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Hematologic CancerPhase 1NCT05753501

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

A Phase 1 study testing ABBV-101 and Venetoclax in people with Hematologic Cancer, run by AbbVie at 51 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hematologic Cancer
What is being tested?
ABBV-101 and Venetoclax
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
135 participants
Where
51 sitesin 9 countries
Study dates
9 Jun 2023to Mar 2031
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 17Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

51 sites in 9 countries.

51 sites in 9 countries

United States14 sites

  • New York Oncology Hematology - Albany Cancer Center /ID# 252240

    Albany, New York, 12206-5013

  • Beth Israel Deaconess Medical Center /ID# 249302

    Boston, Massachusetts, 02215-5400

  • Northwestern University Feinberg School of Medicine /ID# 249347

    Chicago, Illinois, 60611-2927

  • UC Health - Cincinnati /ID# 249299

    Cincinnati, Ohio, 45267-2800

  • Oncology Assoc. of Oregon PC - WVCI and Research Ctr - Springfield /ID# 249309

    Eugene, Oregon, 97401-6036

  • MD Anderson Cancer Center /ID# 249293

    Houston, Texas, 77030

  • Northwell Health - Monter Cancer Center /ID# 250422

    Lake Success, New York, 11042

  • Rocky Mountain Cancer Centers - Lone Tree /ID# 252237

    Lone Tree, Colorado, 80124

  • Rutgers Cancer Institute of New Jersey /ID# 249323

    New Brunswick, New Jersey, 08901

  • UC Irvine Medical Center /ID# 263020

    Orange, California, 92868-3201

  • Stanford University - Palo Alto /ID# 249683

    Palo Alto, California, 94304

  • University of Pennsylvania /ID# 250341

    Philadelphia, Pennsylvania, 19104

  • University of Rochester Medical Center /ID# 249324

    Rochester, New York, 14642-0001

  • Arizona Oncology - Tucson - Wilmot Road /ID# 252351

    Tucson, Arizona, 85711

Other trials in United States

France6 sites

  • Institut Bergonie /ID# 253664

    Bordeaux, Gironde, 33000

  • CHRU Lille - Hopital Claude Huriez /ID# 253665

    Lille, Nord, 59037

  • CHU Montpellier - Hopital Saint Eloi /ID# 253666

    Montpellier, Herault, 34295

  • Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 256248

    Nantes, Pays de la Loire Region, 44000

  • Hopital Saint-Louis /ID# 253663

    Paris, 75010

  • Institut Gustave Roussy /ID# 253662

    Villejuif, Val-de-Marne, 94805

Other trials in France

Germany6 sites

  • Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 257431

    Berlin, 12203

  • Universitaetsklinikum Hamburg-Eppendorf /ID# 264566

    Hamburg, 20246

  • Universitaetsklinikum des Saarlandes /ID# 257435

    Homburg, Saarland, 66424

  • Universitaetsmedizin Rostock /ID# 259657

    Rostock, Mecklenburg-Vorpommern, 18057

  • Universitaetsklinikum Ulm /ID# 253742

    Ulm, Baden-Wurttemberg, 89081

  • Universitaetsklinikum Wuerzburg /ID# 254636

    Würzburg, Bavaria, 97080

Other trials in Germany

Spain6 sites

  • Hospital Universitario Vall de Hebron /ID# 260447

    Barcelona, 08035

  • Hospital Universitario Ramon y Cajal /ID# 260450

    Madrid, 28034

  • Hospital Universitario Fundacion Jimenez Diaz /ID# 253654

    Madrid, 28040

  • Hospital Universitario HM Sanchinarro /ID# 253655

    Madrid, 28050

  • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 260196

    Majadahonda, Madrid, 28222

  • Hospital Universitario de Salamanca /ID# 253656

    Salamanca, 37711

Other trials in Spain

Italy5 sites

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII /ID# 260317

    Bergamo, 24127

  • IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 255172

    Bologna, 40138

  • IRCCS Ospedale San Raffaele /ID# 253531

    Milan, Milano, 20132

  • ASST Grande Ospedale Metropolitano Niguarda /ID# 253532

    Milan, Milano, 20162

  • A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 253530

    Turin, Piedmont, 10126

Other trials in Italy

Israel4 sites

  • Hadassah Medical Center-Hebrew University /ID# 251123

    Jerusalem, Jerusalem, 91120

  • The Chaim Sheba Medical Center /ID# 251122

    Ramat Gan, Tel Aviv, 5265601

  • Tel Aviv Sourasky Medical Center /ID# 259608

    Tel Aviv, Tel Aviv, 6423906

  • Yitzhak Shamir Medical Center /ID# 254566

    Ẕerifin, Central District, 70300

Other trials in Israel

Japan4 sites

  • National Cancer Center Hospital /ID# 250680

    Chuo-ku, Tokyo, 104-0045

  • National Cancer Center Hospital East /ID# 250684

    Kashiwa-shi, Chiba, 277-8577

  • The Cancer Institute Hospital Of JFCR /ID# 260375

    Koto-ku, Tokyo, 135-8550

  • Kyoto University Hospital /ID# 261837

    Kyoto, Kyoto, 606-8507

Other trials in Japan

United Kingdom4 sites

  • Addenbrookes Hospital /ID# 256242

    Cambridge, Cambridgeshire, CB2 2QQ

  • Leicester Royal Infirmary /ID# 255171

    Leicester, England, LE1 5WW

  • University College London Hospital /ID# 260202

    London, Greater London, NW1 2BU

  • Kings College Hospital NHS Foundation Trust /ID# 253670

    London, Greater London, SE5 9RS

Other trials in United Kingdom

Canada2 sites

  • CHUM Notre-Dame Hospital /ID# 253428

    Montreal, Quebec, H2L 4M1

  • University Health Network_Princess Margaret Cancer Centre /ID# 253483

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

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

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.

