Sorror) ≥3 AND/or Age 50 years or older * Primary or secondary AML Month 0, Month 1, Month 2, Month 4, Month 5, Month 6 and Month 7, in Complete Remission (CR) (\<5% blasts in bone marrow (BM)) irrespective of the cytogenetic or molecular risk profile or MDS up to Refractory anemia with excess of blasts 2 (RAEB-2) (maximal 20% blasts in bone marrow) * Planned alloHSCT with Cluster of Differentiation 34+ (CD34+)-purified stem cell grafts after conditioning with fludarabine-melphalan-thio-thepa-ATG (ATG=Antithymocyte globulin) * HLA-matched stem cell donor (9-10/10, maximal 1 allel- or antigen mismatch allowed) without aberrant CD45RA (=Cluster of Differentiation) expression Additional patient inclusion criteria: Treatment phase patients at day 30 +/-5 after alloHSCT: -Stable engraftment of the allogeneic graft (granulocytes \> 0.5\*109/L) Donor * Donor must have met requirements of European Union (EU) Tissue and Cells Directive (2004/23/EC) (see below) * Healthy donor - having passed medical examination for stem cell donation * Donor must fulfill the requirements for allogeneic donor blood testing according to Richtlinie zur Herstellung und Anwendung von hämatopoetischen Stammzellzubereitungen (SC-Richtlinie (RILI) der Bundesärztekammer; 08/2014) * Donor informed consent for the additional non-mobilized apheresis * Written informed consent of the patient Exclusion Criteria: * Patient * Disease-specific treatment foreseen in the first 6 months after alloHSCT * Patients with AML M3 * Pregnant or lactating women * Severe psychological disturbances * Positive serology for Human immunodeficiency virus (HIV), Syphilis, West Nile Virus (WNV) * Participation in another interventional clinical trial during or within 4 weeks before study entry Additional patient exclusion criteria: Treatment phase patients at day 30 +/-5 after alloHSCT: * Disease specific treatment foreseen in the first 6 months after alloHSCT * Acute GVHD \> grade I for which immune suppressive treatment is given * Progressive disease for which therapy is needed * Use of \> 0,5 mg/kg bw prednisone a day * Life expectation \< 12 weeks * End stage irreversible multi-system organ failure Donor * Donor pregnant or lactating * Donors with aberrant CD45RA isoform expression * General exclusion criteria for stem cell donation
References
Publications (0)
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