Clinical trial · Interventional
CD56+CD3- NK Cells Following Allogeneic Stem Cell Transplantation
Safety and Toxicity of Escalating Doses of Adoptively Infused ex Vivo Selected CD56+CD3- NK Cells on Day 7 Following Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies.
NCT01336478CI-TRIAL-00018176withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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 investigators propose a nonrandomized, Phase I study to assess the safety of infusion of NK cells that will be selected from sibling donors and infused to patients with hematological malignancies early following allogeneic stem cell transplantation.
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 |
|---|---|---|---|
| Allogeneic Stem Cell Transplant | — | UNRESOLVED | — |
| CD56+CD3- NK Cells | — | UNRESOLVED | — |
| Haematological Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Haematology / Blood chemistry sampling | Procedure | — | UNRESOLVED |
| Infusion of donor derived ex-vivo selected NK cells to patients after transplant | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Safety and toxicity donor CD56+CD3- NK cells
- timeFrame
- Day 28 post NK cell infusion
- description
- To evaluate the safety and toxicity of escalating doses of ex vivo selected donor CD56+CD3- NK cells, adoptively infused on day 7 following sibling allogeneic stem cell transplantation in patients with hematological malignancies. We will specifically look for the proportion of patients who develop infusion related toxicity. Toxicity will be defined as per the Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
Secondary outcomes (3)
- measure
- Donor neutrophil and platelet engraftment
- timeFrame
- Day 28 post stem cell infusion
- description
- Donor neutrophil engraftment (Neut \> 0.5 x10\^9/L) and platelet engraftment (Plt \> 20 x10\^9/L)
- measure
- Rates of acute GVHD (grade 2-4)
- timeFrame
- Day 100 post stem cell infusion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients undergoing an allogeneic HSCT from a sibling donor, as treatment for a hematological malignancy. The conditioning regimen, and in particular whether ablative or non ablative, will not be considered in the criteria for recruitment 2. Patient and donor Age \>18 years 3. Patients and donors must have signed an informed consent form 4. The donor must be willing and capable of donating lymphocytes for NK selection using apheresis techniques 5. Donor must be fit to undergo leukapheresis Exclusion Criteria: 1. Life expectancy \< 3 months 2. ECOG performance status 3 or 4 3. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, life threatening cardiac arrhythmia 4. Patients will not be eligible if they receive in vivo T depletion with ATG, ALG or campath-1H 5. HIV-positive patients 6. Psychiatric illness/social situations that would limit compliance with study requirements and ability to comprehend the investigational nature of the study and provide informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.