ABBV-101 for Blood Cancers

Recruiting at 69 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Must not be taking: BTK degraders

Disqualifiers: Active CNS disease, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

244 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests ABBV-101, a new drug for certain types of blood cancer, including non-Hodgkin's lymphoma. Researchers aim to determine if ABBV-101 is safe and effective for treating cancers like chronic lymphocytic leukemia and diffuse large B-cell lymphoma when other treatments have failed. The trial consists of two parts: one to determine the correct dose and another to assess the drug's effectiveness. Individuals with blood cancers that have returned or not responded to at least two treatments may qualify. Participants will need to visit a hospital or clinic regularly for check-ups and tests during the trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that prior use of a Bruton's tyrosine kinase inhibitor (BTKi) is allowed, which might suggest some medications can be continued. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that ABBV-101 is likely to be safe for humans?

Research shows that ABBV-101 remains in the early stages of testing for safety in individuals with blood cancers like non-Hodgkin's lymphoma. As a Phase 1 trial, the primary goal is to assess its safety and tolerability. Solid data is limited because this often marks the first human testing of the drug. Phase 1 trials typically involve small groups, with participants closely monitored for side effects.

ABBV-101 is designed to break down specific proteins that promote cancer cell growth. In similar studies, drugs with comparable mechanisms have shown promise in being safe and well-tolerated. However, ABBV-101 is unique, and results may vary.

Participants in this trial will be closely monitored for side effects, with doses adjusted as necessary. The aim is to find the right balance between the dose and any side effects experienced. Safety information is still being collected, so participation helps researchers learn more about ABBV-101's safety profile. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for non-Hodgkin's lymphoma?

Researchers are excited about ABBV-101 because it offers a novel approach for treating certain blood cancers. While most treatments for conditions like Non-Hodgkin's lymphoma, chronic lymphocytic leukemia, and diffuse large B-cell lymphoma often involve chemotherapy or targeted therapy, ABBV-101 works differently. This treatment is designed to fine-tune the immune system's response specifically against cancer cells, potentially leading to a more precise attack with fewer side effects. Its unique mechanism aims to control the disease more effectively, especially in cases where the cancer has returned or resisted previous treatments. This innovative approach holds promise for improving outcomes in patients who have limited options.

What evidence suggests that ABBV-101 might be an effective treatment for non-Hodgkin's lymphoma?

Research has shown that ABBV-101 could be a promising treatment for certain types of non-Hodgkin's lymphoma (NHL) that have returned or are difficult to treat, including chronic lymphocytic leukemia (CLL) and a type of diffuse large B-cell lymphoma (DLBCL). In this trial, participants with relapsed or refractory (R/R) NHL will receive escalating doses of ABBV-101 to determine the maximum tolerated dose. Once identified, this dose will be used in separate arms for participants with R/R CLL and R/R non-germinal center B cell (GCB) DLBCL. ABBV-101 works by breaking down a protein that aids cancer cell growth. Early lab studies showed it was very selective, suggesting it might cause fewer side effects while remaining effective. Although human studies provide limited information, early results suggest it could benefit patients who have already tried many treatments. Overall, ABBV-101 is under careful study for its potential to combat these challenging blood cancers. ^{1 2 4 6 7}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

Adults with certain types of blood cancers, including various forms of non-Hodgkin's lymphoma and chronic lymphocytic leukemia that have not responded to previous treatments. Participants should be in a stable health condition with an expected lifespan of at least 12 weeks and must not have active central nervous system disease or uncontrolled infections.

Inclusion Criteria

I have CLL or non-GCB DLBCL and need third-line treatment or beyond, including if I have BTK mutations or am CAR-T/HCT R/R.

I have been diagnosed with follicular lymphoma.

I am able to get out of my bed or chair and move around.

Exclusion Criteria

I have been treated with a BTK degrader before.

I do not have active brain disease or primary brain lymphoma.

I do not have an uncontrolled infection or active hepatitis B/C, HIV, or cytomegalovirus.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating oral doses of ABBV-101 until the maximum administered dose (MAD)/Maximum tolerated dose (MTD) is determined

Approximately 88 months

Regular visits at an approved institution

Dose Expansion

Participants receive oral ABBV-101 at the dose determined in the dose escalation phase

Approximately 88 months

Regular visits at an approved institution

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 2 years

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-101

Trial Overview The trial is testing ABBV-101, an oral medication for B-cell malignancies. It includes two phases: dose escalation to find the maximum tolerated dose and dose expansion to assess changes in disease activity. The study will last about 60 months and involves regular medical assessments.

How Is the Trial Designed?

Group I: Dose Expansion ABBV-101 R/R non-GCB DLBCL Experimental Treatment 1 Intervention

Participants 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 88 month study duration.

Group II: Dose Expansion ABBV-101 R/R Chronic Lymphocytic Lymphoma (CLL) Experimental Treatment 1 Intervention

Participants with R/R CLL will receive ABBV-101 at the dose determined in the dose escalation arm, as part of the approximately 88 month study duration.

