Single center Phase 1 dose escalation trial of the combination of standard-of-care
blinatumomab plus Haplo-Mismatched Cellular Therapy (HMCT). HMCT refers to the infusion of
donor peripheral blood mononuclear cells collected via pheresis from a haploidentical family
member - the procedure is analogous to giving a donor lymphocyte infusion outside of the
setting of an allogeneic stem cell transplant; also known as 'microtransplantation'. The HMCT
is an unselected mix of lymphocytes and leukocytes, but the product dose escalation will be
done based on the T cell content.
Ten recipients are planned. Each subject will be administered one infusion of HMCT during the
first cycle of blinatumomab and two infusions during cycle two of blinatumomab; the CD3+ cell
dose of the HMCT infusion is governed by dose escalation / de-escalation following a Bayesian
This single center, phase 1 study will examine the safety, side effects, and effectiveness of
combining the investigational use of Haplo-Mismatched Cellular Therapy (HMCT) in combination
with blinatumomab. Investigators plan to give HMCT starting on day 15, after the initial CRS
caused by blinatumomab has resolved. The investigational treatment will start with 1% of the
typical HMCT dose (10e6 CD3+ cells/kg) and will employ a modified dose escalation design as
an additional safety measure. The primary end points will be DLT of the combination of
blinatumomab and HMCT.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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