Abatacept Mediated Natural Killer Cell-Based Immunotherapy
- Conditions
- Health Condition 1: D759- Disease of blood and blood-formingorgans, unspecified
- Registration Number
- CTRI/2021/09/036713
- Lead Sponsor
- Manashi Chakrabarti Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
· First allogeneic transplant.
· Age between 2 and 65 years.
· Patients must have a related donor that is HLA-matched at least 5 of 10 HLA A, B, C, DRB1, DQB.
· Cardiac function: Shortening fraction >25%; ejection fraction >40%
· Estimated creatinine clearance greater than 50 mL/minute
· Pulmonary function: DLCO >=40% (adjusted for hemoglobin) and FEV1>=70%, oxygen saturation >91%
· Liver function: direct (conjugated) bilirubin < 2x the upper limit of normal and ALT/AST < 2.5x the upper normal limit
· No major organ disfunction
· Signed informed consent
· Life expectancy less than 6 months
· Patients with uncontrolled bacterial, viral or fungal infections (undergoing appropriate treatment and with progression of clinical symptoms) within 1 month prior to conditioning. Patients with febrile illness or suspected minor infection should await clinical resolution prior to starting conditioning.
· Pregnant or breastfeeding patients
· Patients seropositive for the human immunodeficiency virus (HIV)
· Patient with active Hepatitis B or C determined by serology and/or NAAT not on treatment
· Active hepatitis, bridging fibrosis or cirrhosis on liver biopsy (biopsy required for patients on chronic transfusion therapy for > 1 year and evidence of iron overload with ferritin >1000 ng/mL)
· Patients with suitable 10/10 HLA matched related and unrelated donors
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The potential of CTLA4Ig in sparing and/or potentiating NK cell cytotoxicity is an unexplored and yet an exciting possibility in the field of cellular therapy with initial clinical data strongly suggesting a favourable impact of the molecule on NK cell function. This study will help in establishment of the mechanistic pathway underlying this phenomenon. <br/ ><br>The exploration of the crosstalk between NK cells and monocyte/macrophages might uncover hitherto unknown pathways by which anti-leukemia activity of NK cells is potentiated. <br/ ><br>Timepoint: 24 months
- Secondary Outcome Measures
Name Time Method The translational impact of unraveling the interaction between NK cells and monocyte/macrophages on exposure to CTLA4Ig might have a far-reaching impact in the field of cellular therapy, wherein a unique and more importantly, an affordable scalable platform for NK cell-based immunotherapy could be established, both in the context of HCT and without HCT.Timepoint: 24 months