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Evaluating ABBV-101 for treating B-cell malignancies

First-in-Human Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of the BTK Degrader, ABBV-101, in Participants With B-cell Malignancies

Phase 1 Interventional AbbVie · NCT05753501

This study is testing a new treatment called ABBV-101 to see if it can help adults with certain types of blood cancers, like non-Hodgkin's lymphoma and chronic lymphocytic leukemia, feel better and improve their condition.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment244 (estimated)
Ages18 Years and up
SexAll
SponsorAbbVie Industry-sponsored
Drugs / interventionsCAR-T, Chimeric antigen receptor
Locations44 sites (Tempe, Arizona and 43 other locations)
Trial IDNCT05753501 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety, pharmacokinetics, and preliminary efficacy of ABBV-101 in adult participants with relapsed or refractory non-Hodgkin's lymphomas and chronic lymphocytic leukemia. The study includes a dose escalation phase to determine the maximum administered dose and a dose expansion phase to evaluate changes in disease activity. Participants will be monitored for adverse events throughout the trial. The focus is on various B-cell malignancies, including diffuse large B-cell lymphoma and mantle cell lymphoma.

Who should consider this trial

Good fit: Ideal candidates are adults with relapsed or refractory B-cell malignancies who have undergone at least two prior lines of treatment.

Not a fit: Patients with early-stage B-cell malignancies or those who have not received prior treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat B-cell malignancies.

How similar studies have performed: Other studies have shown promise with similar investigational therapies targeting B-cell malignancies, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* For Dose Escalation (Part 1) only: Participants with documented diagnosis for one of the following 3L+ B-cell malignancies, from one of the following WHO-defined histologies (Swerdlow et al 2016):

  * Chronic lymphocytic leukemia (CLL)
  * Small lymphocytic lymphoma (SLL)
  * 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 2) only: Participants with documented diagnosis of CLL who are 3L+ including those with Bruton's tyrosine kinase (BTK) mutations or CAR-T/HCT R/R or ineligible non-GCB DLBCL who are 3L+ with histology based on criteria established by the World Health Organization (WHO).
* 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.
* Participants with prior central nervous system (CNS) disease that have been effectively treated may be eligible.

Exclusion Criteria:

* Previously treated with a Bruton's tyrosine kinase (BTK) degrader.
* Known active CNS disease, or primary CNS lymphoma.
* Uncontrolled active systemic infection, or active cytomegalovirus infection, known history of human immunodeficiency virus (HIV), active hepatitis B or C infection or less than 12 weeks since achieving undetectable viral load in cases of prior active hepatitis C.

Where this trial is running

Tempe, Arizona and 43 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hematologic CancerChronic lymphocytic leukemiaSmall lymphocytic lymphomaChimeric antigen receptor T-cellsHematopoietic cell transplantRelapsed/refractory or ineligible Diffuse large b-cell lymphomaMantle cell lymphomaFollicular lymphoma
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.