A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Participants With Aggressive B-cell Non-Hodgkin Lymphomas - Clinical Trial for B-cell Non-Hodgkins Lymphoma (B-NHL) | NCT05685173

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Primary Purpose

Status

Recruiting

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Odronextamab

REGN5837

About this trial

This is an interventional treatment trial for B-cell Non-Hodgkins Lymphoma (B-NHL) focused on measuring Aggressive B-Cell Non-Hodgkin Lymphomas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria: Have documented CD20+ aggressive B-NHL, with disease that has progressed after at least 2 lines of systemic therapy containing an anti-CD20 antibody and an alkylating agent. Measurable disease on cross sectional imaging as defined in the protocol Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Adequate bone marrow, renal and hepatic function as defined in the protocol During dose expansion phase of the study, participant should be willing to undergo mandatory tumor biopsies, if in the opinion of the investigator, the participant has an accessible lesion that can be biopsied without significant risk to the participant. Key Exclusion Criteria: Prior treatments with allogeneic stem cell transplantation or solid organ transplantation, treatment with anti-CD20 x anti- CD3 bispecific antibody, such as odronextamab Diagnosis of mantle cell lymphoma (MCL) Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS lymphoma Treatment with any systemic anti-lymphoma therapy within 5 half-lives or within 14 days prior to first administration of study drug, whichever is shorter Standard radiotherapy within 14 days of first administration of study drug. Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or corticosteroid equivalent within 72 hours of start of odronextamab Co-morbid conditions, as described in the protocol Infections, as described in the protocol Allergy/hypersensitivity: Known hypersensitivity to both allopurinol and rasburicase NOTE: Other protocol defined inclusion / exclusion criteria apply

Sites / Locations

City of HopeRecruiting
Norton Cancer InstituteRecruiting
Laura and Isaac Perlmutter Cancer Center (NYU Cancer Institute (NYUCI)Recruiting
Royal Cornwall Hospitals NHS TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Odronextamab and REGN5837

Arm Description

Odronextamab and REGN5837 will be administered by IV infusion using a step-up dosing schedule.

Outcomes

Primary Outcome Measures

Incidence of Dose Limiting Toxicities (DLTs) of REGN5837 in combination with odronextamab

A DLT is defined as any non-haematologic and haematologic toxicity, as defined in the protocol, unless the event is clearly attributable to the underlying disease or to an extraneous cause (including concomitant medications).

Incidence of treatment-emergent adverse events (TEAEs) of REGN5837 in combination with odronextamab

Treatment-emergent adverse events (TEAEs) are defined as those AEs that newly occurred or worsened during the on-treatment period and any treatment-related serious adverse events (SAEs) that occurred during the post-treatment period.

Severity of TEAEs of REGN5837 in combination with odronextamab

Treatment-emergent adverse events (TEAEs) are defined as those AEs that newly occurred or worsened during the on-treatment period and any treatment-related serious adverse events (SAEs) that occurred during the post-treatment period.

Incidence of adverse events of special interest (AESIs) of REGN5837 in combination with odronextamab

An AESI (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate.

Severity of AESIs of REGN5837 in combination with odronextamab

An AESI (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate.

Secondary Outcome Measures

Concentrations of REGN5837 in the serum

Concentrations of odronextamab in the serum

Incidence of anti-drug antibodies (ADAs) to REGN5837

Incidence of ADAs to odronextamab

Titer of ADAs to REGN5837

Titer of ADAs to odronextamab

Overall response rate (ORR) according to the Lugano Classification of response

The ORR is defined as the proportion of patients who achieve a best overall response CR or PR during or following study treatment according to the Lugano Classification based on local investigator review.

Complete response (CR) rate according to the Lugano Classification of response

The CR rate is defined as the proportion of patients who achieve a best overall response CR during or following study treatment according to the Lugano Classification based on local investigator review.

Progression free survival (PFS) according to the Lugano Classification of response

PFS is defined as the time from the start of study treatment until the first date of progressive disease, or death due to any cause, whichever occurs first, based on local investigator review.

