Phase I Study of Subcutaneous Ocaratuzumab in Patients With Previously Treated CD20+ B-Cell Malignancies

Mentrik Biotech

Status and phase: Unknown; Phase 1

Conditions: Previously Treated CD20+ B-cell Malignancies

Treatments: Biological: ocaratuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01858181

MEN-001

Details and patient eligibility

About

Ocaratuzumab is a third-generation, fully humanized IgG1 monoclonal antibody (mAb) targeting the CD20 surface marker on normal and malignant B lymphocytes. It has been optimized for an increased binding for CD20 and an enhanced antibody dependent cell medicated cytotoxicity (ADCC) effector function.

A previous phase I/II study of intravenously (IV) administered ocaratuzumab in refractory/relapsed follicular lymphoma patients has concluded that ocaratuzumab is safe and well-tolerated at doses up to 375mg/ m2 weekly for four weeks.

In this proposed phase I study, ocaratuzumab will be administered subcutaneously to patients with previously treated CD20+ B-cell malignancies. Three dose levels (40 mg weekly x 4 doses, 80 mg weekly x 4 doses, and 80 mg weekly x 8 doses) will be investigated for safety, tolerability, pharmacokinetic, and pharmacodynamic analyses.

Enrollment: 9 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >18 years;

• Histologically confirmed diagnosis of a CD20+ B-cell malignancy;

• Received at least one prior treatment regimen;historically documented CD20-positivity is acceptable;

• Appropriate for single agent study drug therapy as prescribed by this protocol;

• ECOG performance status 0 to 2;

• Adequate hematopoietic, renal, and hepatic functions defined as:

  • Absolute neutrophil count greater than 1000 /mm³
  • Platelet count greater than 75,000/mm³
  • Hemoglobin greater than 8.5 g/dL
  • Serum creatinine ≤ 1.5x upper limit of normal
  • AST, ALT, and total bilirubin ≤ 3x upper limit of normal;

• Ability to understand and the willingness to sign a written informed consent document;

• Life expectancy of 6 months or greater.

Exclusion criteria

• Anti-CD20 therapy within 4 weeks of enrollment;
• Systemic chemotherapy or immunotherapy within 14 days of enrollment;
• Chronic systemic steroid therapy defined as prednisone or equivalent 10 mg/day or greater;
• Systemic cytotoxic or immunosuppressive therapy to be administered concomitantly while participating on this study;
• Active infection, chronic or severe infection requiring ongoing antimicrobial therapy.
• Positivity for hepatitis B (defined as HepBs Antigen +), hepatitis C (defined as HepC Antibody +), or HIV; HIV positive patients on antiretroviral therapy will be excluded;
• History of allergic reactions attributed to compounds of similar chemical or biologic composition;
• Significant cardiac disease (New York Heart Association classes III or IV) or unstable angina despite medication;
• Women who are pregnant or breast-feeding;
• Women of child bearing potential who are unwilling to use effective contraception for the duration of the study drug administration and 6 months after final dose of drug is administered;
• Psychiatric illness/social situations that would limit compliance with study requirements;
• Participation in other investigational studies while enrolled on this trial.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

9 participants in 3 patient groups

Cohort 1

Experimental group

Description:

SC ocaratuzumab 40 mg weekly x 4 doses

Treatment:

Biological: ocaratuzumab

Cohort 2

Experimental group

Description:

SC ocaratuzumab 80 mg weekly x 4 doses

Treatment:

Biological: ocaratuzumab

Cohort 3

Experimental group

Description:

SC ocaratuzumab 80 mg weekly x 8 doses

Treatment:

Biological: ocaratuzumab