Completed
A Phase 1 Study Of Cmc-544 Administered As A Single Agent In Subjects With B-cell Non- Hodgkin's Lymphoma
What is being tested
Inotuzumab ozogamicin [CMC-544]
Drug
Who is being recruted
Hemic and Lymphatic Diseases+7
+ Immune System Diseases
+ Immunoproliferative Disorders
From 18 to 99 Years
+8 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Study Start: August 2003
Summary
Principal SponsorPfizer
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 2003
Actual date on which the first participant was enrolled.To determine the Maximum Tolerated Dose (MTD), the tolerability, and the initial safety profile of CMC-544 in subjects with B-cell Non-Hodgkin's Lymphoma (NHL).
Official TitleA Phase 1 Study Of Cmc-544 Administered As A Single Agent In Subjects With B-cell Non- Hodgkin's Lymphoma
Principal SponsorPfizer
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
79 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 99 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphomaLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeLymphoma, B-Cell
Criteria
5 inclusion criteria required to participate
Subjects who have been previously diagnosed with CD22-positive, B-cell NHL, according to WHO classification, which has progressed after at least 2 prior therapies of probable clinical benefit
At the expanded cohort, part 2 of the study, subjects must have one of the following:
Follicular lymphoma previously treated with at least one dose of rituximab, but have not received radioimmunotherapy
Diffuse large B-cell lymphoma
Show More Criteria
3 exclusion criteria prevent from participating
Candidate for potentially curative therapies in the opinion of the investigator
Chronic lymphocytic leukemia
Burkitt's lymphoma, primary effusion lymphoma, and precursor B-cell lymphoblastic lymphoma
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalInotuzumab ozogamicin, iv, dose escalation and expanded cohort at 1.8mg/m2
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 22 locations
Suspended
UAB CCC Clinical Studies Unit
Birmingham, United StatesOpen UAB CCC Clinical Studies Unit in Google MapsSuspended
University of Alabama at Birmingham Kirklin Clinic
Birmingham, United StatesSuspended
UAB Russell Ambulatory Pharmacy
Birmingham, United StatesSuspended
University of Alabama at Birmingham
Birmingham, United StatesCompleted22 Study Centers