Odronextamab for Lymphoma
(ELM-1 Trial)

Recruiting in Palo Alto (17 mi)

+22 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Regeneron Pharmaceuticals

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This study has two parts with distinct study objectives and study design. In part A, odronextamab is studied as an intravenous (IV) administration with a dose escalation and a dose expansion phase for B-NHL and CLL. The dose escalation phase for B-NHL and the CLL study are closed at the time of protocol amendment 17. In part B, odronextamab is studied as a subcutaneous (SC) administration with a dose finding and a dose expansion phase for B-NHL.

Research Team

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Eligibility Criteria

This trial is for people with certain B-cell blood cancers (like lymphoma or leukemia) that haven't responded to previous treatments. Participants must have good bone marrow function, a specific performance status, and measurable cancer lesions. They can't join if they've had recent chemotherapy, CNS issues, HIV/HBV/HCV infections, or live vaccinations within the last month.

Inclusion Criteria

I have a tumor larger than 1.5 cm that can be measured by a scan.

I am willing to have a biopsy if my doctor thinks it's safe.

I have FL grade 1-3a or DLBCL and have had at least 2 treatments including an anti-CD20 antibody and an alkylating agent.

See 9 more

Exclusion Criteria

I haven't had chemotherapy or radiotherapy for lymphoma in the last 28 days.

I do not have HIV, HBV, HCV, or CMV infections.

I have hepatitis B but it's under control and I'm on antiviral therapy.

See 4 more

Treatment Details

Interventions

Odronextamab (Monoclonal Antibodies)

Trial OverviewThe study tests Odronextamab at various doses in two parts: Part A uses IV administration for dose escalation/expansion in B-NHL and CLL patients; Part B explores subcutaneous administration for dose finding/expansion specifically in B-NHL patients.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Part AExperimental Treatment1 Intervention

DLBCL post CAR-T

Group II: 2N Part BExperimental Treatment1 Intervention

DLBCL

Group III: 1N Part BExperimental Treatment1 Intervention

Odronextamab is already approved in European Union for the following indications:

🇪🇺 Approved in European Union as Ordspono for: