Clinical trial · Interventional
Phase I of Infusion of Selected Donor NK Cells After Allogeneic Stem Cell Transplantation
Phase I of Infusion of Selected Donor NK Cells After HLA Identical Allogeneic Stem Cell Transplantation Prepared With Reduced Intensity Conditioning - DLI-NK/IPC 2012-003
- 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 goal of our study will be to determine the clinical and biological safety of infusing immuno-selected NK (Natural Killer) CD3-/CD56+ cells, early after allogeneic transplantation with colony stimulating factor (G-CSF) mobilized peripheral blood stem cells and Reduced Intensity Conditioning (RIC), as a potential substitute to usual "Donor Lymphocyte Infusion" (DLI), that contain the whole range of immune effectors. The trial will include several progressive steps: dose escalation up to a level compatible with the cost-effectiveness potential of the device and clinical situation and recombinant interleukin-2 (r-IL2) activation of selected NK cells in vitro prior to re-infusion.
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 |
|---|---|---|---|
| Hematological Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NK Cell infusion | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NK Cell infusion
- description
- * Cell collection o Lymphocytes will be harvest from the original and consenting donor as soon as possible around day 60 post transplantation * NK Cell selection o Cells will be obtained after double selection: CD3+ depletion followed by CD56+ selection using an european approved device (Miltenyi corporation) * NK Cell ex-vivo activation o ex-vivo activation: interleukin-2 according to a classical procedure (7 days at 37°C with RPMI clinical grade medium supplemented with 10% of foetal calf serum, 0.5 x 106 cellules / ml, 1000 U/ml d'IL-2 (interleukin, proleukin) * NK Cell infusion (60 to 90 days after transplantation)
- interventionNames
- Biological: NK Cell infusion
Primary outcomes (1)
- measure
- Occurence of grade 3-4 toxicity within 30 days of NK cells infusion
- timeFrame
- day 30
- description
- To establish the safety of donor NK cells infusion after HLA matched allogeneic transplant prepared by RIC.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient treated with allogeneic stem cell transplantation * Presenting an hematological malignancy with an intermediate, high or very high risk index according to the disease risk index developed by the Dana Farber Cancer Institute * Donor: HLA matched related or unrelated (10/10) donor * Graft: Peripheral stem cell transplant * Reduced Intensity Conditioning as used in the current transplant program: Fludarabine, IV Busulfan and Thymoglobuline 2. Age above 18 and under 70 3. Eastern Cooperative Oncology Group (ECOG) 0-1 or Karnofsky index ≥ 70 % 4. Survival expectation \> 6 months 5. Affiliation to social security 6. Signed informed consent from Donor and Patient Exclusion Criteria: 1. Active grade \>= 2 acute GVHD or corticotherapy ≥ 0.5 mg/kg/day at time of NK cell infusion 2. Active infection 3. Psychiatric disorder occurring after transplant 4. Pregnant or breast-feeding women or without contraception
References
Publications (2)
- RESULTDevillier R, Calmels B, Guia S, Taha M, Fauriat C, Mfarrej B, Venton G, Vivier E, Olive D, Chabannon C, Blaise D, Ugolini S. Phase I Trial of Prophylactic Donor-Derived IL-2-Activated NK Cell Infusion after Allogeneic Hematopoietic Stem Cell Transplantation from a Matched Sibling Donor. Cancers (Basel). 2021 May 28;13(11):2673. doi: 10.3390/cancers13112673. PMID 34071607
- RESULTMfarrej B, Gaude J, Couquiaud J, Calmels B, Chabannon C, Lemarie C. Validation of a flow cytometry-based method to quantify viable lymphocyte subtypes in fresh and cryopreserved hematopoietic cellular products. Cytotherapy. 2021 Jan;23(1):77-87. doi: 10.1016/j.jcyt.2020.06.005. Epub 2020 Jul 25. PMID 32718876