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New treatment option for Non-Hodgkin's Lymphoma
Official title Study to Evaluate Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-291 Moves Through the Body in Adult Participants With Non-Hodgkin's Lymphoma
ClinicalTrials.gov ID: NCT06667687
What this study is testing
What is ABBV-291?
ABBV-291 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-hodgkin's lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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, tolerability, pharmacokinetics, and preliminary efficacy of ABBV-291 in adult participants in relapsed or refractory (R/R) NHL, including but not limited to diffuse large b-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), and follicular lymphoma (FL).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- For dose escalation (Part 1) only: Participants must have documented diagnosis of B-cell malignancies including (but not limited to) the following...
- Mantle cell lymphoma (MCL);
- Marginal zone lymphoma (MZL);
- Waldenstrom macroglobulinemia (WM);
- Diffuse large b-cell lymphoma (DLBCL) (including: germinal center B-cell type, activated B-cell type, primary cutaneous DLBCL [leg type]...
You likely can't join if
- History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or...
- Treatment with any of the following:
- Anticancer therapy including chemotherapy, radiotherapy, small molecule, investigational, and biologic agents within 14 days (or at least 5...
- CD79b-directed agents (e.g., CD79b monoclonal antibody therapy) within 4 weeks (or at least 5 half-lives, whichever is shorter) prior to the first...
- Prior treatment with an antibody drug conjugate that consists of a topoisomerase I inhibitor.
See the full eligibility criteria
- For dose escalation (Part 1) only: Participants must have documented diagnosis of B-cell malignancies including (but not limited to) the following, with histology based on criteria established by the World Health...
- Mantle cell lymphoma (MCL);
- Marginal zone lymphoma (MZL);
- Waldenstrom macroglobulinemia (WM);
- Diffuse large b-cell lymphoma (DLBCL) (including: germinal center B-cell type, activated B-cell type, primary cutaneous DLBCL [leg type], Epstein-Barr virus-positive (EBV+) DLBCL [not otherwise specified], DLBCL...
- FL Grades 1 to 3B;
- For dose expansion (Part 2) only: Participants must have documented diagnosis of one of the following B-cell malignancies, with histology based on criteria established by the WHO, and measurable disease requiring...
- Part 2a only: DLBCL (including: germinal center B-cell type, activated B-cell type, primary cutaneous DLBCL [leg type], EBV+ DLBCL [not otherwise specified], DLBCL associated with chronic inflammation, HHV8+ DLBCL [not...
- Part 2b only: FL Grades 1 to 3B;
- Part 2c only: Mantle cell lymphoma;
- For all participants (Parts 1 and 2):
- Must be considered relapsed or refractory to, or intolerant of, at least 2 or more prior lines of therapy known to provide a clinical benefit for their condition, and for whom there is no appropriate locally available...
- Indolent non-Hodkin's lymphoma (NHL) participants must meet relevant disease specific requirements for treatment (e.g., National Comprehensive Cancer Network [NCCN], Groupe d'Etude des Lymphomes Folliculaires [GELF]).
- History of allogeneic stem cell transplantation must be stable off of immunosuppression for at least 3 months.
- For participants enrolled in backfill cohorts or at dose levels previously cleared, people must provide consent to an on-treatment fresh tumor biopsy from the same tumor lesion as the baseline tumor tissue. This...
- Previously treated with a CD79b-targeting therapy (e.g., CD79b monoclonal antibody) a core or excision tumor biopsy subsequent to the most recent CD79b-targeting therapy must be collected. Tumor biopsy requirements may...
- CD79b expression status will be assessed in all participants.
- Have an eastern cooperative oncology group (ECOG) Performance Status of 0 or 1.
- Laboratory values meeting the criteria in the protocol within the screening period prior to the first dose of study drug (if multiple samples are drawn within the screening period, the sample/result immediately prior to...
- Availability of representative baseline tumor tissue (most recent archived tumor tissue or fresh biopsy collected during screening phase) suitable for immunohistochemistry (IHC) testing. This requirement may be waived...
- History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis.
- Treatment with any of the following:
- Anticancer therapy including chemotherapy, radiotherapy, small molecule, investigational, and biologic agents within 14 days (or at least 5 half-lives, whichever is shorter), prior to the first dose of the study...
- CD79b-directed agents (e.g., CD79b monoclonal antibody therapy) within 4 weeks (or at least 5 half-lives, whichever is shorter) prior to the first dose of study treatment.
- Prior treatment with an antibody drug conjugate that consists of a topoisomerase I inhibitor.
The study team makes the final eligibility decision.
Where it's taking place
- Huntersville, North Carolina, United States
- Eugene, Oregon, United States
- Austin, Texas, United States
- West Valley City, Utah, United States
- Fairfax, Virginia, United States
- Fitzroy Melbourne, Victoria, Australia
- Nedlands, Western Australia, Australia
- Jerusalem, Jerusalem, Israel
- Tel Aviv, Tel Aviv, Israel
- Nagoya, Aichi-ken, Japan
- Kashiwa-shi, Chiba, Japan
- Koto-ku, Tokyo, Japan
- Manchester, United Kingdom
- Plymouth, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Huntersville, North Carolina, United States; Eugene, Oregon, United States; Austin, Texas, United States; West Valley City, Utah, United States; Fairfax, Virginia, United States; Fitzroy Melbourne, Victoria, Australia and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.