Trial Status: The Phase I/II study of A-dmDT390-bisFv(UCHT1) (Resimmune®) Fusion Protein in Patients with Cutaneous T-Cell Lymphoma has been completed. The Phase II Protocol is being readied for FDA submission.

This Phase II clinical trial is designed to treat patients with Cutaneous T-Cell Lymphoma (CTCL), with Stage never exceeding IB/IIB, mSWAT < 50%. CTCL patients with bone marrow involvement but without lymph node involvement are eligible. The drug Resimmune® consists of a toxin, called diphtheria toxin, which is attached to an antibody that can specifically target cancerous T-cells.

The Phase II portion of the trial objectives are to determine the preliminary efficacy the drug Resimmune®. Toxicities associated with the drug are also recorded. The safety and efficacy of the drug Resimmune® has not been established. A major exclusion to entering the trial is a past history of heart disease, or prior treatment with alemtuzumab (Campath) or similar agents or procedures that depress blood T cell counts to below 50% of the lower limit of normal.

Patients will receive full supportive care during the course of the study. Participation in the study will require IV infusions of the research agent 2 times a day for four days (protocol FDA outpatient approved), as well as frequent outpatient blood draws for the first 30 days. Patients with partial or complete remissions at their 1 month follow up visit will have another follow-up visit on day 60, then every three months for 1 year, followed by annual visits to assess duration of the response.

Identification of a Cutaneous T-Cell Lymphoma (CTCL) Subgroup Experiencing a High Treatment Response Rate1

An analysis based on the Clinical Response Data in May, 2015 of the Resimmune® clinical trial showed that there were 26 evaluable patients who received all 8 doses of Resimmune® varying between 2.5 and 11.25 ųg/kg per dose. There were responses at all the lower dose levels. The overall response rate was 38% and the complete response rate was 15% (when followed for six months). If we exclude patients who have mSWAT scores over 50 (50% of skin surface area times a multiplier) and who do not have lymph node involvement or stage III disease we are left with 10 patients. This subgroup has an Overall Response Rate (PR+CR) of 80% and a Complete Response (CR) rate of 40%, three of which are over 72 months duration and may represent cures (includes angioimmunoblastic T cell lymphoma). To our knowledge complete responses of this rate and lasting 5-6 years have not been previously reported in any patient treatment subgroup of CTCL with the possible exception of allogeneic HCT (Bloom et al., Curr Treat Options Oncol. 2012 Mar;13(1):102-21). There are advantages to treating patients in this subgroup of stage IB and IIB disease. First, the trade off between efficacy and safety is maximized in this subgroup compared to the larger population of all CTCL patients. Second, patients achieving long-term complete remissions experience benefits from freedom of unsightly painful skin lesions and out of pocket costs for expensive alternate systemic medications that can amount to $25,000 to $100,000 per year. Therefor we propose to focus on enrolling future patients in the Phase II portion of the trial who have characteristics of the high treatment response rate. This will provide additional safety and efficacy data at the established maximum tolerable treatment dose of 7.5 ųg/kg per dose.

Resimmune CTCL Patient Subgroup Experiencing a High Treatment Response Rate Resimmune Clinical Response Over Time for Responding CTCL Patients as Judged by mSWAT Scores Chart

Participate in Trials

New patients are being enrolled in the trials above. Please use the contact information and links provided to the right for contacting these centers directly.

Travel & Lodging Defrayment

Angimmune will partially defray travel & lodging costs for a family member to accompany a patient to this trial. Please contact the appropriate Clinical Research Coordinator at the trial site for more information.

1.) Presentation 2013 ASH Annual Meeting: Arthur E. Frankel, Jung H. Woo, Jeremy P. Mauldin, Francine M. Foss, Madeleine Duvic, David M. Neville Jr. "An Update On The Clinical Activity Of Resimmune, a Targeted Therapy Directed To CD3 Receptor, In Patients With Cutaneous T Cell Lymphomas—CTCL". Poster session presented at: American Society of Hematology (ASH). 55th ASH Annual Meeting and Exposition. 2013 December 7-10; New Orleans, LA.
Download the Poster PDF

† Patients with a diagnosis of angioimmunoblastic T cell lymphoma are eligible, even with lymph node involvement.