Non Hodgkin Lymphoma Clinical Trial

Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies

Summary

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.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Have documented CD20+ B-cell malignancy, with active disease not responsive to prior therapy, for whom no standard of care options exists, and for whom treatment with an anti-CD20 antibody may be appropriate:

Part A (IV administration) B-NHL confirmed by National Cancer Institute (NCI) working group criteria
Part B (SC administration): Confirmed diagnosis of B-NHL requiring therapy as defined by WHO classification 2017

Patients with B-NHL must have had prior treatment with an anti-CD20 antibody therapy. Patients with CLL (Part A only) are not required to have received prior treatment with an anti-CD20 antibody therapy as defined in the protocol.

For the inclusion in the disease-specific expansion cohort enrolling DLBCL patients after failure of CAR-T therapy, the patient must have recovered from the toxicities of the lymphodepletion therapy and CAR-T infusion.
For inclusion in Part B, patients must have FL grade 1-3a or DLBCL (with or without prior CAR-T) per the criteria above, and:
Patients with FL grade 1-3a and DLBCL must have received at least 2 prior lines of systemic therapy, including an anti-CD20 antibody and an alkylating agent
All patients must have at least one bi-dimensionally measurable lesion ≥1.5 cm) documented by CT or MRI scan, if CT scan is not feasible.
Eastern Cooperative Oncology Group (ECOG) performance status ≤1
Life expectancy of at least 6 months
Adequate bone marrow function as described in the protocol
Adequate organ function as described in the protocol
Willingness to undergo mandatory tumor biopsy pretreatment, if in the opinion of the investigator, the patient has an accessible lesion that can be biopsied without significant risk to the patient.
Willing and able to comply with clinic visits and study-related procedures
Provide signed informed consent or legally acceptable representative

Key Exclusion Criteria:

Primary central nervous system (CNS) lymphoma or known or suspected CNS involvement by non-primary CNS NHL

History of or current relevant CNS pathology such as

Epilepsy, seizure, paresis, aphasia, apoplexia, severe brain injuries, cerebellar disease, organic brain syndrome, psychosis, or
Evidence for presence of inflammatory lesions and/or vasculitis on cerebral MRI
Standard anti-lymphoma chemotherapy (non-biologic) or radiotherapy within 28 days prior to first administration of study drug

Infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or cytomegalovirus (CMV) infection [(as noted by detectable levels on a blood polymerase chain reaction (PCR) assay)].

Patients with hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus deoxyribonucleic acid (DNA) that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted upon consultation with the physician managing the infection.
Patients who show detectable levels of CMV at screening will need to be treated with appropriate antiviral therapy and demonstrate at least 2 undetectable levels of CMV by PCR assay (at least 7 days apart) before being re-considered for eligibility.
Patients who have received a live vaccination within 28 days of first dose of study treatment

Note: Other protocol Inclusion/Exclusion criteria apply

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

298

Study ID:

NCT02290951

Recruitment Status:

Recruiting

Sponsor:

Regeneron Pharmaceuticals

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There are 14 Locations for this study

See Locations Near You

University of California, Irvine
Orange California, 92868, United States
Stanford University
Stanford California, 94305, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Dana Farber Cancer Institute (Massachusetts General Hospital and Beth Israel)
Boston Massachusetts, 02215, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Weill Cornell Medical College
New York New York, 10065, United States
Centre Henri Becquerel
Rouen Haute-Normandie, 76038, France More Info
Emmanuel Bachy
Principal Investigator
CHU Hôpital Lyon Sud
Lyon , 69495, France
Institut Gustave Roussy
Villejuif Île-de-France, 94800, France
Universitatsklinikum Wurzburg
Wurzburg Bayern, 97080, Germany
Meir Medical Center
Kfar Saba HaMerkaz, 44281, Israel
The Christie NHS Foundation Trust
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

298

Study ID:

NCT02290951

Recruitment Status:

Recruiting

Sponsor:


Regeneron Pharmaceuticals

How clear is this clinincal trial information?

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