Read more

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.

Being tested
ABBV-101, Venetoclax
Keywords
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), Mantle cell lymphoma (MCL), Follicular lymphoma (FL), Marginal zone lymphoma (MZL), Waldenström macroglobulinemia (WM), Transformed Indolent non-Hodgkin's lymphoma (INHL), Hematologic Cancer, ABBV-101
Medical subject headings
Hematologic Neoplasms, Leukemia, Lymphocytic, Chronic, B-Cell, Recurrence, Lymphoma, Mantle-Cell, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Waldenstrom Macroglobulinemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05753501
Study groupRoleWhat they receive
Part 1: Dose Escalation ABBV-101ExperimentalParticipants with relapsed or refractory (R/R) Non-Hodgkin's lymphoma (NHL) will receive escalating doses of ABBV-101, until the maximum administered dose (MAD)/Maximum tolerated dose (MTD) is determined, as part of the approximately 100 month study duration.
Receives: Drug: ABBV-101
Part 2A: Dose Expansion ABBV-101 R/R & Treatment-Naive CLL/SLLExperimentalParticipants with R/R and treatment-naive chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) will receive ABBV-101 at the dose determined in the dose escalation arm, as part of the approximately 100 month study duration.
Receives: Drug: ABBV-101
Part 2A: Dose Expansion ABBV-101 R/R non-GCB DLBCLExperimentalParticipants with R/R non-germinal center B cell (GCB) diffuse large B-cell lymphoma (DLBCL) will receive ABBV-101 at the dose determined in the dose escalation arm, as part of the approximately 100 month study duration.
Receives: Drug: ABBV-101
Part 2B: Dose Expansion ABBV-101 + Venetoclax in CLL/SLLExperimentalParticipants with R/R and treatment-naive CLL/SLL will receive ABBV-101 at the dose determined in the dose escalation arm in combination with venetoclax, as part of the approximately 100 month study duration.
Receives: Drug: ABBV-101; Drug: Venetoclax

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Adverse Events (AE)

    AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

    Measured: Up to Approximately 100 Months

  2. Change in Laboratory Parameters

    Number of participants with clinically significant change from baseline in clinical laboratory test results like hematology will be reported.

    Measured: Up to Approximately Two Years

  3. Change in Vital Signs

    Number of participants with clinically significant change from baseline in vital signs like systolic and diastolic blood pressure will be reported.

    Measured: Up to Approximately Two Years

  4. Change in Electrocardiogram (ECG)

    12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.

    Measured: Up to Approximately Two Years

Secondary outcomes (8)

  1. Maximum Observed Serum Concentration (Cmax) of ABBV-101

    Maximum observed serum concentration of ABBV-101.

    Measured: Up to Approximately One Year

  2. Time to Cmax (Tmax) of ABBV-101

    Time to Cmax of ABBV-101.

    Measured: Up to Approximately One Year

  3. Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-101

    Area under the serum concentration versus time curve (AUC) of ABBV-101.

    Measured: Up to Approximately One Year

  4. Maximum Observed Serum Concentration (Cmax) of Venetoclax

    Maximum observed serum concentration of venetoclax.

    Measured: Up to Approximately One Year

  5. Time to Cmax (Tmax) of Venetoclax

    Time to Cmax of venetoclax.

    Measured: Up to Approximately One Year

  6. Area Under the Serum Concentration Versus Time Curve (AUC) of Venetoclax

    Area under the serum concentration versus time curve (AUC) of venetoclax.

    Measured: Up to Approximately One Year

  7. Number of Participants with Response of Partial Response (PR) or Better Response (Overall Response) per Disease-Specific Criteria

    Number of participants with response of PR or better response (overall response) per disease-specific criteria.

    Measured: Up to Approximately Two Years

  8. Duration of Response (DOR)

    DOR is defined for participants achieving PR or better as the time from the initial response per Investigator review to disease progression or death of any cause, whichever occurs earlier.

    Measured: Up to Approximately Two Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2023
  2. Study start9 Jun 2023
  3. Primary completionMar 2031 (estimated)
  4. Study completionMar 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05753501
Sponsor's protocol ID
M23-647
Other IDs
2023-503594-38-00, 2023
Status last verified
Aug 2026
First submitted
22 Feb 2023
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABBV-101 and Venetoclax in people with Hematologic Cancer, run by AbbVie at 51 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, France, Germany, Spain, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events (AE) (time frame: Up to Approximately 100 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05753501.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.

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