Our lead programs, TTI-621 and TTI-622, are SIRPαFc decoy receptors designed to block the CD47 “do not eat” signal and activate both the innate and adaptive immune systems. Below please find a list of our current clinical trials.
A multicenter, open-label phase 1a/1b trial of intravenous TTI-621 in patients with relapsed or refractory hematologic malignancies.
A multicenter, open-label phase 1 trial of intratumoral TTI-621 in patients with relapsed and refractory percutaneously accessible solid tumors or mycosis fungoides (a form of cutaneous T cell lymphoma).
A two-part, multicenter, open-label, phase 1a/1b study of TTI-622 in patients with advanced relapsed or refractory lymphoma or multiple myeloma.
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TTI-621-01 (NCT02663518) is a multicenter, open-label phase 1a/b trial of TTI-621 in subjects with relapsed or refractory hematologic malignancies. The objectives of this study are to characterize the safety, tolerability, and pharmacokinetics of TTI-621, to determine MTD or the recommended dose/regimen, and to gain preliminary evidence of the anti-tumor activity of TTI-621. In this study TTI-621 is given as a 1 hour intravenous infusion once per week. Most patients on this study receive TTI-621 as a monotherapy in a variety of different hematological malignancies; it may be administered with rituximab in patients with CD20-positive lymphoma or in combination with the PD-1 checkpoint inhibitor nivolumab in patients with Hodgkin lymphoma.
Preliminary data from this study were recently reported at the 2017 American Society of Hematology Annual Meeting. Weekly infusions of TTI-621 were shown to be well tolerated in close to 100 patients reported. Transient thrombocytopenia was observed with no sequela of increased incidence of clinical bleeding. Hemoglobin levels was found stable on study, consistent with lack of RBC binding by TTI-621. Intravenous administration of TTI-621, particularly in combination with rituximab, resulted in objective responses in 5 out of 18 evaluable patients with heavily pre-treated, relapsed/refractory DLBCL, and several others experienced prolonged progression-free intervals.
This study is currently recruiting patients. For more information, including a list of trial locations, please refer to clinicaltrials.gov.
TTI-621-02 (NCT02890368) is a multicenter, open-label phase 1 trial of TTI-621 in patients with relapsed or refractory percutaneously accessible solid tumors or mycosis fungoides (a form of cutaneous T cell lymphoma). In this study TTI-621 is administered directly into the tumor (intratumoral dosing). Most patients on this study receive TTI-621 as a monotherapy; for some tumor types, TTI-621 may be administered with pegylated interferon-alpha, a PD-1/PD-L1 inhibitor, an oncolytic virus or radiation. The objectives of this study are to characterize the safety and tolerability of intratumoral TTI-621, to determine the recommended dose/regimen, and to gain preliminary evidence of the anti-tumor activity of TTI-621 following local administration. Detailed evaluation of serial, on-treatment tumor biopsies of both injected and non-injected cancer lesions will help characterize tumor microenvironment changes anticipated with CD47 blockade.
Preliminary data from this study were recently reported at the 2017 American Society of Hematology Annual Meeting. Intratumoral injection was well tolerated, with no dose-limiting toxicity observed. A rapid reduction in CAILS scores, which measures local lesion responses, was observed in 9 out of 10 mycosis fungoides patients and a reduction in circulating leukemic Sézary cells was observed in 3 out of 3 patients. Several patient profiles were presented which demonstrate clinical responses in disfiguring lesions, in some cases after a single dose of TTI-621.
This study is currently recruiting patients. For more information, including a list of trial locations, please refer to clinicaltrials.gov.
TTI-622-01 (NCT03530683) is a two-part, multicenter, open-label, phase 1a/1b study of TTI-622 in patients with advanced relapsed or refractory lymphoma or multiple myeloma. In the phase 1a dose-escalation part, patients are enrolled in sequential dose cohorts to receive TTI-622 once weekly to characterize safety, tolerability, pharmacokinetics, and to determine the maximum tolerated dose. In the phase 1b part, patients will be treated with TTI-622 in combination with rituximab in CD20+ lymphoma, a proteasome inhibitor-containing regimen in multiple myeloma, or a PD-1 inhibitor in classic Hodgkin’s lymphoma. Rituximab and proteasome inhibitors may provide additional “eat” signals that could enhance the efficacy of TTI-622. A PD-1 inhibitor may help amplify any anti-tumor T cell response generated by TTI-622.
This study is currently recruiting patients. For more information, including a list of trial locations, please refer to clinicaltrials.gov.