Phase
Condition
Lymphoproliferative Disorders
Marginal Zone Lymphoma
Leukemia
Treatment
ABBV-291
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
For dose escalation (Part 1) only: Participants must have documented diagnosis ofB-cell malignancies including (but not limited to) the following, with histologybased on criteria established by the World Health Organization (WHO), and measurabledisease requiring treatment:
Mantle cell lymphoma (MCL);
Marginal zone lymphoma (MZL);
Waldenstrom macroglobulinemia (WM);
Diffuse large b-cell lymphoma (DLBCL) (including: germinal center B-cell type,activated B-cell type, primary cutaneous DLBCL [leg type], Epstein-Barrvirus-positive (EBV+) DLBCL [not otherwise specified], DLBCL associated withchronic inflammation, human herpesvirus 8-positive [HHV8+] DLBCL [not otherwisespecified], B cell lymphoma [unclassifiable] with features intermediate betweenDLBCL and classical Hodgkin lymphoma, high-grade B-cell lymphoma [not otherwisespecified], high-grade B-cell lymphoma [with MYC (avian myelocytomatosis viraloncogene homolog) and BCL2 and/or BCL6 rearrangements], DLBCL arising fromfollicular lymphoma [FL] [transformed FL]);
FL Grades 1 to 3B;
For dose expansion (Part 2) only: Participants must have documented diagnosis of oneof the following B-cell malignancies, with histology based on criteria establishedby the WHO, and measurable disease requiring treatment:
Part 2a only: DLBCL (including: germinal center B-cell type, activated B-celltype, primary cutaneous DLBCL [leg type], EBV+ DLBCL [not otherwise specified],DLBCL associated with chronic inflammation, HHV8+ DLBCL [not otherwisespecified], B-cell lymphoma [unclassifiable] with features intermediate betweenDLBCL and classical Hodgkin lymphoma, high-grade B-cell lymphoma [not otherwisespecified], high-grade B-cell lymphoma [with MYC and BCL2 and/or BCL6rearrangements], DLBCL arising from FL [transformed FL]);
Part 2b only: FL Grades 1 to 3B;
Part 2c only: Mantle cell lymphoma;
For all participants (Parts 1 and 2):
Must be considered relapsed or refractory to, or intolerant of, at least 2 ormore prior lines of therapy known to provide a clinical benefit for theircondition, and for whom there is no appropriate locally available therapy knownto provide clinical benefit (e.g., standard chemotherapy or autologous stemcell transplantation [ASCT]).
Indolent non-Hodkin's lymphoma (NHL) participants must meet relevant diseasespecific requirements for treatment (e.g., National Comprehensive CancerNetwork [NCCN], Groupe d'Etude des Lymphomes Folliculaires [GELF]).
History of allogeneic stem cell transplantation must be stable off ofimmunosuppression for at least 3 months.
For participants enrolled in backfill cohorts or at dose levels previouslycleared, subjects must provide consent to an on-treatment fresh tumor biopsyfrom the same tumor lesion as the baseline tumor tissue. This requirement maybe waived at the discretion of the contract research organization (CRO) MedicalMonitor if collecting a biopsy would place the subject at risk of harm or wouldrequire a technically complicated procedure based on tumor location as assessedby the investigator or could hinder a subject's ability to participate in thestudy.
Previously treated with a CD79b-targeting therapy (e.g., CD79b monoclonalantibody) a core or excision tumor biopsy subsequent to the most recentCD79b-targeting therapy must be collected. Tumor biopsy requirements may bemodified by Sponsor during the study. This requirement may be waived at thediscretion of the contract research organization (CRO) Medical Monitor ifcollecting a biopsy would place the subject at risk of harm or would require atechnically complicated procedure based on tumor location as assessed by theinvestigator or could hinder a subject's ability to participate in the study.
CD79b expression status will be assessed in all participants.
Have an eastern cooperative oncology group (ECOG) Performance Status of 0 or 1.
Laboratory values meeting the criteria in the protocol within the screening periodprior to the first dose of study drug (if multiple samples are drawn within thescreening period, the sample/result immediately prior to Cycle 1 Day 1 isapplicable).
