Study to Evaluate Adverse Events, Change in Disease Activity, and How Oral ABBV-101 Moves Through the Body in Adult Participants With B-Cell Malignancies

Running, not enrolling · Phase 1

Conditions studied: Hematologic Cancer

In brief

Non-Hodgkin's lymphoma (NHL) is a cancer that arises from the transformation of normal B and T lymphocytes (white blood cells). The purpose of this study is to assess the safety, pharmacokinetics, and preliminary efficacy of ABBV-101 in adult participants in relapsed or refractory (R/R) non-Hodgkin's lymphomas: chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), diffuse large b-cell lymphoma (DLBCL), non-germinal center B cell (GCB) DLBCL, mantle cell lymphoma (MCL), follicular lymphoma (FL), marginal zone lymphoma (MZL), Waldenström macroglobulinemia (WM), or transformed indolent NHL. Adverse events will be assessed. ABBV-101 is an investigational drug being developed for the treatment of NHL. This study will include a dose escalation phase to determine the maximum administered dose (MAD)/Maximum tolerated dose (MTD) of ABBV-101. Dose expansion part 2A will follow to further determine the safety and change in disease activity in participants with first line treatment (1L\[non-US only\]), second line or later of treatment (2L)+ CLL/SLL or third line or later of treatment (3L+) non-GCB DLBCL receiving ABBV-101 alone. Dose expansion Part 2B (non-US only) will follow to determine the safety and change in disease activity in participants with 1L or 2L+ CLL/SLL receiving ABBV-101 in combination with oral venetoclax. Approximately 390 adult participants with multiple NHL subtypes will be enrolled in the study in sites world wide. In the dose escalation phase of the study participants will receive escalating oral doses of ABBV-101, until the MAD/MTD is determined, as part of the approximately 100 month study duration. In the dose expansion phase of the study participants receive oral ABBV-101 alone or oral ABBV-101 at a dose determined in the dose escalation phase in combination with oral venetoclax, as part of the approximately 100 month study duration. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, and side effects.

Key facts

Study ID: NCT05753501
Run by: AbbVie
People needed: 135
Starts: 2023-06-09
Expected to finish: 2031-03-01
Last updated by the study team: 2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

For Dose Escalation (Part 1) only (including backfill): Participants have received at least two prior systemic therapies, have no available therapies known to provide clinical benefit (e.g., standard chemotherapy or HCT), have measurable disease requiring treatment, and have a documented diagnosis for one of the following third line or later B-cell malignancies, from one of the following world health organization (WHO)-defined histologies (Swerdlow et al 2016):
Chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)
For Dose Escalation (Part 1) backfill only - Bruton's tyrosine kinase inhibitor (BTKi)/Bruton's tyrosine kinase degrader (BTKd)-naïve CLL/SLL. Participants with a documented diagnosis of CLL/SLL who have received at least one prior systemic therapy that cannot be a BTK inhibitor or degrader, and, with the exception of BTK pathway agents, have no available therapies known to provide clinical benefit (e.g., standard chemotherapy or HCT), and have measurable disease requiring treatment.
For Dose Escalation (Part 1) backfill only - BTKi/BCL-2i combination regimen-exposed 2L CLL/SLL. Participants with a documented diagnosis of CLL/SLL who have received one prior systemic therapy with a BTKi and BCL-2i combination regimen, have no available therapies known to provide clinical benefit (e.g., standard chemotherapy or HCT), and have measurable disease requiring treatment.
Chimeric antigen receptor T-cells (CAR-T)/hematopoietic cell transplant (HCT) relapsed/refractory (R/R) or ineligible diffuse large b-cell lymphoma (DLBCL) from the following histologies: DLBCL not otherwise specified (NOS) (germinal center B cell [GCB] and non-GCB DLBCL), T-cell/histiocyte-rich large B-cell lymphoma, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, anaplastic lymphoma kinase positive (ALK+) large B-cell lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and high-grade B-cell lymphoma NOS.
Mantle cell lymphoma (MCL)
Follicular lymphoma [FL] (grades 1-3b)
Marginal zone lymphoma [MZL] (splenic, extranodal, and nodal)
Waldenström macroglobulinemia (WM)
Transformed indolent non-Hodgkin's lymphoma (iNHL)
For Dose Expansion (Part 2a) CLL/SLL only: Participants with a documented diagnosis of CLL/SLL in their first-line or later treatment.
For Dose Expansion (Part 2a) DLBCL only: Participants have received at least two prior systemic therapies, have no available therapies known to provide clinical benefit (e.g., standard chemotherapy or HCT), have measurable disease requiring treatment, and have documented diagnosis of CAR-T/HCT R/R or ineligible non-GCB DLBCL who are in their third line or later treatment with histology based on criteria established by the WHO.
For Dose Exploration of ABBV-101 combination with venetoclax (Part 2b) CLL/SLL only: Participants with a documented diagnosis of CLL/SLL in their first-line or later treatment: In safety lead-in for each dose level, participants must have received at least one prior systemic therapy.
Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2. For EU only: Participant has an ECOG PS of 0 or 1.
Participant has a life expectancy >= 12 weeks.
Prior Bruton's tyrosine kinase inhibitor (BTKi) is allowed.
Adequate hematologic, renal, and hepatic function per the protocol.

