Prophylactic CD45RA-depleted DLI After Haploidentical Transplantation/RIC

University Hospitals (UH)

Status and phase

Enrolling

Phase 1

Conditions

Hematologic Malignancy

Haplo-identical Stem Cell Transplantation

Treatments

Other: CD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technology

Study type

Interventional

Funder types

Other

Identifiers

NCT05066412

Cd45RA depleted DLI

Details and patient eligibility

About

To assess safety of prophylactic escaladed dose of T naïve depleted (CD45RA depleted donor lymphocyte infusion, in patients with malignant hemopathie who received an allogeneic stem cell transplant from an haplo-identical donor, after a reduced intensity conditionning regiment.

Full description

Primary Objective is to determine whether the administration of prophylactic CD45RAneg (CD45RAneg) memory/effector T lymphocytes is feasible and safe in the early post-transplant period for patients with haploidentical transplant and RIC conditioning.

Donor lymphocytes are isolated from the original donor by non-mobilized mononuclear cell leukapheresis. Repetitive intravenous infusions (up to 3) of escalating doses of CD45RAneg cells, prepared from the leukapheresis by CliniMACS® technology (CD45RA-depletion), storage in vapor nitrogen.

Escalating doses of CD45RAneg cells, for patients with haploidentical graft, intervals of 6-8 weeks, if GvHD is absent starting ≥ 4 weeks from the day of transplantation.

Enrollment

12 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients who received a stem cell graft from a haploidentical donor after RIC for hematologic malignancies
Written informed consent of patient and donor obtained

Exclusion criteria

Participant taking Prednisone (or equivalent steroid)
Participant taking Prednisone (or equivalent steroid)
Participant taking Mycophenolate Mofetil
Participant taking Cyclosporine/tacrolimus at therapeutic blood levels
Progressive hematologic malignancy before transplant
Second allogeneic transplant
Acute GvHD ≥ grade 2
Chronic moderate or severe GvHD (NIH consensus criteria)
Hematologic or molecular relapse of the primary malignancy requiring chemotherapy or unmanipulated DLI (receiving prophylactic antileukemic agent, eg TKI, is not an exclusion criteria)
Donor aberrant CD45RA expression due to a polymorphism in CD45 gene
Participation in another interventional clinical trial within 30 days prior to inclusion
Pregnant or nursing women. Sexually active women with childbearing potential as well as sexually active male patients who are unwilling to use an effective method of contraception during participation in the study from time of inclusion until 2 months after last dose of CD45RAneg DLI infusion
Inability to follow the procedures of the study, including, but not limited to, language problems, psychological disorders, dementia