A Trial of TTI-622 in Patients With Advanced Relapsed or Refractory Lymphoma or Myeloma (TTI-622-01)
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| ClinicalTrials.gov Identifier: NCT03530683 |
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Recruitment Status :
Recruiting
First Posted : May 21, 2018
Last Update Posted : October 26, 2018
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Sponsor:
Trillium Therapeutics Inc.
Information provided by (Responsible Party):
Trillium Therapeutics Inc.
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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/PD-L1 Inhibitor Drug: TTI-622 + Proteasome-inhibitor Regimen | Phase 1 |
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 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
Genetics Home Reference related topics:
Multiple myeloma
Drug Information available for:
Rituximab
| Arm | Intervention/treatment |
|---|---|
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Experimental: TTI-622 Monotherapy
Escalation Phase will include multiple doses of TTI-622
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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 |
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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.
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Drug: TTI-622 + Rituximab
TTI-622 + Rituximab combination therapy.
Other Name: SIRPα-IgG4 Fc + Rituximab |
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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.
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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 |
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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.
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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 |
Primary Outcome Measures :
- Frequency and severity of adverse events [ Time Frame: 36 ]To characterize the safety profile and dose-limiting toxicities (DLTs) of TTI-622.
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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:
- 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.
- Advanced measurable malignancy
- Adequate hematologic status
- Adequate coagulation function
- Adequate hepatic function
- Adequate renal function
Exclusion Criteria:
- Known, current central nervous system disease involvement or untreated brain metastases
- 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
- History of hemolytic anemia or bleeding diathesis or positive direct antiglobulin test.
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, BSc, MMSc | (416) 595-0627 ext 233 | andrew@trilliumtherapeutics.com | |
| Contact: Yaping Shou, MD, PhD | yaping@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, District of Columbia | |
| Georgetown Lombardi Comprehensive Cancer Center | Not yet recruiting |
| Washington, District of Columbia, United States, 20057 | |
| Contact: Pari Ramzi, RN ,MSN 202-784-0038 ramzip1@georgetown.edu | |
| 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, Ohio | |
| Gabrail Cancer Center Research, LLC | Recruiting |
| Canton, Ohio, United States, 44718 | |
| Contact: Kirstie Armstrong karmstrong@gabrailcancercenter.com | |
Sponsors and Collaborators
Trillium Therapeutics Inc.
Investigators
| Study Director: | Yaping Shou, MD, PhD | Trillium Therapeutics Inc. |
| 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: | October 26, 2018 |
| Last Verified: | October 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.:
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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 Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |