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A Phase 1, Dose-escalation Study of MEDI-551, a Humanized Monoclonal Antibody Directed Against CD19, in Adult Subjects With Relapsed or Refractory Advanced B-Cell Malignancies


Phase 1
18 Years
N/A
Open (Enrolling)
Both
B-cell Malignancies

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Trial Information

A Phase 1, Dose-escalation Study of MEDI-551, a Humanized Monoclonal Antibody Directed Against CD19, in Adult Subjects With Relapsed or Refractory Advanced B-Cell Malignancies


To determine the maximum tolerated dose (MTD) or optimal biologic dose (OBD) of MEDI-551 in
subjects with relapsed or refractory advanced B-cell malignancies.


Inclusion Criteria:



- Histologically confirmed CLL, DLBCL, FL;

- Karnofsky Performance Status ≥ 70;

- Life expectancy of ≥ 12 weeks;

- Prior radiation therapy provided exposure does not exceed an area of 25% of marrow
space

- Adequate hematological function

- Adequate organ function

Exclusion Criteria:

- Any available standard line of therapy known to be life-prolonging or life-saving;

- No concurrent therapy or therapy within six weeks of first dose of MEDI-551 for
treatment of cancer

- Previous therapy directed against CD19

- Vaccination (other than experimental cancer vaccine therapy) within 28 days prior to
receiving the first dose of MEDI-551;

- History of other invasive malignancy within 5 years except for cervical carcinoma in
situ (CIS), non-melanomatous carcinoma of the skin or ductal carcinoma in situ (DCIS)
of the breast that have been surgically cured;

- Active infection requiring treatment

- Autologous stem cell transplantation within 4 months prior to study entry;

- Allogeneic stem cell transplantation or any other organ transplant;

- Ongoing ≥ Grade 2 toxicities from previous cancer therapies unless specifically
allowed in the Inclusion/Exclusion criteria.

- Use of immunosuppressive medication other than steroids within 28 days before the
first dose of MEDI-551;

- Use of immunosuppressive medication other than steroids within 28 days before the
first dose of MEDI-551 (inhaled and topical corticosteroids are permitted);

- Documented current central nervous system involvement by leukemia or lymphoma;

- Pregnancy or lactation;

- Clinically significant abnormality on ECG.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the MTD or OBD of MEDI-551 in subjects with relapsed or refractory advanced B-cell malignancies and to determine the preliminary safety profile in these populations.

Outcome Time Frame:

Study Day 28

Safety Issue:

Yes

Principal Investigator

Trishna Goswami, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

MedImmune LLC

Authority:

United States: Food and Drug Administration

Study ID:

MI-CP204

NCT ID:

NCT00983619

Start Date:

June 2010

Completion Date:

August 2013

Related Keywords:

  • B-cell Malignancies
  • Cancer
  • Neoplasms

Name

Location

Research Site Alabaster, Alabama  
Research Site Anaheim, California  
Research Site Washington, District of Columbia  
Research Site Boca Raton, Florida  
Research Site Arlington Heights, Illinois  
Research Site Abilene, Texas  
Research Site Clarksburg, West Virginia