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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 : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Trillium Therapeutics Inc.

Study Description
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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 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 (DLBCL or iNHL), classic Hodgkin lymphoma and Myeloma, in combination with other anti-cancer drugs, to further define safety and to characterize efficacy.

Study Design
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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


Arms and Interventions
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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 in DLBCL
Patients with CD20 positive diffuse large B-cell 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 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.
 Drug: TTI-622 + PD-1 Inhibitor
TTI-622 plus Nivolumab 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 (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 (carfilzomib plus dexamethasone).
Other Name: SIRPα-IgG4 Fc + a Proteasome-inhibitor Regimen
Experimental: TTI-622 + Rituximab in iNHL
Patients with CD20 positive indolent NHL 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


Outcome Measures
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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
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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
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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
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Contact: Kathleen Roberge, NP-C, MSc (857)412-7029 ext 211 kathleen@trilliumtherapeutics.com
Contact: Yaping Shou, MD, PhD yaping@trilliumtherapeutics.com

Locations
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United States, Colorado
Colorado Blood Cancer Institute Recruiting
Denver, Colorado, United States, 80218
Contact: Stacey Gates       Stacey.gates@healthonecares.com   
United States, District of Columbia
Georgetown Lombardi Comprehensive Cancer Center Recruiting
Washington, District of Columbia, United States, 20057
Contact: Pari Ramzi, RN,MSN    202-784-0038    ramzip1@georgetown.edu   
United States, Florida
Lakes Research Recruiting
Miami Lakes, Florida, United States, 33014
Contact: Yamile Sanchez    786-362-5763    ysanchez@lakesresearch.com   
United States, Michigan
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Silva Pregja    313-576-8673    pregjas@karmanos.org   
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Tala Shekarkt    646-449-1351    shekarkt@mskcc.org   
United States, Ohio
Gabrail Cancer Center Research, LLC Recruiting
Canton, Ohio, United States, 44718
Contact: Kirstie Armstrong       karmstrong@gabrailcancercenter.com   
United States, Tennessee
University of TN Medical Center/Cancer Institute Recruiting
Knoxville, Tennessee, United States, 37920
Contact: Radhakrishnan Ramchandren, MD    865-305-8780    mailto:rramchandren@utmck.edu   
Contact: Emily Byers, RN    865-305-7136    ebyers@utmck.edu   
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Alyssa Sheffield, BSN, RN, OCN    713-792-2806    AGSheffield@mdanderson.org   
Contact: Deborah Davis, RN    713-792-3850    dldavis@mdanderson.org   
United States, Washington
Swedish Cancer Institute - Research Recruiting
Seattle, Washington, United States, 98104
Contact: Ngan Trinh    206-215-2363    Ngan.Trinh@swedish.org   
Contact: Neil Bailey       Neil.Bailey@swedish.org   
Sponsors and Collaborators
Trillium Therapeutics Inc.
Investigators
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Study Director: Yaping Shou, MD, PhD Trillium Therapeutics Inc.
More Information
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Responsible Party: Trillium Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT03530683    
Other Study ID Numbers: TTI-622-01
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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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, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action