Assessing the safety and effectiveness of ABBV-319 in treating certain types of B-cell lymphomas and leukemia
A First In Human Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-319 in B-cell Malignancies
This study is testing a new drug called ABBV-319 to see if it can safely help adults with certain types of B-cell lymphomas and leukemia that haven't responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 154 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 20 sites (Tucson, Arizona and 19 other locations) |
| Trial ID | NCT05512390 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety, tolerability, and pharmacokinetics of ABBV-319, an investigational drug, in adult participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), or chronic lymphocytic leukemia (CLL). The study consists of a dose escalation phase to determine appropriate dosing and a dose expansion phase to assess changes in disease activity. Approximately 154 adult participants will be enrolled to monitor adverse events and preliminary efficacy of the treatment.
Who should consider this trial
Good fit: Ideal candidates include adults with relapsed or refractory DLBCL, FL, or CLL who have measurable disease requiring treatment.
Not a fit: Patients who have not been diagnosed with B-cell malignancies or those with stable disease not requiring 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 for B-cell malignancies, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * For dose escalation (Part 1) only: Participants with documented diagnosis of B-cell malignancies including those with histology based on criteria established by the World Health Organization (WHO), and measurable disease requiring treatment, as per the protocol. * For the relapsed or refractory diffuse large b-cell lymphoma (DLBCL), follicular lymphoma (FL), and Chronic lymphocytic leukemia (CLL) dose expansion cohorts (Part 2) only: Participants with documented diagnosis of one of the B-cell malignancies noted in the protocol with histology based on criteria established by the WHO, and measurable disease requiring treatment, as per the protocol. * Laboratory values meeting the criteria noted in the protocol. * For participants previously treated with a CD19-targeting therapy (eg, CD19 monoclonal antibody) a core or excision tumor biopsy subsequent to the most recent CD19-targeting therapy must be collected. * Participant must have measurable disease, as defined by the 2014 Lugano Classification. Exclusion Criteria: * Known active central nervous system (CNS) disease, or primary CNS lymphoma. * Known active infection or clinically significant uncontrolled conditions as per the protocol. * Eastern Cooperative Oncology Group (ECOG) performance status \>= 2.
Where this trial is running
Tucson, Arizona and 19 other locations
- University of Arizona Cancer Center - Tucson /ID# 247752 — Tucson, Arizona, United States (Recruiting)
- Sylvester Comprehensive Cancer Center - University of Miami /ID# 247232 — Miami, Florida, United States (Completed)
- Allina Health System /ID# 251782 — Minneapolis, Minnesota, United States (Recruiting)
- University of Nebraska Medical Center /ID# 246715 — Omaha, Nebraska, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center-Koch Center /ID# 249246 — New York, New York, United States (Recruiting)
- Novant Health Presbyterian Medical Center /ID# 246719 — Charlotte, North Carolina, United States (Recruiting)
- Baylor Sammons Cancer Center /ID# 247715 — Dallas, Texas, United States (Recruiting)
- University of Texas Health San Antonio MD Anderson Cancer Center /ID# 256234 — San Antonio, Texas, United States (Recruiting)
- Concord Repatriation General Hospital /ID# 249240 — Concord, New South Wales, Australia (Recruiting)
- St Vincent's Hospital Melbourne /ID# 247624 — Fitzroy Melbourne, Victoria, Australia (Recruiting)
- One Clinical Research Pty Ltd /ID# 248392 — Nedlands, Western Australia, Australia (Recruiting)
- Cross Cancer Institute /ID# 246717 — Edmonton, Alberta, Canada (Completed)
- University Health Network_Princess Margaret Cancer Centre /ID# 243936 — Toronto, Ontario, Canada (Recruiting)
- The Chaim Sheba Medical Center /ID# 254884 — Ramat Gan, Tel Aviv, Israel (Completed)
- Hadassah Medical Center-Hebrew University /ID# 254885 — Jerusalem, Israel (Recruiting)
- Seoul National University Hospital /ID# 263945 — Seoul, Seoul Teugbyeolsi, South Korea (Recruiting)
- Asan Medical Center /ID# 263220 — Seoul, Seoul Teugbyeolsi, South Korea (Recruiting)
- Samsung Medical Center /ID# 263294 — Seoul, Seoul Teugbyeolsi, South Korea (Recruiting)
- Hospital Universitario Marques de Valdecilla /ID# 262826 — Santander, Cantabria, Spain (Recruiting)
- Hospital Universitario Fundacion Jimenez Diaz /ID# 265198 — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.