Study of Fc-Optimized Anti-CD19 Antibody (MOR00208) to Treat B-cell Acute Lymphoblastic Leukemia(B-ALL)

February 20, 2018 updated by: MorphoSys AG

A Phase IIa, Single-arm, Open-label Study of MOR00208, a Humanized Fc-Engineered Anti-CD19 Antibody, in Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia (B-ALL)

This is an open-label, multicentre study to characterize the safety and preliminary efficacy of the human anti CD19 antibody MOR00208 in adult subjects with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL)

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43201
        • Ohio State University Medical Center
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • St. Jude Children's Research Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas M.D. Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with previously treated Philadelphia-chromosome-negative B-ALL, with progression after at least one prior therapy. Patients with Philadelphia-chromosome-positive B-ALL can only be included if they are refractory or intolerant to at least one tyrosine-kinase-inhibitor.
  • Male or female patients at least 16 years of age; if the patient is less than 18 years of age, the patient must have the ability to understand and give written assent in addition to the parent's/guardian's written informed consent.
  • Patients with histologically confirmed diagnosis of B-ALL
  • Mixed phenotype acute leukemia patients who have B cell immunophenotype.
  • Patients with an Eastern Cooperative Oncology Group performance status of less than or equal to 2
  • Patients with a total bilirubin of less than or equal to 2.0 mg/dL
  • Patients with alanine aminotransferase or aspartate aminotransferase less than or equal to 2.5 times the upper limit of normal
  • Patients with a creatinine level of less than or equal to 2.0 mg/dL
  • If a female of childbearing potential, confirmation of a negative pregnancy test before enrollment and use of double-barrier contraception, confirmation of a negative pregnancy test before enrollment and use of oral contraceptive plus barrier contraceptive, or confirmation of having undergone clinically documented total hysterectomy, oophorectomy, or tubal ligation
  • If a male, use of an effective barrier method of contraception during the study and for 3 months after the last dose if sexually active with a female of childbearing potential
  • Patients with the ability to understand and give written informed consent and to comply with the study protocol

Exclusion Criteria:

  • Patients who received previous treatment with an anti-CD19 antibody or fragments
  • Receipt of anti-CD20 therapy no greater than 4 weeks before the first study dose
  • Patients having undergone prior allogeneic stem cell transplantation within 3 months or having active graft versus host disease
  • Patients with known hypersensitivity to any excipient contained in the drug formulation
  • Patients with a New York Heart Association Class III or IV
  • History of stroke or myocardial infarction within the last 6 months
  • Patients with a history of positive human immunodeficiency virus test result (ELISA or western blot)
  • Patients with positive hepatitis serology. Hepatitis B (HBV): Patients with positive serology for hepatitis B, defined as positive for hepatitis B surface antigen (HbsAg) or total anti-hepatitis B core antibody (anti-Hbc). Patients positive for anti- Hbc may be included if hepatitis B viral DNA is not detectable. Hepatitis C (HCV): Patients with positive hepatitis C serology (defined as positive for anti-hepatitis C virus antibody (anti-HCV) unless HCV-RNA is confirmed negative.
  • Patients with active viral, bacterial, or systemic fungal infection requiring active parenteral treatment
  • Patients who are receiving active treatment/chemotherapy for another primary malignancy or have received any treatment, including surgery, radiation, or chemotherapy, within the past 5 years (except ductal breast cancer in situ, for nonmelanoma skin cancer, prostate cancer not requiring treatment, and cervical carcinoma in situ)
  • Patients who are pregnant or breastfeeding
  • Patients with major surgery or radiation therapy within 4 weeks prior to first study dose

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MOR00208 (formerly Xmab5574)
intravenous Infusion of MOR00208, Fc-optimized Anti-CD19 Antibody
Drug: MOR00208 (formerly Xmab5574)
Other Names:
  • MOR208

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: Throughout during study until progression, after each treatment cycle

ORR= CR (Complete Remission) + PR (Partial Remission)

Antitumor activity of MOR00208
Throughout during study until progression, after each treatment cycle

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients Response Duration Evaluation by Hematology, Bone Marrow Aspirates or Biopsy, CT
Time Frame: Throughout during study until progression, after each treatment cycle
Two patients had a response to treatment. For one of the two patients a progression was recorded, the other patient was censored due to an AE. Conse quently, the planned Kaplan-Meier analyses of response duration and time to hematological relapse could not be calculated.
Throughout during study until progression, after each treatment cycle
Safety Will be Evaluated by Assessing Adverse Events, Clinical Lab Data and Vital Signs, ECG, Physical Exam
Time Frame: weekly, up to 7 months
Number of patients with at least one treatment-emergent AE
weekly, up to 7 months
Pharmacokinetics of MOR00208
Time Frame: weekly, up to 16 weeks, based on samples taken Pre-dose (ie before infusion start)
Steady State Trough Plasma Concentration (Cpre-dose) at 9th dose (infusion)
weekly, up to 16 weeks, based on samples taken Pre-dose (ie before infusion start)
Number of Patients Who Develop Ant-MOR00208 Antibodies as a Measure of Immunogenicity
Time Frame: monthly, up to 7 months
monthly, up to 7 months
Safety Will be Evaluated by Assessing Adverse Events, Clinical Lab Data and Vital Signs, ECG, Physical Exam
Time Frame: weekly, up to 7 months
Number of patients with treatment-emergent AEs
weekly, up to 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MorphoSys AG

Investigators

  • Principal Investigator: Elias Jabbour, MD, MDA
  • Principal Investigator: Rebecca Klisovic, MD, Ohio State University
  • Principal Investigator: Wing H. Leung, M.D., PhD, St. Jude Children's Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

September 3, 2012

First Submitted That Met QC Criteria

September 10, 2012

First Posted (Estimate)

September 13, 2012

Study Record Updates

Last Update Posted (Actual)

February 22, 2018

Last Update Submitted That Met QC Criteria

February 20, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOR208C202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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