A-dmDT390-bisFv(UCHT1) Immunotoxin Therapy for Patients With Cutaneous T-Cell Lymphoma (CTCL)

Summary

This is a Phase II clinical trial aimed at treating a subgroup of patients with cutaneous T-cell lymphoma. The drug consists of a toxin, called diphtheria toxin, which is attached to an antibody that can specifically target cancerous T-cells. Our primary objectives are, therefore, to determine the patient subgroup with respect to disease burden who best responds to this experimental drug in treating CD3 positive T cell malignancies. We will be determining how the patient and their disease respond to this research agent.

The Clinical Response Data analysis from October 2014 done at the completion of the Phase I portion of A-dmT390-bisFv(UCHT1) fusion protein clinical trial showed that there were 25 evaluable patients who received all 8 doses varying between 2.5 and 11.25 µg/kg per dose. There were responses at all the lower dose levels up to 7.5 µg/kg per dose. The overall response rate was 36% and the complete response rate was 16% (when followed for 6 months). We have identified a subgroup of CTCL patients that have a very high response rate. If we exclude patients whose mSWAT scores never exceeded 50 (50% of skin surface area times a multiplier) and who never had lymph node involvement or stage III disease we are left with 9 patients. This subgroup has an overall response rate of 89% and a complete response rate of 50% (when followed for 6 months). Of these 4 patients currently in complete remission, three are long-term responders. Two are over 6 years in duration and one over 5 years duration. These may represent cures. The long time periods in the transition from partial response to complete response without treatment, 6 months to two years, suggests that the study drug in addition to exerting a direct killing effect on tumor also functions as an immunomodulator.

Conditions

• T-cell Lymphomas
• T-cell Leukemia
• Sezary Syndrome
• Mycosis Fungoides
• Cutaneous T-cell Lymphoma (CTCL)

Interventions

BIOLOGICAL

A-dmDT390-bisFv(UCHT1)

A-dmDT390-bisFv(UCHT1) will be administered as 60 μg/kg total given as 7.5 μg/kg/injection twice a day 4-6 hours apart for four consecutive days (days 1-4) into a free flowing IV over a period of approximately 15 minutes

Sponsors & Collaborators

• James Graham Brown Cancer Center

  collaborator OTHER

• M.D. Anderson Cancer Center

  collaborator OTHER

• Scott and White Hospital & Clinic

  collaborator OTHER

• University of Texas Southwestern Medical Center

  collaborator OTHER

• Yale University

  collaborator OTHER

• Angimmune LLC

  lead INDUSTRY

Principal Investigators

• Arthur E Frankel, MD · University of Texas Southwestern Medical Center

• Madeleine Duvic, MD · M.D. Anderson Cancer Center

• Cesar Rodriguez, MD · James Graham Brown Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-01-31

Primary Completion

2015-02-28

Completion

2016-11-30

Countries

• United States

Study Locations