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A Phase 2, Open-Label, Multicenter, Basket Study Evaluating the Safety and Efficacy of Brexucabtagene Autoleucel in Adults with Rare B-cell Malignancies (ZUMA-25) – Substudy A – Relapsed/Refractory Waldenstrom Macroglobulinemia (WM)
EU CTIS ID: 2022-501259-10-00
What this study is testing
The primary objective of ZUMA-25 is to evaluate the efficacy of brexucabtagene autoleucel in subjects with rare B-cell malignancies, by determining the Response Rates as defined within the substudies by central assessment. The primary objective of ZUMA-25 substudy A is to evaluate the efficacy of brexucabtagene autoleucel in WM by determining the combined rate of complete response (CR) and very good partial response (VGPR) by central assessment per the Sixth International Workshop in WM {Owen 2013}
- Therapeutic exploratory (Phase II)
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
- •Male or female 18 years of age or older at the time of signing the informed consent
- • Measurable disease, defined as presence of serum immunoglobulin (Ig) M with a minimum IgM level of > 2 times the upper limit of normal of each institution is required.
- • The inclusion criteria concerning washout periods prior to leukapheresis in the KT US 568-0138 master protocol must be met, with the exception that ibrutinib may be continued through leukapheresis and up to 5 half-lives (30 hours) prior to the start of lymphodepletion
- •Presence of toxicities due to prior therapy must be stable and recovered to Grade 1 or lower
- •ECOG performance status score of 0 or 1.
- •Adequate hematologic and end-organ function.
You likely can't join if
- • Prior CAR therapy or treatment with any anti-CD19 therapy
- • HIV-positive patients, unless taking appropriate anti-HIV medications, having an undetectable viral load by quantitative polymerase chain reaction (qPCR) and a CD4 count > 200 cells/uL.
- • History or presence of detectable cerebrospinal fluid malignant cells or brain metastases, with the exception of prior CNS disease in WM
- • History of autoimmune disease (eg, Crohn’s disease, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years.
- • History of allogeneic stem cell transplantation. A prior autologous stem cell transplantation is allowed, but at least 6 months should have elapsed
- • Plasmapheresis for symptomatic hyperviscosity or serum IgM > 5,000 mg/dL < 35 days prior to the screening IgM assessment
See the full eligibility criteria
- •Male or female 18 years of age or older at the time of signing the informed consent
- • Measurable disease, defined as presence of serum immunoglobulin (Ig) M with a minimum IgM level of > 2 times the upper limit of normal of each institution is required.
- • The inclusion criteria concerning washout periods prior to leukapheresis in the KT US 568-0138 master protocol must be met, with the exception that ibrutinib may be continued through leukapheresis and up to 5 half-lives (30 hours) prior to the start of lymphodepletion
- •Presence of toxicities due to prior therapy must be stable and recovered to Grade 1 or lower
- •ECOG performance status score of 0 or 1.
- •Adequate hematologic and end-organ function.
- •Participants of childbearing potential who engage in heterosexual intercourse must agree to use specified method(s) of contraception
- •Confirmed clinicopathological diagnosis of WM in accordance with the consensus panel of the Second International Workshop on WM (see Section 12.3.2)
- •Relapsed or refractory disease after 2 or more lines of therapy
- oPrior therapy must have included a BTK inhibitor. Also, chemotherapy and/or a proteasome inhibitor must have been attempted, with either subsequent documented disease progression or no response (stable disease)
- • Requiring treatment as defined in the recommendations from the Second International Workshop on WM
- • Prior CAR therapy or treatment with any anti-CD19 therapy
- • HIV-positive patients, unless taking appropriate anti-HIV medications, having an undetectable viral load by quantitative polymerase chain reaction (qPCR) and a CD4 count > 200 cells/uL.
- • History or presence of detectable cerebrospinal fluid malignant cells or brain metastases, with the exception of prior CNS disease in WM
- • History of autoimmune disease (eg, Crohn’s disease, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years.
- • History of allogeneic stem cell transplantation. A prior autologous stem cell transplantation is allowed, but at least 6 months should have elapsed
- • Plasmapheresis for symptomatic hyperviscosity or serum IgM > 5,000 mg/dL < 35 days prior to the screening IgM assessment
- • Exclusion of IgM monoclonal gammopathy of undetermined significance or IgM multiple myeloma
- • Presence of a central nervous system involvement (Bing-Neel syndrome). Subjects with a prior history of Bing-Neel syndrome are eligible if they show a negative cerebrospinal fluid and no involvement by imaging
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
- Canada
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States; Canada. Enter your location above to see the nearest site and check your eligibility.
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.