B7.1/IL-2 Leukaemia Cell Vaccine forNon-Transplant AML
Research type
Research Study
Full title
Phase I Study Of B7.1 (CD80) / IL-2 Immune Gene Therapy For Patients With Acute Myeloid Leukaemia, Unable To Undergo Bone Marrow Transplantation And At Risk Of Relapse
IRAS ID
120420
Contact name
GHULAM J MUFTI
Contact email
Eudract number
2012-005163-28
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
Acute Myeloid Leukaemia (AML) is an abnormal growth of myeloid cells (blasts) in the blood and bone marrow, predominantly affecting people over the age of 60. Current treatment is chemotherapy to normalise the number of blasts (complete remission), in some cases followed by haematopoietic stem cell transplantation to replace the patient’s damaged immune system. Relapse risk following treatment varies between patients, dictating whether or not transplantation, the only known long-term functional cure, is a therapeutic option. Although advances in reduced toxicity drugs have expanded transplantation feasibility many older patients, and individuals with comorbidities, are still unable to tolerate the transplantation procedure or related complications. Consequently a considerable proportion of patients with AML have only chemotherapeutic options available, which usually fail to prevent relapse, representing an unmet clinical need. Immunotherapy using a whole cell leukemia vaccine is proposed to address this, providing tolerable, low toxicity, effective induction of long-term disease control, augmenting the patient’s immune system to target residual leukaemia cells.
The patient-specific AML cell vaccine is derived from leukemic cells, modified to stimulate an effective anti-leukemia immune response. A concurrent clinical trial reports that the vaccine has been well tolerated to date in two patients experiencing relapse post-transplantation. In this Phase I clinical study the AML cell vaccine will be administered to 10 patients experiencing AML relapse, who are able to receive standard chemotherapy, but unable to tolerate transplantation. A minimum of 3 vaccine doses (maximum 10) will be administered at defined intervals, with safety, efficacy and immune responses monitored. The study will be performed over a maximum of 30 weeks with 28 weeks follow-up, at King’s College Hospital; a leading international blood cancer centre, and largest bone marrow transplantation programme in the UK, and King’s College London; the site of AML cell vaccine development, manufacture, and safety and efficacy assessments.REC name
South Central - Oxford A Research Ethics Committee
REC reference
13/SC/0492
Date of REC Opinion
11 Nov 2013
REC opinion
Further Information Favourable Opinion