NCT06834373|RecruitingPhase 2DMCFDA Drug

Golcadomide and Rituximab as Bridging Therapy for Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma Before CAR T-cell Therapy

Phase 2 Study of Golcadomide With Rituximab as a Bridging Therapy Prior to CAR-T for Patients With Relapsed or Primary Refractory Aggressive B-Cell Non-Hodgkin Lymphoma (NHL)

Mayo Clinic ClinicalTrials.gov

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3 other identifiers

MC230813NCI-2025-0109424-005122

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredFeb 2025

StartedApr 2025

CompletionMar 2027

Brief Summary

This phase II trial tests the effectiveness of golcadomide and rituximab as bridging treatment before chimeric antigen receptor (CAR) T-cell therapy in patients with aggressive B-cell non-Hodgkin lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Patients that are able to receive CAR T-cell therapy have a potential for cure, however, many will not be qualified to receive therapy due to relapse. Bridging therapy is therapy intended to transition a patient from one therapy or medication to another or maintain their health or status until they are a candidate for a therapy or have decided on a therapy. Golcadomide may help block the formation, growth or spread of cancer cells. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving golcadomide and rituximab as bridging therapy before CAR T-cell therapy may kill more tumor cells and may improve the chance of proceeding to CAR T-cell therapy in patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

10mo left

Started Apr 2025

Geographic Reach

1 country

7 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.9 years study duration

Study Progress57%

Apr 2025Mar 2027

First Submitted

Initial submission to the registry

February 14, 2025

Completed

5 days until next milestone

First Posted

Study publicly available on registry

February 19, 2025

Completed

1 month until next milestone

Study Start

First participant enrolled

April 2, 2025

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2027

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

1.9 years

First QC Date

February 14, 2025

Last Update Submit

January 26, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

Disease control
Will be defined as a complete metabolic response (CMR), partial metabolic response (PMR), or no metabolic response (NMR) by Lugano 2014 PET-CT.
2 cycles (cycle length = 28 days)

Secondary Outcomes (9)

Disease control rate
Up to 2 years
Complete response rate
Up to 2 years
Overall response rate
Up to 2 years
The proportion of patients proceeding to chimeric antigen receptor T-cell (CART)
Up to 2 years
Overall response rate to CART
Up to 2 years
+4 more secondary outcomes

Study Arms (1)

Treatment (golcadomide, rituximab)

EXPERIMENTAL

Patients receive golcadomide PO QD on days 1-14 of each cycle and rituximab IV on days 1, 8, 15 and 22 of cycle 1 and then on day 1 of all subsequent cycles. Cycles repeat every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. ELIGIBLE FOR CAR-T: After 2 cycles, patients undergo leukapheresis and may receive 1-2 additional cycles of golcadomide and rituximab prior to undergoing standard of care CAR-T therapy. INELIGIBLE FOR CAR-T: After 2 cycles, patients receive golcadomide PO QD on days 1-14 of each cycle and rituximab IV on day 1 of each cycle. Cycles repeat every 28 days for up to 10 additional cycles of golcadomide (cycles 3-12) and up to 3 additional cycles of rituximab (cycles 3-5) in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and PET/CT or CT throughout the study. Additionally, patients may undergo bone marrow aspiration and biopsy as clinically indicated.

Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyBiological: Chimeric Antigen Receptor T-Cell TherapyProcedure: Computed TomographyDrug: GolcadomideProcedure: LeukapheresisProcedure: Positron Emission TomographyBiological: Rituximab