A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Adult Participants With Aggressive B-cell Non-Hodgkin Lymphomas
NCT05685173 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 107
Last updated 2026-05-19
Summary
This study is researching an experimental drug called REGN5837 in combination with another drug, odronextamab (called "study drug\[s\]"), in patients with relapsed or refractory aggressive B-cell Non-Hodgkin Lymphomas (B-NHLs).
The study has 2 parts. The aim of the first part (dose escalation) is to find a safe dose of REGN5837 when given in combination with odronextamab.
The goal of the second part (dose expansion) is to use the REGN5837 drug dose found in the first part to see how well REGN5837 in combination with odronextamab works.
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 the 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)
Conditions
- B-cell Non-Hodgkins Lymphoma (B-NHL)
Interventions
- DRUG
-
Odronextamab
Administered per the protocol
- DRUG
-
REGN5837
Administered per the protocol
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trial Management · Regeneron Pharmaceuticals
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-04-20
- Primary Completion
- 2029-02-16
- Completion
- 2030-01-13
- FDA Drug
- Yes
Countries
- United States
- France
- Netherlands
- Spain
- United Kingdom
Study Locations
More Related Trials
-
A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies
NCT06634589 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Study to Learn How Safe and Tolerable Odronextamab and Cemiplimab Are in Adult Patients With B-cell Malignancies
NCT02651662 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Adult Participants With Previously Untreated Follicular Lymphoma
NCT06091254 ·Status: RECRUITING ·Phase: PHASE3
-
A Trial to Find Out if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Adult Participants With Follicular Lymphoma and Marginal Zone Lymphoma
NCT06149286 ·Status: RECRUITING ·Phase: PHASE3
-
A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Adult Patients With Previously Untreated Diffuse Large B-cell Lymphoma
NCT06091865 ·Status: RECRUITING ·Phase: PHASE3
-
Oblimersen, Rituximab and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
NCT00086944 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)
NCT04663347 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Fenretinide and Rituximab in Treating Patients With B-Cell Non-Hodgkin Lymphoma
NCT00288067 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Combination Chemotherapy and Rituximab With Pegfilgrastim Followed by Rituximab, in Large B-Cell Non-Hodgkin's Lymphoma
NCT00193479 ·Status: COMPLETED ·Phase: PHASE2
-
Trial to Define the Safety and Tolerability of SGN-40, Rituximab, and Gemcitabine in Patients With DLBCL
NCT00655837 ·Status: COMPLETED ·Phase: PHASE1
-
GZL Sequential CD19/CD22 CAR-T in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
NCT05797948 ·Status: UNKNOWN ·Phase: NA
-
A Trial to Learn if Odronextamab Combined With Chemotherapy is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Chemotherapy for Adult Participants With Follicular Lymphoma
NCT06097364 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Trial of Bendamustine, Bortezomib, and Rituximab in Patients With Previously Untreated Low Grade Lymphoma
NCT01029730 ·Status: COMPLETED ·Phase: PHASE2
-
Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma
NCT03761108 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Orelabrutinib Combined With Teniposide, Rituximab and Methotrexate for Newly Diagnosed PCNSL
NCT07185373 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2/PHASE3
-
Safety and Preliminary Efficacy Assessment of AZD7789 in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
NCT05216835 ·Status: COMPLETED ·Phase: PHASE1
-
First-in-Human (FIH) Trial of GEN3009 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas
NCT04358458 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
An Early Clinical Study Evaluating the Safety and Efficacy of AcNK-Sup003 Cell Injection in the Treatment of Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
NCT06693973 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
A Study of Brentuximab Vedotin, Rituximab, and Dose Attenuated CHP in Elderly Patients With Diffuse Large B-Cell Lymphoma (DLBCL)
NCT02734771 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Rituximab and Combination Chemotherapy in Treating Older Patients With Previously Untreated B-Cell Lymphoma
NCT00290667 ·Status: COMPLETED ·Phase: PHASE2
-
Odronextamab in Low Tumor Volume Advanced FL
NCT07128641 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of JNJ-87801493 in Combination With T-Cell Engagers in Participants With B-cell Non-Hodgkin Lymphoid (NHLs) Cancer
NCT06139406 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma
NCT03332017 ·Status: COMPLETED ·Phase: PHASE2
-
Azacitidine With Rituximab, Vincristine, and Cyclophosphamide in Refractory Lymphoma
NCT00901069 ·Status: COMPLETED ·Phase: PHASE1
-
Orelabrutinib, Rituximab and Combination Chemotherapy in Newly-diagnosed Aggressive B-cell Non-Hodgkin Lymphoma
NCT05097443 ·Status: UNKNOWN ·Phase: PHASE3