You may not qualify if…

Previously treated with a Bruton's tyrosine kinase (BTK) degrader.
Known active central nervous system (CNS) disease, or primary CNS lymphoma. Participants with prior CNS disease that have been effectively treated may be eligible.
Uncontrolled active systemic infection requiring systemic treatment that is ongoing or was completed <= 14 days before the first dose of study drug, or active cytomegalovirus infection.

Where it is running

UC Irvine Medical Center /ID# 263020 — Orange, California, United States
Stanford University - Palo Alto /ID# 249683 — Palo Alto, California, United States
Rocky Mountain Cancer Centers - Lone Tree /ID# 252237 — Lone Tree, Colorado, United States
Northwestern University Feinberg School of Medicine /ID# 249347 — Chicago, Illinois, United States
Beth Israel Deaconess Medical Center /ID# 249302 — Boston, Massachusetts, United States
Rutgers Cancer Institute of New Jersey /ID# 249323 — New Brunswick, New Jersey, United States
New York Oncology Hematology - Albany Cancer Center /ID# 252240 — Albany, New York, United States
Northwell Health - Monter Cancer Center /ID# 250422 — Lake Success, New York, United States
University of Rochester Medical Center /ID# 249324 — Rochester, New York, United States
UC Health - Cincinnati /ID# 249299 — Cincinnati, Ohio, United States
Oncology Assoc. of Oregon PC - WVCI and Research Ctr - Springfield /ID# 249309 — Eugene, Oregon, United States
University of Pennsylvania /ID# 250341 — Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center /ID# 249293 — Houston, Texas, United States
University Health Network_Princess Margaret Cancer Centre /ID# 253483 — Toronto, Ontario, Canada
CHUM Notre-Dame Hospital /ID# 253428 — Montreal, Quebec, Canada
Institut Bergonie /ID# 253664 — Bordeaux, Gironde, France
CHU Montpellier - Hopital Saint Eloi /ID# 253666 — Montpellier, Herault, France
CHRU Lille - Hopital Claude Huriez /ID# 253665 — Lille, Nord, France
Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 256248 — Nantes, Pays de la Loire Region, France
Institut Gustave Roussy /ID# 253662 — Villejuif, Val-de-Marne, France
Hopital Saint-Louis /ID# 253663 — Paris, France
Universitaetsklinikum Ulm /ID# 253742 — Ulm, Baden-Wurttemberg, Germany
Universitaetsklinikum Wuerzburg /ID# 254636 — Würzburg, Bavaria, Germany
Universitaetsmedizin Rostock /ID# 259657 — Rostock, Mecklenburg-Vorpommern, Germany
Arizona Oncology - Tucson - Wilmot Road /ID# 252351 — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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