Rivogenlecleucel

Unassigned

New Medicines

Rivo-cel · Primary immunodeficiency and other haematological non-malignant diseases in children and young people undergoing haploidentical haematopoietic stem cell transplant - adjunctive therapy

Information

Rivo-cel
New molecular entity
Bellicum
Bellicum

Development and Regulatory status

Phase II Clinical Trials
Phase II Clinical Trials
Phase II Clinical Trials
Yes
Yes

Category

A genetically modified donor T-cell product. Donor T-lymphocytes are modified with a retroviral vector (BPZ1001) and engineered to express the iCasp9 protein, which acts a “safetyswitch” in the event of graft versus host disease.
Registry data from the British Society of Blood and Marrow Transplantation shows that in 2015–2017 there were between 23 and 40 paediatric haploidentical HSCTs per year. After HSCT treatment it can take six to twelve months blood cell levels and immune cell functions to become near-normal. During this time there is a high rate of transplant rejection, graft versus host disease (GvHD), disease relapse and transplant-related mortality [1].
Primary immunodeficiency and other haematological non-malignant diseases in children and young people undergoing haploidentical haematopoietic stem cell transplant - adjunctive therapy
Intravenous infusion

Further information

Yes
To be confirmed

Evidence based evaluations

Rivo-cel · Haematological malignancies in patients undergoing haploidentical haematopoietic stem cell transplant - adjunctive therapy

Information

Rivo-cel
New molecular entity
Bellicum
Bellicum

Development and Regulatory status

Phase II Clinical Trials
Phase II Clinical Trials
Phase III Clinical Trials
Yes
Yes

Category

A genetically modified donor T-cell product. Donor T-lymphocytes are modified with a retroviral vector (BPZ1001) and engineered to express the iCasp9 protein, which acts a “safetyswitch” in the event of graft versus host disease.
Registry data from the British Society of Blood and Marrow Transplantation shows that in 2015–2017 there were between 23 and 40 paediatric haploidentical HSCTs per year. After HSCT treatment it can take six to twelve months blood cell levels and immune cell functions to become near-normal. During this time there is a high rate of transplant rejection, graft versus host disease (GvHD), disease relapse and transplant-related mortality [1].
Haematological malignancies in patients undergoing haploidentical haematopoietic stem cell transplant - adjunctive therapy
Intravenous infusion

Further information

Yes
To be confirmed

Evidence based evaluations