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Monoclonal Antibodies

Imvotamab for Non-Hodgkin's Lymphoma

Phase 1 & 2

Waitlist Available

Research Sponsored by IGM Biosciences, Inc.

Eligibility Criteria Checklist

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

Must have

At least one bi-dimensionally measurable lesion (>1.5cm in it's longest dimension by computerized tomography (CT scan))

> 18 years of age: ECOG PS 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 5 years

Awards & highlights

Study Summary

This trial is testing a new drug, IGM-2323, for people with a certain type of cancer that has come back or is not responding to treatment. The trial will have two parts, first testing different doses of the drug to see what is safe, then expanding to a larger group of people to see if the drug is effective. The drug will be given intravenously.

Who is the study for?

Adults over 18 with certain types of Non-Hodgkin Lymphoma (NHL) who have tried at least two treatments, including anti-CD20 chemo-immunotherapy, and are not candidates for stem cell transplant. They must have a measurable lesion on a CT scan and be in good health otherwise.Check my eligibility

What is being tested?

The trial is testing imvotamab alone or combined with other therapies in patients with relapsed/refractory B-cell NHL. It includes dose-escalation to find safe amounts, combination therapy stages, and expansion cohorts specific to the type of lymphoma.See study design

What are the potential side effects?

Potential side effects of imvotamab may include reactions related to infusion such as fever or chills, organ inflammation, fatigue, blood disorders that can affect immune response and increase infection risk.

Eligibility Criteria

Inclusion Criteria

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

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I have a tumor larger than 1.5cm detectable by CT scan.

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I am over 18 and can care for myself with minimal assistance.

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My lymphoma has returned or didn't respond to treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Overall Frequency of Adverse Events

Overall Response Rate (ORR)

Secondary outcome measures

Duration of Response (DOR)

Objective Response Rate (ORR)

Trial Design

6Treatment groups

Experimental Treatment

Group I: Phase 2 (FL)Experimental Treatment1 Intervention

FL subjects will receive imvotamab via IV infusion at a dose and schedule to be determined after reviewing all available response and safety data. No longer enrolling.

Group II: Phase 2 (DLBCL)Experimental Treatment1 Intervention

DLBCL subjects will receive imvotamab via IV infusion at a dose and schedule to be determined after reviewing all available response and safety data. No longer enrolling.

Group III: Phase 1b (Combination)Experimental Treatment1 Intervention

Subjects will receive imvotamab via IV infusion weekly and loncastuximab tesirine via IV infusion every 3 weeks.

Group IV: Phase 1a (Q3W)Experimental Treatment1 Intervention

Subjects will receive imvotamab via intravenous (IV) infusion every 3 weeks. No longer enrolling.

Group V: Phase 1a (Prior bi-specific)Experimental Treatment1 Intervention

Subjects treated with prior bi-specifics will receive imvotamab via IV infusion weekly. No longer enrolling.

Group VI: Phase 1a (Dose Escalation)Experimental Treatment1 Intervention

Subjects will receive imvotamab via intravenous (IV) infusion weekly. No longer enrolling.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

ADC Therapeutics S.A.Industry Sponsor

28 Previous Clinical Trials

2,136 Total Patients Enrolled

IGM Biosciences, Inc.Lead Sponsor

7 Previous Clinical Trials

272 Total Patients Enrolled

Wayne Godfrey, M.D.Study DirectorIGM Biosciences, Inc.

Media Library

IGM-2323 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04082936 — Phase 1 & 2

Non-Hodgkin's Lymphoma Research Study Groups: Phase 1a (Prior bi-specific), Phase 1a (Dose Escalation), Phase 1a (Q3W), Phase 2 (DLBCL), Phase 2 (FL), Phase 1b (Combination)

Non-Hodgkin's Lymphoma Clinical Trial 2023: IGM-2323 Highlights & Side Effects. Trial Name: NCT04082936 — Phase 1 & 2

IGM-2323 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04082936 — Phase 1 & 2

Frequently Asked Questions

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

Are there any vacancies for participants in this experiment?

"Indeed, the information on clinicaltrials.gov shows that this trial has been recruiting patients since its inception in September 2019 and is still doing so as of 29th September 2022. There are 9 different medical sites participating in the study and 260 hopeful participants to be enrolled overall."

Answered by AI

How many places are overseeing the implementation of this trial?

"At the moment, this clinical trial is enrolling patients from 9 sites. These locations span Seattle, Nashville and Boston among other cities. To reduce travel requirements if you choose to join, we recommend selecting the site closest to your home location."

Answered by AI

What is the current capacity for participants in this research project?

"To fully recruit for this medical trial, 260 suitable patients need to be enrolled. These individuals can join the study from either Fred Hutch in Seattle or Tennessee Oncology in Nashville."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Imvotamab Monotherapy and in Combination in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma

2019. "A Study of Imvotamab Monotherapy and in Combination in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04082936.

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