Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2025-12-24 @ 2:39 PM
Study NCT ID:
NCT06854159
Status:
RECRUITING
Last Update Posted:
2025-09-29
First Post:
2025-02-25
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Odronextamab for the Treatment of Relapsed and Refractory Diffuse Large B-cell Lymphoma Before and After Chimeric Antigen Receptor T-cell Therapy
Sponsor:
Joseph Tuscano
Organization:
Study Overview
Official Title:
A Phase 2 Study of Odronextamab in Relapsed/ Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) Before and After Chimeric Antigen Receptor (CAR) T-Cell Therapy
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial tests how well odronextamab works before and after standard of care (SOC) chimeric antigen receptor (CAR) T-cell therapy in treating patients with diffuse large B-cell lymphoma (DLBCL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). CAR-T cell therapy is the SOC treatment most patients receive when other treatments have failed. CAR-T cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Odronextamab is a monoclonal antibody that is called bispecific, as it individually targets 2 cell proteins, CD20 and CD3. Proteins are part of each cell in the body, which work together like little machines for the cell to function. CD20 is a protein that is found on the surface of both normal B-cells and B-cells that make up certain cancers, like DLBCL. CD3 is a protein that is found on the surface of T cells. T-cells and normal B-cells are types of white blood cells in the body and are a part of the immune system that fights infections. Odronextamab is designed to help T-cells find and kill the B-cells including the cancer cells in DLBCL. Giving odronextamab before and after CAR T-cell therapy may improve response in patients with relapsed or refractory DLBCL.
Detailed Description:
PRIMARY OBJECTIVE:
I. To assess anti-tumor activity of odronextamab + CAR T-cell therapy in in patients with relapsed or refractory (R/R) DLBCL.
SECONDARY OBJECTIVES:
I. To evaluate the toxicities of odronextamab + CAR T-cell therapy in patients with R/R DLBCL.
II. To further assess anti-tumor activity of odronextamab + CAR T-cell therapy in patients with R/R DLBCL.
OUTLINE:
Patients receive odronextamab intravenously (IV) over 1-4 hours on days 1, 2, 8, 9, 15, and 16 of cycle 1, on days 1, 8, and 15 of cycles 2-4 then on days 1 and 15 of subsequent cycles until achievement of durable complete response (CR). Cycles repeat every 21 days in the absence of durable CR, disease progression, or unacceptable toxicity. Patients with durable CR for ≥ 9 months may then receive odronextamab IV over 1-4 hours on day 1 of each subsequent cycle. These cycles repeat every 28 days for up to a total of 2 years in the absence of disease progression or unacceptable toxicity. Patients receive SOC CAR T-cell therapy if disease assessment shows less than a CR after cycle 4, or after cycle 5 if disease assessment shows progressive disease (PD) any time after cycle 5. Additionally, patients undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) and blood sample collection, positron emission tomography (PET)/computed tomography (CT) or CT throughout the study. Patients may also undergo CT of the brain at screening.
After completion of study treatment, patients are followed up at 30 days then every 4 months for up to 2 years.
I. To assess anti-tumor activity of odronextamab + CAR T-cell therapy in in patients with relapsed or refractory (R/R) DLBCL.
SECONDARY OBJECTIVES:
I. To evaluate the toxicities of odronextamab + CAR T-cell therapy in patients with R/R DLBCL.
II. To further assess anti-tumor activity of odronextamab + CAR T-cell therapy in patients with R/R DLBCL.
OUTLINE:
Patients receive odronextamab intravenously (IV) over 1-4 hours on days 1, 2, 8, 9, 15, and 16 of cycle 1, on days 1, 8, and 15 of cycles 2-4 then on days 1 and 15 of subsequent cycles until achievement of durable complete response (CR). Cycles repeat every 21 days in the absence of durable CR, disease progression, or unacceptable toxicity. Patients with durable CR for ≥ 9 months may then receive odronextamab IV over 1-4 hours on day 1 of each subsequent cycle. These cycles repeat every 28 days for up to a total of 2 years in the absence of disease progression or unacceptable toxicity. Patients receive SOC CAR T-cell therapy if disease assessment shows less than a CR after cycle 4, or after cycle 5 if disease assessment shows progressive disease (PD) any time after cycle 5. Additionally, patients undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) and blood sample collection, positron emission tomography (PET)/computed tomography (CT) or CT throughout the study. Patients may also undergo CT of the brain at screening.
After completion of study treatment, patients are followed up at 30 days then every 4 months for up to 2 years.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-00900 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| UCDCC310 | OTHER | University of California Davis Comprehensive Cancer Center | View | |
| P30CA093373 | NIH | None | https://reporter.nih.gov/quic… | View |
| UCHMC2329 | OTHER | UC Hematologic Malignancies Consortium | View | |
| R1979-HM-2494 | OTHER_GRANT | Regeneron | View |