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BI-1206 and an Anti-CD20 Antibody in Patients With CD32b Positive B-cell Lymphoma or Leukaemia

NCT02933320 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2021-07-08

Study results available
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Summary

The purpose of this trial is to identify the tolerable dose of BI-1206 (both alone and in combination) for patients with B-cell lymphoma and leukaemia and further evaluate BI-1206 alone and in combination with an anti-CD20 antibody.

Conditions

Interventions

BIOLOGICAL

BI-1206 single agent dose escalation phase

BI-1206 single agent dose escalation phase to determine the MTD or maximum administered dose (MAD) and recommended Phase II dose (RP2D) for evaluation of BI-1206.

BIOLOGICAL

Combination of BI-1206 with rituximab escalation phase

An investigation of combination treatment of BI-1206 with rituximab.

BIOLOGICAL

BI-1206 single agent expansion phase

BI-1206 single agent expansion phase at the RP2D.

BIOLOGICAL

Combination of BI-1206 with rituximab expansion phase

BI-1206 in combination with rituximab at the RP2D.

Sponsors & Collaborators

  • BioInvent International AB

    collaborator INDUSTRY

  • Bloodwise

    collaborator OTHER

  • Cancer Research UK

    lead OTHER

Principal Investigators

  • Andrew Davies, Prof · University of Southampton

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-27
Primary Completion
2020-03-19
Completion
2020-03-19

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
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 NCT02933320 on ClinicalTrials.gov