ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03530683
Recruitment Status : Recruiting
First Posted : May 21, 2018
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
Trillium Therapeutics Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Multicenter, open-label, phase 1a/1b Dose Escalation and Expansion Trial of TTI-622 in Patients with Advanced Relapsed or Refractory Lymphoma or Myeloma.

Condition or disease Intervention/treatment Phase
Lymphoma Myeloma Drug: TTI-622 Monotherapy Drug: TTI-622 + Rituximab Drug: TTI-622 + PD-1/PD-L1 Inhibitor Drug: TTI-622 + Proteasome-inhibitor Regimen Phase 1

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.


Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1a/1b Dose Escalation and Expansion Trial of TTI-622 in Patients With Advanced Relapsed or Refractory Lymphoma or Myeloma
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : August 20, 2020
Estimated Study Completion Date : April 22, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: TTI-622 Monotherapy
Escalation Phase will include multiple doses of TTI-622
 Drug: TTI-622 Monotherapy
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
Other Name: SIRPα-IgG4 Fc
Experimental: TTI-622 + Rituximab
Patients 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.
 Drug: TTI-622 + Rituximab
TTI-622 + Rituximab combination therapy.
Other Name: SIRPα-IgG4 Fc + Rituximab
Experimental: TTI-622 + PD-1/PD-L1 Inhibitor
Patients 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.
 Drug: TTI-622 + PD-1/PD-L1 Inhibitor
TTI-622 plus Nivolumab or Pembrolizumab combination therapy
Other Name: SIRPα-IgG4 Fc + PD-1/PD-L1 Inhibitor
Experimental: TTI-622 + Proteasome-Inhibitor Regimen
Patients 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.
 Drug: TTI-622 + Proteasome-inhibitor Regimen
TTI-622 plus a proteasome-inhibitor regimen (bortezomib plus dexamethasone or carfilzomib plus dexamethasone).
Other Name: SIRPα-IgG4 Fc + a Proteasome-inhibitor Regimen


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Frequency and severity of adverse events [ Time Frame: 36 ]
    To characterize the safety profile and dose-limiting toxicities (DLTs) of TTI-622.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03530683


Contacts
Contact: Andrew Marshall (416) 595-0627 ext 233 andrew@trilliumtherapeutics.com
Contact: Penka Petrova, PhD (416) 595-0627 ext 234 penka@trilliumtherapeutics.com

Locations
United States, Colorado
Colorado Blood Cancer Institute Recruiting
Denver, Colorado, United States, 80218
Contact: Stacey Gates       Stacey.gates@healthonecares.com   
United States, Michigan
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Silva Pregja    313-576-8673    pregjas@karmanos.org   
Sponsors and Collaborators
Trillium Therapeutics Inc.
Investigators
Study Director: Penka Petrova, PhD Trillium Therapeutics Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Trillium Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT03530683     History of Changes
Other Study ID Numbers: TTI-622-01
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Trillium Therapeutics Inc.:
Neoplasms
Lymphoma
Myeloma

Additional relevant MeSH terms:
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
 Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Rituximab
Immunoglobulin G
Proteasome Inhibitors
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action