Availability of representative baseline tumor tissue (most recent archived tumortissue or fresh biopsy collected during screening phase) suitable forimmunohistochemistry (IHC) testing. This requirement may be waived at the discretionof the CRO Medical Monitor if collecting a biopsy at screening would place theparticipant at risk of harm or would require a technically complicated procedurebased on tumor location as assessed by the investigator or could hinder aparticipant's ability to participate in the study.
Exclusion
Exclusion Criteria:
History of interstitial lung disease (ILD) or pneumonitis that required treatmentwith systemic steroids, or any evidence of active ILD or pneumonitis.
Treatment with any of the following:
Anticancer therapy including chemotherapy, radiotherapy, small molecule,investigational, and biologic agents within 14 days (or at least 5 half-lives,whichever is shorter), prior to the first dose of the study treatment;
CD79b-directed agents (e.g., CD79b monoclonal antibody therapy) within 4 weeks (or at least 5 half-lives, whichever is shorter) prior to the first dose ofstudy treatment.
Prior treatment with an antibody drug conjugate that consists of atopoisomerase I inhibitor.
Study Design
Connect with a study center
St Vincent's Hospital Melbourne /ID# 261664
Fitzroy Melbourne, Victoria 2145234 3065
AustraliaActive - Recruiting
Sir Charles Gairdner Hospital /ID# 268579
Nedlands 2064874, Western Australia 2058645 6009
AustraliaActive - Recruiting
Hadassah Medical Center-Hebrew University /ID# 261658
Jerusalem 281184, Jerusalem 293198 91120
IsraelActive - Recruiting
Tel Aviv Sourasky Medical Center /ID# 261659
Tel Aviv 293397, Tel Aviv 293396 6423906
IsraelActive - Recruiting
Tel Aviv Sourasky Medical Center /ID# 261659
Tel Aviv, Tel-Aviv 6423906
IsraelSite Not Available
Hadassah Medical Center-Hebrew University /ID# 261658
Jerusalem, Yerushalayim 91120
IsraelSite Not Available
Aichi Cancer Center /ID# 267471
Nagoya-shi, Aichi 464-8681
JapanSite Not Available
Aichi Cancer Center /ID# 267471
Nagoya 1856057, Aichi-ken 1865694 464-8681
JapanActive - Recruiting
National Cancer Center Hospital East /ID# 261775
Kashiwa-shi, Chiba 2113014 277-8577
JapanActive - Recruiting
The Cancer Institute Hospital Of JFCR /ID# 267470
Koto-ku, Tokyo 1850144 135-8550
JapanActive - Recruiting
The Christie /ID# 267177
Manchester 2643123, M20 4BX
United KingdomActive - Recruiting
University Hospitals Plymouth NHS Trust /ID# 267174
Plymouth 2640194, PL6 5FP
United KingdomActive - Recruiting
Carolina BioOncology Institute /ID# 265259
Huntersville, North Carolina 28078
United StatesSite Not Available
Carolina BioOncology Institute /ID# 265259
Huntersville 4472370, North Carolina 4482348 28078
United StatesCompleted
Willamette Valley Cancer Institute and Research Center /ID# 270945
Eugene, Oregon 97401
United StatesSite Not Available
Willamette Valley Cancer Institute and Research Center /ID# 270945
Eugene 5725846, Oregon 5744337 97401
United StatesActive - Recruiting
Texas Oncology - Central/South Texas /ID# 270946
Austin, Texas 78705
United StatesSite Not Available
Texas Oncology - Central/South Texas /ID# 270946
Austin 4671654, Texas 4736286 78705
United StatesActive - Recruiting
START Mountain Region /ID# 267592
West Valley City, Utah 84119-3602
United StatesSite Not Available
START Mountain Region /ID# 267592
West Valley City 5784607, Utah 5549030 84119-3602
United StatesCompleted
Virginia Cancer Specialists - Fairfax /ID# 265082
Fairfax, Virginia 22031
United StatesSite Not Available
Virginia Cancer Specialists - Fairfax /ID# 265082
Fairfax 4758023, Virginia 6254928 22031
United StatesActive - Recruiting

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