LUMC-BOB1-B7-TCR.1 for B-cell acute lymphoblastic leukemia | Multiple myeloma | Non-Hodgkin B-cell lymphoma

Inclusion criteria

• {"criterion_text":"- 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\n- Eastern Cooperative Oncology Group (ECOG) performance status 0-3\n- Negative pregnancy test in women of childbearing potential\n- For fertile men and women, agreement to use highly effective contraceptive methods for the period between screening and 12 months after IMP infusion\n- Disease entity specific inclusion criteria as specified in the trial protocol\n- Age ≥ 18 years\n- Patients must be able to understand and be willing to give signed informed consent\n- Positive for HLA-B*07:02 according to genotyping results\n- 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)\n- No treatment with other investigational therapeutic product within 3 months prior to IMP infusion\n- 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\n- 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 criteria

• {"criterion_text":"- Pregnant or breast feeding women\n- Known hypersensitivity against any drug of the mandatory trial procedures\n- Has received vaccination with live vaccines 6 weeks prior to treatment\n- Active infection with HIV, HBV, HCV or HTLV 1/2\n- Active cerebral localization of B-cell malignancy (cerebral involvement in the past is allowed)\n- Active Graft versus Host Disease requiring current immunosuppression\n- 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\n- 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\n- Unwillingness or inability to comply with procedures required in this clinical trial protocol\n- Uncontrolled central nervous system disease\n- 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"}

Primary endpoints

• {"endpoint_text":"- Phase 1: The proportion of manufacturing runs from which a LUMCBOB1-B7-TCR.1 drug product was generated at the intended dose.","definition_or_measurement_approach":"Proportion of manufacturing runs that successfully generated the drug product at the intended dose (manufacturing yield/success rate)."}
• {"endpoint_text":"- Phase 1: The proportion of included patients that received LUMC-BOB1- B7-TCR.1 treatment.","definition_or_measurement_approach":"Proportion of enrolled patients who proceeded to receive the IMP infusion."}
• {"endpoint_text":"- Phase 1: The rate of dose-limiting toxicities (DLTs) within a specific dose cohort until 28 days after LUMC-BOB1-B7-TCR.1 infusion.","definition_or_measurement_approach":"Rate of DLTs observed in each dose cohort, assessed up to 28 days post-infusion."}
• {"endpoint_text":"- Phase 1: The maximum tolerated dose evaluated by Bayesian Dose Interval (BOIN) design with a target toxicity rate of 0.3, which is defined as the rate of DLTs within a dose cohort until 28 days after LUMC-BOB1-B7- TCR.1 infusion.","definition_or_measurement_approach":"Maximum tolerated dose determined using a BOIN (Bayesian Dose Interval) design targeting a toxicity rate of 0.3; DLT rate defined as occurrences within 28 days post-infusion."}
• {"endpoint_text":"- Phase 1: The recommended dose for patient treatment in phase 2.","definition_or_measurement_approach":"Dose selected based on safety, DLTs, and BOIN dose-escalation outcomes to be recommended for phase 2."}
• {"endpoint_text":"- Phase 2: Safety and toxicity assessment of LUMC-BOB1-B7-TCR.1 treatment per (serious) adverse event (AE) up to 2 years after infusion, reported according to ASTCT and CTCAE.","definition_or_measurement_approach":"Assessment of (serious) AEs up to 2 years post-infusion, reported and graded using ASTCT and CTCAE criteria."}
• {"endpoint_text":"- Phase 2: Response rate 12 weeks after infusion, response is defined as absence of circulating B cells and/or best objective response as defined in literature.","definition_or_measurement_approach":"Response rate measured at 12 weeks post-infusion; response defined as absence of circulating B cells and/or best objective response per literature definitions."}

Netherlands

Earliest CTIS Part Ii Submission Date

25-05-2025

Latest Decision Or Authorization Date

09-02-2026

Processing Time Days

260

Number Of Sites

1

Number Of Participants

22

Primary sponsor

Full Name

Leids Universitair Medisch Centrum (LUMC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands