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A Combination of Rituximab and Varlilumab Immunotherapy in Patients with B-cell Lymphoma

NCT03307746 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-12-02

No results posted yet for this study

Summary

A total of 40 participants will be recruited, with 20 participants in each of the following subcategories:

A) High grade lymphoma (DLBCL, FL grade 3b, transformed FL) (n=20) B) Low grade lymphoma (e.g. FL grade 1, 2 or 3a, MZL, MCL) (n=20)

The main purpose for having two experimental treatment arms is to provide a comparator for the translational endpoints, i.e. to assess whether the differences observed are due to the addition of varlilumab to rituximab. The only difference between Arm A and Arm B is the delay in administration of varlilumab in cycle 1, which is on Day 2 in Arm A and Day 8 in Arm B. As the post-treatment tissue collection occurs on Day 7/8, prior to administration of varlilumab in Arm B, samples will be obtained from participants that have either been treated with rituximab alone, or both rituximab and varlilumab. To minimise any potential risks to the patient as a result of a repeat biopsy on Day 7/8, a prerequisite for entry to the trial is that the participants must have accessible sites for biopsy. Difference in response rates between Arm A and Arm B are not expected.

Conditions

  • B Cell Lymphoma

Interventions

DRUG

Varlilumab

Rituximab is a so-called direct-targeting mAb, which binds to the CD20 molecule on the surface of normal and malignant B cells. The mAb then engages immune effectors cells, such as macrophages, through Fc:Fc gamma receptor interaction, leading to tumour cell killing by antibody directed cellular cytotoxicity and/or phagocytosis (ADCC/ADCP). Varlilumab (1F5, CDX-1127) is a recombinant and fully human IgG1kappa mAb that binds to human CD27 with high affinity (62). As far as we are aware, it is the only anti-CD27 mAb in clinical development. Once bound, varlilumab blocks CD70 binding to CD27.

Sponsors & Collaborators

  • University Hospital Plymouth NHS Trust

    collaborator OTHER

  • The Christie NHS Foundation Trust

    collaborator OTHER

  • Oxford University Hospitals NHS Trust

    collaborator OTHER

  • Celldex Therapeutics

    collaborator INDUSTRY

  • Cancer Research UK

    collaborator OTHER

  • University Hospital Southampton NHS Foundation Trust

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-23
Primary Completion
2021-02-18
Completion
2024-08-21

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03307746 on ClinicalTrials.gov