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Checkpoint Inhibitor

Dose Level Assignments for B-Cell Lymphoma

Phase 1

Waitlist Available

Led By Mayur Narkhede

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 and 24 months

Awards & highlights

Study Summary

"This trial is looking at the best dose and benefits of combining three experimental immunotherapy drugs, Retifanlimab, INCAGN02385, and INCAGN02390, to enhance the

Who is the study for?

This trial is for individuals with certain types of blood cancer, including Diffuse Large B-Cell Lymphoma and other related lymphomas. Participants should have had a suboptimal response to CAR T-cell therapy and meet specific health criteria not detailed here.Check my eligibility

What is being tested?

The study tests combining three investigational drugs: Retifanlimab, INCAGN02385, and INCAGN02390. It aims to find the best dose and see if this triple drug combo can make CAR T-cell therapy work better for those who didn't respond well initially.See study design

What are the potential side effects?

Potential side effects may include immune system reactions, fatigue, infusion-related symptoms, possible organ inflammation due to checkpoint blockade (PD-1, TIM-3 & LAG-3), but exact side effects are not specified.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Identify the optimal biological dose (OBD) for Retifanlimab in combination with INCAGN02385 and INCAGN02390 in relapsed/refractory DLBCL.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose Level AssignmentsExperimental Treatment1 Intervention

Dose Level 1 Retifanlimab 375mg INCAGN02385 250mg INCAGN02390 200mg Dose Level 2 Retifanlimab 500mg INCAGN02385 250mg INCAGN02390 200mg Dose Level 3 Retifanlimab 750mg INCAGN02385 250mg INCAGN02390 200mg

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,591 Previous Clinical Trials

2,281,647 Total Patients Enrolled

Mayur NarkhedePrincipal InvestigatorUniversity of Alabama at Birmingham

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants currently being accepted for enrollment in this ongoing medical study?

"As per information available on clinicaltrials.gov, the current status of this medical investigation does not involve participant recruitment. This particular trial was initially shared on April 30th, 2024, with the most recent update occurring on February 26th, 2024. Despite its inactive recruitment phase, it is noteworthy that there are currently 1754 ongoing studies actively seeking candidates for enrollment."

Answered by AI

Has the third dosage level of this medication been granted approval by the Food and Drug Administration?

"As per the evaluation by our team at Power, Dose level 3 is rated as a safety level of 1 on the scale from 1 to 3. This assessment aligns with Phase 1 trial parameters indicating scarce evidence supporting both safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PD-1, LAG-3 and TIM-3 Checkpoint Blockade in DLBCL

Mayur Narkhede 2024. "PD-1, LAG-3 and TIM-3 Checkpoint Blockade in DLBCL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06290622.

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