Blinatumomab Plus HLA-Mismatched Cellular Therapy for Relapsed/Refractory CD19+ ALL
Status:
Recruiting
Trial end date:
2024-02-01
Target enrollment:
Participant gender:
Summary
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
method.