Safety, Pharmacokinetics and Efficacy of ABBV-291
Research type
Research Study
Full title
A Phase 1 First-In-Human Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-291 in Non-Hodgkin's Lymphoma
IRAS ID
1010411
Contact name
Nina McGonnell
Contact email
Sponsor organisation
AbbVie Deutschland GmBH & Co. KG
Eudract number
2024-512586-13
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to assess the safety and tolerability of ABBV-291 in participants with B-cell Non-Hodgkin’s Lymphoma.
The study will enrol relapsed or refractory participants with B-cell malignancies (including but not limited to diffuse large B cell lymphoma (DLBCL), follicular lymphoma (FL) and mantle-cell lymphoma (MCL)).
The study is divided into two parts, dose escalation, and dose expansion/optimisation. The study doctor will let participants know which part they will be taking part in and discuss their treatment.
Part 1 (Dose Escalation): Approximately 45 participants with relapsed or refractory B-cell malignancies will receive gradually increasing doses of ABBV-291 until the highest safe dose of ABBV-291 is determined.
Part 2 (Dose Expansion/Optimisation): Once the highest safe dose of ABBV-291 is determined, approximately 120 participants with relapsed or refractory B-cell malignancies will be enrolled as follows:
• Part 2A, approximately 20 participants with relapsed or refractory DLBCL will be enrolled.
• Part 2B, approximately 20 participants with relapsed or refractory FL will be enrolled.
• Part 2C, participants with relapsed or refractory MCL will be randomly assigned to receive one of at least two dose levels of ABBV-291. Approximately 20 participants will be enrolled in each of the dose levels.
Total participation in this study is difficult to predict. Participants may receive treatment until their cancer worsens, until they have side effects that require stopping, or until they or their study doctor stops their participation in the study. As an estimate, participation may be expected to last approximately 3 years.
The total number of participants planned is approximately 165. Participants may undergo the following procedures: Physical examination, vital signs, electrocardiogram (to check the heart), blood and urine samples, tumour biopsy, imaging scans, bone marrow biopsy and subcutaneous injection (under the skin)REC name
West of Scotland REC 1
REC reference
24/WS/0167
Date of REC Opinion
14 Feb 2025
REC opinion
Further Information Favourable Opinion