🏛️ Verified NIH Record • Updated 2026-08-13

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 (NCT06667687)

A Phase 1 First-In-Human Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV 291 in Non-Hodgkin's Lymphoma

🔵 Active, Not Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: AbbVie

🩺 Plain-English Summary (8th-Grade Level)

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). Adverse events will be assessed. ABBV-291 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-291 and a dose expansion/optimization phase to determine the change in disease activity in participants with R/R NHL. Approximately 165 adult participants with multiple NHL subtypes will be enrolled in the study in sites world wide In the dose escalation phase of the study participants will receive escalating Intravenously (IV) infused doses of ABBV-291, until the MAD/MTD is determined. In the dose expansion/optimization phase of the study participants receive IV infused ABBV-291, as part of the approximately 74 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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (20 items) and avoid the listed exclusions (6 items).

Location: Carolina BioOncology Institute /ID# 265259 — Huntersville, North Carolina

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • 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 treatment;
  • 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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (14 Sites)

  • Carolina BioOncology Institute /ID# 265259 — Huntersville, North Carolina
  • Willamette Valley Cancer Institute and Research Center /ID# 270945 — Eugene, Oregon
  • Texas Oncology - Central/South Texas /ID# 270946 — Austin, Texas
  • START Mountain Region /ID# 267592 — West Valley City, Utah
  • Virginia Cancer Specialists - Fairfax /ID# 265082 — Fairfax, Virginia
  • St Vincent's Hospital Melbourne /ID# 261664 — Fitzroy Melbourne, Victoria
  • Sir Charles Gairdner Hospital /ID# 268579 — Nedlands, Western Australia
  • Hadassah Medical Center-Hebrew University /ID# 261658 — Jerusalem, Jerusalem
  • Tel Aviv Sourasky Medical Center /ID# 261659 — Tel Aviv, Tel Aviv
  • Aichi Cancer Center /ID# 267471 — Nagoya, Aichi-ken
  • National Cancer Center Hospital East /ID# 261775 — Kashiwa-shi, Chiba
  • The Cancer Institute Hospital Of JFCR /ID# 267470 — Koto-ku, Tokyo
  • The Christie /ID# 267177 — Manchester,
  • University Hospitals Plymouth NHS Trust /ID# 267174 — Plymouth,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
  • 💵 Compensation indicated: Approximately 165 adult participants with multiple NHL subtypes will be enrolled in the study in sites world wide In the dose escalation phase of the study participants will receive escalating Int...

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