T Lymphocytes (LT) Expressing iCASP9 and ΔCD19 in Allogeneic Haematopoietic Transplantation.

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the frequency of occurrence, severity, and response to treatment by a chemical agent, notably the dimerizer AP1903 (Bellicum Pharmaceuticals compagny), in the case of acute Graft versus Host Disease (aGvHD) occurring after the administration of T-lymphocytes expressing iCASP9 and concomitantly to a bone marrow graft depleted in B- and T-lymphocytes

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Besancon
• Collaborators: Bellicum Pharmaceuticals; Etablissement Français du Sang

Criteria

Inclusion Criteria:

• Adult patients aged ≤55 years (40< age ≤55 years);

• Patients who are candidates for myeloablative allogeneic bone marrow transplants: de novo or secondary acute lymphoblastic leukaemia (ALL) and acute myeloblastic leukaemia (AML) in complete remission (CR) ≥1; chronic myeloid leukaemia (CML) in chronic phase or in escape from tyrosine kinase inhibitors; myelodysplastic syndrome (MDS) with int-2 or high International Prognostic Scoring System (IPSS score, with medullary blastosis >10%); chemosensitive malignant non-Hodgkin's lymphoma (MNHL) in CR or partial remission (PR) >2 ; chemosensitive Hodgkin's disease in CR or PR >2 ; chemosensitive chronic lymphoid leukaemia (CLL) in CR or PR >2; chemosensitive myeloma in CR or PR ≥2;

• At high risk for GvHD: the risk for GvHD is considered high and the patient thus eligible for the study, if the receiver is >40 years, or if the donor is a woman and the receiver a man, regardless their age;

• Karnofsky index >70% or World Health Organization (WHO) index ≥2;

• Stable clinical conditions and life expectancy >3 months;

• Absence of organic disease contraindicating the transplantation

• Availability of a genotypically identical donor, aged >18 years, having given consent, and presenting no contraindications to bone marrow donation under general anaesthesia and to the required apheresis procedures;

• Written informed consent of the donor and patient.

Exclusion Criteria:

• Age <40 years or > 55 years

• Organic disease contraindicating the utilisation of myeloablative conditioning

• History of allogeneic Hematological Stem Cell Transplantation (HSCT);

• History of autologous HSCT <1 year prior to the date for the scheduled allogeneic HSCT;

• Neurological location of the haemopathy justifying the transplantation;

• Pregnant or breastfeeding woman;

• Positive HIV serology;

• Positive hepatitis B or hepatitis C serology (except for post-vaccinal hepatitis B status);

• Absence of informed consent from the receiver or donor;

• Inability to adhere to the protocol instructions.