Group III: Dose Escalation ABBV-101 Experimental Treatment 1 Intervention

Participants 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 88 month study duration.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Published Research Related to This Trial

Autologous cell vaccines, which use a patient's own tumor cells, show a promising safety profile with few high-grade adverse events reported, although challenges in manufacturing and patient eligibility limited the number of vaccinations administered (only 341 out of 592 enrolled participants received the vaccine).

In terms of efficacy, the complete response rate was 21% and the overall response rate was 35.8%, with a 5-year overall survival rate of 64.9% and disease-free survival rate of 59.7% among evaluable patients, indicating potential benefits in treating hematologic cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of autologous whole cell vaccines in hematologic malignancies: A systematic review and meta-analysis. Bastin, DJ., Khan, ST., Montroy, J., et al.[2021]

A recombinant adeno-associated virus vector encoding the BCR-ABL fusion region effectively primed human dendritic cells to stimulate specific T cell responses against chronic myelogenous leukemia (CML), demonstrating its potential as an immunotherapy.

The study identified HLA-DRB5(*)0101+DRA as a new restriction element for presenting the BCR-ABL fusion epitope, suggesting that this approach could enhance the development of targeted vaccines for CML.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity of a p210(BCR-ABL) fusion domain candidate DNA vaccine targeted to dendritic cells by a recombinant adeno-associated virus vector in vitro. Sun, JY., Krouse, RS., Forman, SJ., et al.[2022]

In a study of 44 chronic myeloid leukemia patients undergoing allogeneic peripheral blood stem cell transplantation (allo-PBSCT) with fludarabine-busulfan conditioning, the 5-year overall survival rate was 77.0%, indicating a promising long-term efficacy of this treatment.

The study found that this conditioning regimen is safe and less toxic, with a low incidence of acute and chronic graft-versus-host disease (GVHD), making it a viable curative option for patients with CML, regardless of whether the donor is related or unrelated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Reduced intensity conditioning regimen for related and unrelated allogeneic peripheral blood hematopoietic stem cell transplantation in chronic myeloid leukemia.]. Wang, JM., Zhang, WP., Song, XM., et al.[2018]

In a pilot study involving five patients with acute leukemia, two patients with acute lymphoblastic leukemia achieved complete remission after receiving donor PBBC cell transfusions following chemotherapy, indicating a potential effective treatment strategy.

The other three patients who did not receive chemotherapy before PBBC transfusions did not achieve remission and died shortly after, suggesting that prior chemotherapy may be crucial for the success of this immunotherapy approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transfusion of donor peripheral blood buffy coat cells as effective treatment for relapsed acute leukemia after transplantation of allogeneic bone marrow or peripheral blood stem cells from the same donor. Tzeng, CH., Lin, JS., Lee, JC., et al.[2019]

In a study involving 20 patients with acute myeloid leukemia (AML) in first complete remission, the autologous dendritic cell vaccine FDC101 was well tolerated, with only mild side effects, and resulted in 55% of patients remaining in remission over a 2-year period.

The five-year overall survival rate was 75%, indicating that this vaccine therapy could be a promising maintenance treatment for AML patients not eligible for stem cell transplantation, especially for older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

WT1 and PRAME RNA-loaded dendritic cell vaccine as maintenance therapy in de novo AML after intensive induction chemotherapy. Fløisand, Y., Remberger, M., Bigalke, I., et al.[2023]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.TPS7091

A first-in-human study of the potent and highly selective ... ABBV-101 is a reversible BTK degrader. By preclinical kinome profiling, ABBV-101 has demonstrated high selectivity with the potential for best-in-class AE ...

2. hematologyandoncology.net hematologyandoncology.net/archives/june-2025/the-development-of-btk-degraders-for-patients-with-relapsed-cll/

The Development of BTK Degraders for Patients With ... Now we have phase 1 clinical trial results with several of these BTK degrader molecules, and they do show very impressive efficacy in heavily pretreated ...

3. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/885/530857/Preliminary-Efficacy-and-Safety-of-the-Bruton

Preliminary Efficacy and Safety of the Bruton Tyrosine Kinase ... Preliminary efficacy and safety of the Bruton Tyrosine kinase degrader BGB-16673 in patients with relapsed or refractory chronic lymphocytic leukemia/small ...

4. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/abbv-101-abbvie-relapsed-chronic-lymphocytic-leukemia-cll-likelihood-of-approval/

ABBV-101 by AbbVie for Relapsed Chronic Lymphocytic ... According to GlobalData, Phase I drugs for Relapsed Chronic Lymphocytic Leukemia (CLL) have a 73% phase transition success rate (PTSR) ...

5. mdanderson.org mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2023-0106.html

First-in-human study to evaluate the safety, ... 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) ...

6. clinicalresearch.com clinicalresearch.com/en/find-trials/Study/NCT05753501

NCT05753501 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) ...

7. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M23-647

Study to Evaluate Adverse Events, Change in Disease ... 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.