Overall survival (OS)

OS is measured from the start of study treatment until death due to any cause.

Duration of Response (DoR) according to the Lugano Classification of response

DOR is defined for responders (patients with a best overall response of CR or PR). It is the time from the date of the first documented CR or PR until the date of the first date of progressive disease, or death due to any cause, whichever occurs first, based on local investigator review.

Full Information

NCT ID

NCT05685173

First Posted

December 14, 2022

Last Updated

September 29, 2023

Sponsor

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT05685173

Brief Title

A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Participants With Aggressive B-cell Non-Hodgkin Lymphomas

Acronym

ATHENA-1

Official Title

A Phase 1 Study to Assess Safety and Tolerability of REGN5837, an Anti-CD22 x Anti-CD28 Costimulatory Bispecific Monoclonal Antibody, in Combination With Odronextamab, an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, in Patients With Aggressive B-Cell Non-Hodgkin Lymphomas (ATHENA-1)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 12, 2023 (Actual)

Primary Completion Date

June 2, 2027 (Anticipated)

Study Completion Date

May 16, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

The study is researching an experimental drug called REGN5837 in combination with another experimental drug, odronextamab. The aim of the study is to see how safe and tolerable the study drugs are, and to define the recommended dose for phase 2 for the combination. The study is focused on patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphomas (B-NHLs). The study is looking at several other research questions, including: What side effects may happen from taking the study drugs How much study drug is in your blood at different times Whether the body makes antibodies against the study drugs (that could make the drugs less effective or could lead to side effects) To find out how well the study drugs work against relapsed or refractory aggressive B-cell non-Hodgkin lymphomas (B-NHLs)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

B-cell Non-Hodgkins Lymphoma (B-NHL)

Keywords

Aggressive B-Cell Non-Hodgkin Lymphomas

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

91 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Odronextamab and REGN5837

Arm Type

Experimental

Arm Description

Odronextamab and REGN5837 will be administered by IV infusion using a step-up dosing schedule.

Intervention Type

Drug

Intervention Name(s)

Odronextamab

Other Intervention Name(s)

REGN1979

Intervention Description

Odronextamab will be administered by IV infusion

Intervention Type

Drug

Intervention Name(s)

REGN5837

Intervention Description

REGN5837 will be administered by IV infusion

Primary Outcome Measure Information:

Title

Incidence of Dose Limiting Toxicities (DLTs) of REGN5837 in combination with odronextamab

Description

A DLT is defined as any non-haematologic and haematologic toxicity, as defined in the protocol, unless the event is clearly attributable to the underlying disease or to an extraneous cause (including concomitant medications).

Time Frame

From Cycle 2, Day 15 to Cycle 4, Day 7 (each induction cycle is 21 days)

Title

Incidence of treatment-emergent adverse events (TEAEs) of REGN5837 in combination with odronextamab

Description

Treatment-emergent adverse events (TEAEs) are defined as those AEs that newly occurred or worsened during the on-treatment period and any treatment-related serious adverse events (SAEs) that occurred during the post-treatment period.

Time Frame

From dose 1 of study treatment, until the date of progression, assessed up to study completion, approximatively 5 years

Title

Severity of TEAEs of REGN5837 in combination with odronextamab

Description

Treatment-emergent adverse events (TEAEs) are defined as those AEs that newly occurred or worsened during the on-treatment period and any treatment-related serious adverse events (SAEs) that occurred during the post-treatment period.

Time Frame

From dose 1 of study treatment, until the date of progression, assessed up to study completion, approximatively 5 years

Title

Incidence of adverse events of special interest (AESIs) of REGN5837 in combination with odronextamab

Description

An AESI (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate.

Time Frame

From dose 1 of study treatment, until the date of progression, assessed up to study completion, approximatively 5 years

Title

Severity of AESIs of REGN5837 in combination with odronextamab

Description

An AESI (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate.

Time Frame

From dose 1 of study treatment, until the date of progression, assessed up to study completion, approximatively 5 years

Secondary Outcome Measure Information:

Title

Concentrations of REGN5837 in the serum

Time Frame