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NCT03670888

A Study to Compare the Bioequivalence and Safety of JHL1101 and Rituximab in CD20 Positive B Cell Lymphoma Patients

Terminated Phase 1 Last updated 9 January 2020
What this trial tests

Phase 1 trial testing JHL1101 in B Cell Lymphoma in 1 participant. Terminated before completion.

Timeline
16 November 2018
Primary endpoint
19 March 2019
19 March 2019

Quick facts

Lead sponsorJHL Biotech, Inc.
PhasePhase 1
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment1
Start date16 November 2018
Primary completion19 March 2019
Estimated completion19 March 2019
Sites2 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

JHL Biotech, Inc. — full company profile →

Who can join

Adults 18 to 75, any sex, with B Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicenter, randomized, double-blind, parallel group study to compare the PK, safety, tolerability, immunogenicity and PD of JHL1101 vs Rituxan in subjects with CD20-positive B cell lymphoma. The study duration is 13 weeks. Approximately 128 eligible subjects will be randomized in a 1:1 ratio to receive either JHL1101 (n=64) or Rituxan (n=64). Each subject will receive one intravenous (IV) infusions of the investigational product (IP) at the dose of 375mg/m2 on Day 1. Assessments of PK, safety, tolerability, immunogenicity, PD, and efficacy will be collected over the following 13-week period.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Biosimilar monoclonal antibodies for cancer treatment in adults.
    Galvao TF, Livinalli A, Lopes LC, Zimmermann IR, et al · · 2024 · cited 2× · PMID 39607013 · DOI 10.1002/14651858.cd013539.pub2

Verify or expand the search:

Other trials of JHL1101

Trials testing the same drug.

Other recruiting trials for B Cell Lymphoma

Currently open trials in the same condition.

Other JHL Biotech, Inc. trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03670888.

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