A Trial of TTI-622 in Patients With Advanced Relapsed or Refractory Lymphoma or Myeloma (TTI-622-01)

Multicenter, open-label, phase 1a/1b Dose Escalation and Expansion Trial of TTI-622 in Patients with Advanced Relapsed or Refractory Lymphoma or Myeloma.

This is a trial of TTI-622 in subjects with relapsed or refractory lymphoma or myeloma.

TTI-622 (SIRPα-IgG4 Fc), is a soluble recombinant fusion protein created by directly linking the sequences encoding the N-terminal CD47 binding domain of human SIRPα with the Fc domain of human immunoglobulin (IgG4). TTI-622 acts by binding human CD47 and preventing it from delivering an inhibitory "do not eat" (anti phagocytic) signal to macrophages.

This trial will be conducted in 2 phases: Phase 1a (Dose-escalation phase) and Phase 1b (Expansion Combination Treatment).

In the Dose-escalation Phase (phase 1a), subjects with lymphoma will be enrolled in sequential dose cohorts to receive TTI-622 to characterize safety, tolerability, pharmacokinetics, and the maximum-tolerated dose (MTD).

In the Combination Treatment Phase (phase 1b), TTI-622 will be given to subjects with CD20-positive lymphoma, classic Hodgkin lymphoma and Myeloma, in combination with other anti-cancer drugs, to further define safety and to characterize efficacy.

May 02, 2019
Cancer, Cancer (Heme) - Lymphoma - Diffuse Large B Cell, Cancer (Heme) - Lymphoma - Hodgkin, Cancer (Hematology) - Multiple Myeloma / Plasma Cell Malignancies
Krish Patel, MD
Trillium Therapeutics Inc.

Swedish Cancer Institute

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Relapsed or refractory hematologic malignancy (lymphoma or multiple myeloma) that has progressed, or is currently progressing with standard anticancer therapy or for which no other approved therapy exist. Lymphoma patients must have failed at least 2 standard anticancer therapies, and multiple myeloma patients must have failed at least 3 standard anticancer therapies.
  2. Advanced measurable malignancy
  3. Adequate hematologic status
  4. Adequate coagulation function
  5. Adequate hepatic function
  6. Adequate renal function

Exclusion Criteria:

  1. Known, current central nervous system disease involvement or untreated brain metastases
  2. Hematopoietic cell transplant or other cellular based therapy within 30 days before the planned start of study treatment or patients with active graft-vs-host disease with the exception of Grade 1 skin involvement
  3. History of hemolytic anemia or bleeding diathesis or positive direct antiglobulin test.

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