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LUMC-BOB1-B7-TCR.1 in relapsed and refractory B-cell malignancies
EU CTIS ID: 2024-515900-38-00
What this study is testing
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.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Pregnant or breast feeding women
- Known hypersensitivity against any drug of the mandatory trial procedures
- Has received vaccination with live vaccines 6 weeks prior to treatment
- 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
See the full eligibility criteria
- 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
- Pregnant or breast feeding women
- Known hypersensitivity against any drug of the mandatory trial procedures
- Has received vaccination with live vaccines 6 weeks prior to treatment
- 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
- Unwillingness or inability to comply with procedures required in this clinical trial protocol
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.