PROTECT: ProTmune in Hematologic Malignancies

• Research type

  Research Study

• Full title

  PROTECT: A Phase 1, Non-Randomized, Open-Label/Phase 2, Randomized, Blinded Study of ProTmune™ (ex vivo Programmed Mobilized Peripheral Blood Cells) Versus Non-Programmed Mobilized Peripheral Blood Cells for Allogeneic Hematopoietic Cell Transplantation in Adult Subjects with Hematologic Malignancies

• IRAS ID

  202406

• Contact name

  James Griffin

• Contact email

  James.Griffin@UHBristol.nhs.uk

• Sponsor organisation

  Fate Therapeutics, Inc.

• Eudract number

  2016-001307-24

• Duration of Study in the UK

  3 years, 0 months, 0 days

• Research summary

  This is a Phase 1, non-randomised, open-label/Phase 2, randomised, blinded, multi-centre, open-label study of the ProTmune ex vivo programmed mobilised peripheral blood (mPB) cells versus non for allogeneic Hematopoietic Stem Cell Transplation (HCT) in adult subjects with blood cancers.

  This study consists of two consecutive phases, 1 and 2. Phase 1 will evaluate the safety of the ProTmune treatment on mobilised peripheral blood to be used in transplantation. Approximately six (6) to ten (10) patients will be enrolled and treated. After Phase 1 is completed, Phase 2 enrolment of approximately sixty (60) patients, randomly assigned to either ProTmune or Standard of care will start. Phase 2 will evaluate if ProTmune can prevent complications that frequently happen during transplantation, which include graft versus host disease (GvHD) and infections, specifically cytomegalovirus (CMV). Safety will also be evaluated.
  For patients with advanced blood cancers, allogeneic HCT is often the only therapeutic option that offers the potential to prolong lifespan or even a cure. Patients invited to take part in this study will be undergoing a mobilised peripheral blood transplant as treatment for cancer of the blood. Patient treated as part of this study will receive transplant preparation as per normal standard of care.

  ProTmune is an allogenic cell therapy product prepared from blood cells that are collected from a matched unrelated donor. After the collection, these cells are modified using special chemicals. The modification of the blood cells is the investigational part of the study. ProTmune is developed to prevent aGvHD and CMV infection. ProTmune has not been previously administered to patients and this is the first time this treatment has been tested in humans.
  Fate Therapeutics Inc, is sponsoring this study; approximately 70 patients (males and females aged 18 to 70 years) will be recruited into the study in the United Sates and Europe.

• REC name

  North East - York Research Ethics Committee

• REC reference

  17/NE/0008

• Date of REC Opinion

  13 Jan 2017

• REC opinion

  Unfavourable Opinion