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

Brief Title

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


Brief Summary

      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.
    

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.
    

Study Phase

Phase 1

Study Type

Interventional




Condition

Multiple Sclerosis

Intervention

monoclonal antibody M-T412


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

25

Start Date

July 1995



Eligibility 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
      

Gender

All

Ages

21 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Lawrence Steinman, , 



Administrative Informations


NCT ID

NCT00004816

Organization ID

199/12050

Secondary IDs

SUMC-C0128T03


Study Sponsor

National Center for Research Resources (NCRR)

Collaborators

 Stanford University

Study Sponsor

Lawrence Steinman, Study Chair, Stanford University


Verification Date

December 2001