← Back to Search

Monoclonal Antibodies

ABBV-291 for Non-Hodgkin's Lymphoma

Phase 1

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of allogeneic stem cell transplantation must be stable off of immunosuppression for at least 3 months

Have an eastern cooperative oncology group (ECOG) Performance Status of 0 or 1

Must not have

History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis

Prior treatment with an antibody drug conjugate that consists of a topoisomerase I inhibitor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 74 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to test the safety, effectiveness, and proper dosage of a new drug called ABBV-291 for treating Non-Hodgkin's lymphoma. The study will involve adult patients

Who is the study for?

Adults with relapsed or refractory Non-Hodgkin's Lymphoma, including types like DLBCL, MCL, and FL. Participants must be willing to undergo frequent medical assessments and blood tests at an approved institution.

What is being tested?

The trial is testing ABBV-291, a new drug for NHL. It includes two phases: first determining the maximum safe dose (MAD/MTD) through escalating doses; then assessing changes in disease activity at optimized doses over approximately 74 months.

What are the potential side effects?

Potential side effects of ABBV-291 are not specified but will be closely monitored throughout the study via regular medical assessments and blood tests to ensure participant safety.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I had a stem cell transplant and have not taken immunosuppressants for 3 months.

Select...

I am fully active or have some restrictions but can still carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had lung inflammation or disease that needed steroid treatment.

Select...

I have been treated with a specific drug that targets cancer cells.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 74 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 74 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 74 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR)

Percentage of Participants with Adverse Events (AE)s

Percentage of Participants with Clinically Significant Electrocardiogram (ECG) Findings

+3 more

Secondary study objectives

Area Under the Curve (AUC) of ABBV-291

Duration of Response (DOR) as Assessed by Investigator

Half-Life (t1/2) of ABBV-291

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Optimization: Mantle Cell Lymphoma (MCL) ABBV-291 Dose AExperimental Treatment1 Intervention

Participants with R/R MCL will receive the dose A of ABBV-291, as part of the 74 month study duration.

Group II: Optimization: MCL ABBV-291 Dose CExperimental Treatment1 Intervention

Participants with R/R MCL will receive the dose C of ABBV-291, as part of the 74 month study duration.

Group III: Optimization: MCL ABBV-291 Dose BExperimental Treatment1 Intervention

Participants with R/R MCL will receive the dose B of ABBV-291, as part of the 74 month study duration.

Group IV: Expansion: Follicular Lymphoma (FL) ABBV-291Experimental Treatment1 Intervention

Participants with R/R FL will receive the RP1ED of ABBV-291, as part of the 74 month study duration.

Group V: Expansion: Diffuse Large B-Cell Lymphoma (DLBCL) ABBV-291Experimental Treatment1 Intervention

Participants with R/R DLBCL will receive the recommended Phase 1 expansion dose (RP1ED) of ABBV-291, as part of the 74 month study duration.

Group VI: Escalation: Non-Hodgkin Lymphoma (NHL) ABBV-291Experimental Treatment1 Intervention

Participants with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (NHL), except chronic lymphocytic leukemia (CLL), will receive escalating doses of ABBV-291, as part of the 74 month study duration.

0 / 4Eligibility criteria met