A Maintenance Extension of Phase I Pilot Study of Chimeric Anti-CD4 Antibody M-T412 in Patients With Multiple Sclerosis

This study has been completed.

First Received: February 24, 2000 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	National Center for Research Resources (NCRR) Stanford University
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004816

Purpose

OBJECTIVES: I. Evaluate the safety and immunogenicity of single and multiple doses of M-T412, a chimeric murine-human anti-CD4 monoclonal antibody, in patients with multiple sclerosis. II. Evaluate the pharmacokinetics of M-T412. III. Obtain preliminary data on the clinical response to M-T412.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: monoclonal antibody M-T412	Phase I

Study Type:	Interventional
Study Design:	Treatment, Open Label, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	25
Study Start Date:	July 1995

Detailed Description:

PROTOCOL OUTLINE: This is an open label, dose escalating study. Escalating doses of M-T412 are administered to cohorts of 5 patients each receiving a single dose intravenously over 2 hours.

Patients who complete the single dose assessment of M-T412 may receive up to 3 additional single doses of M-T412 IV over 2 hours, with each repeated dose given at least 1 month apart. Then, patients receive one dose level of M-T412 IV over 2 hours at 3 month intervals over a period of 12 months for a total of 5 doses. Once recovery of CD4 cells is obtained, the next scheduled infusion of M-T412 begins. Patients are omitted from study if CD4 cells remain attenuated following 2 scheduled infusion sessions. Patients are followed at 3, 6, 12, and 24 months after the first infusion.

Eligibility

Ages Eligible for Study:	21 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of chronic, advanced, progressive multiple sclerosis (MS)

--Prior/Concurrent Therapy--

Biologic therapy: No sensitivity to murine proteins No prior treatment at any time with anti-CD4 antibodies, other murine antibodies, or other anti-T cell antibodies (e.g., xenologous or human) At least 4 weeks since use of other biological agents
Chemotherapy: No concomitant chemotherapy At least 3 months since prior chemotherapy
Endocrine therapy: No concomitant steroidal therapy At least 3 months since prior steroidal therapy
Radiotherapy: No total lymphoid irradiation prior to study No concomitant radiotherapy At least 3 months since prior radiotherapy
Other: No use of investigational drugs within 30 days prior to study

--Patient Characteristics--

Age: 21 to 75
Hematopoietic: Hemoglobin at least 10 g/dL WBC at least 4000/mm3 Granulocyte count at least 1500/mm3 Platelet count at least 100,000/mm3 CD4+ lymphocyte count at least 300 cells/mm3
Other: Not pregnant or lactating Effective contraception required of fertile patients for 3 months prior to and during study No substance abuse (e.g., drug or alcohol) Not HIV positive No AIDS-Related Complex (ARC) No serum antibodies to HIV Negative serum antibody test for HIV within 1 month prior to study No underlying medical or psychiatric condition

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004816

Sponsors and Collaborators

National Center for Research Resources (NCRR)

Stanford University

Investigators

Study Chair:

Lawrence Steinman

Stanford University

More Information

No publications provided

Study ID Numbers:	199/12050, SUMC-C0128T03
Study First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004816 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

multiple sclerosis
neurologic and psychiatric disorders
rare disease

Study placed in the following topic categories:

Antibodies, Monoclonal
Antibodies
Autoimmune Diseases
Multiple Sclerosis
Immunologic Factors
Demyelinating Diseases

Mental Disorders
Rare Diseases
Demyelinating Autoimmune Diseases, CNS
Sclerosis
Autoimmune Diseases of the Nervous System
Immunoglobulins

Additional relevant MeSH terms:

Autoimmune Diseases
Demyelinating Diseases
Immune System Diseases
Immunologic Factors
Nervous System Diseases
Physiological Effects of Drugs
Sclerosis

Pharmacologic Actions
Antibodies, Monoclonal
Antibodies
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on July 02, 2009