Clinical Trials /

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

NCT03530683

Description:

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

Related Conditions:
  • Classical Hodgkin Lymphoma
  • Hodgkin Lymphoma
  • Lymphoma
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Trial of TTI-622 in Patients With Advanced Relapsed or Refractory Lymphoma or Myeloma
  • Official Title: A Phase 1a/1b Dose Escalation and Expansion Trial of TTI-622 in Patients With Advanced Relapsed or Refractory Lymphoma or Myeloma

Clinical Trial IDs

  • ORG STUDY ID: TTI-622-01
  • NCT ID: NCT03530683

Conditions

  • Lymphoma
  • Myeloma

Interventions

DrugSynonymsArms
TTI-622 MonotherapySIRPα-IgG4 FcTTI-622 Monotherapy
TTI-622 + RituximabSIRPα-IgG4 Fc + RituximabTTI-622 + Rituximab
TTI-622 + PD-1/PD-L1 InhibitorSIRPα-IgG4 Fc + PD-1/PD-L1 InhibitorTTI-622 + PD-1/PD-L1 Inhibitor
TTI-622 + Proteasome-inhibitor RegimenSIRPα-IgG4 Fc + a Proteasome-inhibitor RegimenTTI-622 + Proteasome-Inhibitor Regimen

Purpose

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

Detailed Description

      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.
    

Trial Arms

NameTypeDescriptionInterventions
TTI-622 MonotherapyExperimentalEscalation Phase will include multiple doses of TTI-622
  • TTI-622 Monotherapy
TTI-622 + RituximabExperimentalPatients with CD20 positive lymphoma may enter the TTI-622 + rituximab combination cohort; rituximab administered according to the institutional standard of care in accordance with the current FDA-approved package insert.
  • TTI-622 + Rituximab
TTI-622 + PD-1/PD-L1 InhibitorExperimentalPatients with classic Hodgkin Lymphoma may enroll in this cohort and will receive TTI-622 in combination with either nivolumab administered per institutional standard of care in accordance with the current FDA-approved package insert or pembrolizumab administered per institutional standard of care in accordance with the current FDA-approved package insert.
  • TTI-622 + PD-1/PD-L1 Inhibitor
TTI-622 + Proteasome-Inhibitor RegimenExperimentalPatients with myeloma will receive TTI-622 in addition to a standard NCCN guideline recommended proteasome inhibitor (either bortezomib or carfilzomib) + dexamethasone-containing regimen administered per institutional standard of care in accordance with the current FDA-approved package insert.
  • TTI-622 + Proteasome-inhibitor Regimen

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Frequency and severity of adverse events
Time Frame:36
Safety Issue:
Description:To characterize the safety profile and dose-limiting toxicities (DLTs) of TTI-622.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Trillium Therapeutics Inc.

Trial Keywords

  • Neoplasms
  • Lymphoma
  • Myeloma

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