This phase I trial is trying to understand how safe and tolerable a new targeted therapy (NKX019) is in people with relapsed or refractory non-Hodgkin lymphoma, chronic lymphocytic leukaemia or B-cell acute lymphoblastic leukaemia .
This trial is treating patients with large B cell lymphoma, mantle cell lymphoma, indolent lymphoma, Waldenström macroglobulinemiam, chronic lymphocytic leukaemia/small lymphocytic lymphoma, and B-cell acute lymphoblastic leukaemia.
This is a systemic therapy trial.
You may be able to join this trial if:
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You have had treatment, but your cancer has come back.
You may be excluded from this trial if:
- You have a certain disease or psychological condition.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.
Clinical Summary Read More
Use the hyperlinks, where available to access additional clinical trial information.
A Phase 1 Study of NKX019, a CD19 Chimeric Antigen Receptor Natural Killer (CAR NK) Cell Therapy, in Subjects With B-cell Malignancies
This is a dose-finding study that has two parts. In Part 1 (dose finding), a "3+3" enrolment schema will be utilised. In Part 2 (dose expansion), the safety and tolerability, cellular kinetics, pharmacodynamics and anti-tumour response will be further evaluated in expansion cohorts of participants with large B cell lymphoma (LBCL), mantle cell lymphoma (MCL), indolent lymphoma (IL), Waldenström macroglobulinemia (WM), CLL/ small lymphocytic lymphoma (SLL), and B-ALL. All subjects will receive fludarabine/cyclophosphamide lymphodepletion followed by 3 weekly doses of NKX019 on Day 0, 7, and 14 of a 28-day cycle. NKX019 is an investigational allogeneic CAR NK product targeting CD19 on cells. The starting dose of NKX019 in Part 1 is 3 × 10^8 NK cells (2 × 10^6/kg for patients < 50="" kg)="" administered="" as="" 3="" weekly="" doses.="" part="" 2="" will="" use="" the="" maximum="" tolerated="" dose="" (mtd)="" or="" recommended="" phase="" 2="" dose="" (rp2d)="" of="" nkx019="" as="" determined="" in="" part="">
Recruiting Hospitals Read More