ABBV-101 for Blood Cancers

Recruiting at48 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: AbbVie

Must not be taking: BTK degraders

Disqualifiers: Active CNS disease, HIV, Hepatitis, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests ABBV-101, a new drug for treating certain blood cancers, in adults who haven't responded to other treatments. It aims to find the safest dose and check if the drug can reduce cancer activity.

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.

What data supports the effectiveness of the treatment ABBV-101 for blood cancers?

The research on autologous cell vaccines, which are similar to ABBV-101, shows they are generally safe and have a trend towards effectiveness in treating blood cancers, with a complete response rate of 21% and a 5-year overall survival rate of 64.9% in some studies. ^{1 2 3 4 5}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• ABBV-101 (Monoclonal Antibodies)

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.

Participant Groups

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

Findings from Research

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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of autologous whole cell vaccines in hematologic malignancies: A systematic review and meta-analysis. [2021]

2. United States 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. [2019]

3. United States 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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

WT1 and PRAME RNA-loaded dendritic cell vaccine as maintenance therapy in de novo AML after intensive induction chemotherapy. [2023]

5. China pubmed.ncbi.nlm.nih.gov

[Reduced intensity conditioning regimen for related and unrelated allogeneic peripheral blood hematopoietic stem cell transplantation in chronic myeloid leukemia.]. [2018]