LUMC-BOB1-B7-TCR.1 in relapsed and refractory B-cell malignancies

Trial details

Who runs it

Leids Universitair Medisch Centrum (LUMC)

Trial code

EU 2024-515900-38-00

Record updated

2026. február 9.

Original description

The objective of this trial is to determine feasibility, safety and efficacy of LUMC-BOB1-B7-TCR.1 treatment in patients positive for Human Leukocyte Antigen (HLA)-B*07:02 with relapsed or refractory B-cell malignancies.Read full original descriptionShow less

BOB1-TCR therapy for treatment of relapsed or refractory B-cell malignancies - A Phase 1/2 clinical trial

The objective of this trial is to determine feasibility, safety and efficacy of LUMC-BOB1-B7-TCR.1 treatment in patients positive for Human Leukocyte Antigen (HLA)-B*07:02 with relapsed or refractory B-cell malignancies.

Inclusion: Disease persistence or progression of B-cell Acute Lymphoblastic Leukemia (B-ALL), Multiple Myeloma (MM) or non-Hodgkin B-cell lymphoma without standard treatment options as judged by the treating clinician and by a board of at least two other hematologists of the LUMC; Eastern Cooperative Oncology Group (ECOG) performance status 0-3; Negative pregnancy test in women of childbearing potential; For fertile men and women, agreement to use highly effective contraceptive methods for the period between screening and 12 months after IMP infusion; Disease entity specific inclusion criteria as specified in the trial protocol; Age ≥ 18 years; Patients must be able to understand and be willing to give signed informed consent; Positive for HLA-B*07:02 according to genotyping results; Reliable source of autologous CD8 T cells must be available: o At least 0.03 x 109 CD8+ T cells/L in PB or, alternatively, o Cryopreserved leukapheresis material available that meets all qualification prerequisites as defined by the investigational medicinal product dossier (IMPD); No treatment with other investigational therapeutic product within 3 months prior to IMP infusion; No treatment with T-cell engaging bispecific antibodies (BsAbs) within 6 months prior to leukapheresis or, alternatively, no treatment with BsAbs within 2 months prior to the projected date of IMP infusion and availability of cryopreserved leukapheresis material for IMP manufacture harvested prior to start of BsAb treatment; In patients with prior Chimeric Antigen Receptor (CAR) therapy: no CAR therapy within 6 months prior to leukapheresis and CAR T cells in PB below limit of detection or, alternatively, availability of cryopreserved leukapheresis material harvested prior to CAR therapy and no CAR therapy within 3 months prior to IMP infusion.

Exclusion: Has received vaccination with live vaccines 6 weeks prior to treatment; Known hypersensitivity against any drug of the mandatory trial procedures; Active infection with HIV, HBV, HCV or HTLV 1/2; Active cerebral localization of B-cell malignancy (cerebral involvement in the past is allowed); Active Graft versus Host Disease requiring current immunosuppression; Any clinically significant, advanced or unstable disease or inadequate main organ function that may put the patient at increased risk for severe complications of trial participation at the discretion of the investigator; Use of systemic immune suppression including, but not limited to: immunosuppressive agents such as cyclosporine or corticosteroids (at an equivalent dose of 0.5 mg prednisone/kg body weight per day, or higher), inhaled corticosteroids and physiological replacement for adrenal insufficiency are allowed; Uncontrolled central nervous system disease; Uncontrolled life-threatening infections or uncontrolled disseminated intravascular coagulation; however, if these problems resolve, the start of IMP production and treatment can be initiated on a delayed schedule; Pregnant or breast feeding women; Unwillingness or inability to comply with procedures required in this clinical trial protocol.

EU CTIS 2024-515900-38-00