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Clinical Trials/2022-501259-10-00
2022-501259-10-00
Completed
Phase 2

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

Kite Pharma Inc.18 sites in 7 countries37 target enrollmentStarted: February 13, 2023Last updated:
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Interventions-

Overview

Phase
Phase 2
Status
Completed
Enrollment
37
Locations
18
Primary Endpoint
The primary endpoint of ZUMA-25 as per the master protocol is response rates by central assessment as defined in each substudy. The primary end point of Substudy A (WM) is combined rate of CR and VGPR rate by central assessment defined as the proportion of subjects who achieve either CR or VGPR .
OverviewEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

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}

Eligibility Criteria

Ages
18 years to 65+ years (18-64 Years, 65+ Years)
Accepts Healthy Volunteers
Yes

Inclusion 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
  • •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)

Exclusion Criteria

  • •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

Arms & Interventions

-

Auxiliary

Participants receiving -

Intervention: - (Drug)

Outcomes

Primary Outcomes

The primary endpoint of ZUMA-25 as per the master protocol is response rates by central assessment as defined in each substudy. The primary end point of Substudy A (WM) is combined rate of CR and VGPR rate by central assessment defined as the proportion of subjects who achieve either CR or VGPR .

The primary endpoint of ZUMA-25 as per the master protocol is response rates by central assessment as defined in each substudy. The primary end point of Substudy A (WM) is combined rate of CR and VGPR rate by central assessment defined as the proportion of subjects who achieve either CR or VGPR .

Secondary Outcomes

  • The secondary endpoints of ZUMA-25 as per the master protocol are: • CR rate by central assessment as defined in each substudy
  • • Duration of Response
  • • Overall Survival
  • • Progression-free survival
  • • Time to next treatment defined as the time from enrollment (for Full Analysis Set [FAS]) or brexucabtagene autoleucel infusion (for modified intention to treat [mITT]) to the initiation of subsequent anticancer therapy/treatment
  • • Time to first response from brexucabtagene autoleucel infusion to the first response as defined in the substudy
  • Substudy A (WM) specific secondary endpoints are: •ORR, defined as the proportion of subjects who achieve a best response of CR, VGPR, or partial response (PR)
  • • Combined CR and VGPR rate by investigator assessment defined as the proportion of subjects who achieve either CR or VGPR
  • • Rate of VGPR and PR, separately

Investigators

Sponsor Class
Pharmaceutical company
Responsible Party
Principal Investigator
Principal Investigator

EU Clinical Trials Support

Scientific

Kite Pharma Inc.

Study Sites (18)

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