A Trial of TTI-622 in Patients With Advanced Hematologic Malignancies (TTI-622-01)

  • End date
    Jun 30, 2024
  • participants needed
  • sponsor
    Trillium Therapeutics Inc.
Updated on 8 June 2022
hematologic malignancy
multiple myeloma
diffuse large b-cell lymphoma
b-cell lymphoma
refractory lymphoma
large b-cell lymphoma
refractory multiple myeloma


Multicenter, open-label, phase 1a/1b Dose Escalation and Expansion Trial of TTI-622 in subjects with Advanced Hematologic Malignancies, Including Lymphoma, Leukemia, and Multiple Myeloma.


This is a trial of TTI-622 in subjects with relapsed or refractory lymphoma or multiple myeloma (MM) and subjects with newly diagnosed acute myeloid leukemia (AML).

This trial will be conducted in 2 phases: Phase 1a (Dose-Escalation Phase for Single-Agent TTI-622) and Phase 1b (TTI-622 Combinations and Single-Agent).

In the Dose-Escalation Phase for Single-Agent TTI-622, subjects with relapsed or refractory lymphoma will be enrolled in sequential dose cohorts.

In the Combination and Single-Agent Treatment part, subjects will be included in 1 of 9 cohorts: (Cohort A) subjects with newly diagnosed TP53-mutated AML will be treated with TTI-622 + azacitidine; (Cohort B) elderly subjects (≥75 years old) or subjects unfit for intensive induction chemotherapies with newly diagnosed TP53-wildtype AML will be treated with TTI-622 + azacitidine and venetoclax; (Cohort C1, C2, and C3) subjects with relapsed or refractory MM will be treated with TTI-622 + carfilzomib and dexamethasone; (Cohort D1 and D2) subjects in relapsed or refractory CD20+ diffuse large B-cell lymphoma will be treated with TTI-622 + an anti-CD20 targeting agent; and (Cohort E1 and E2) subjects with relapsed refractory MM will be treated with single-agent TTI-622.

Condition Lymphoma, Multiple Myeloma, Acute Myeloid Leukemia, Diffuse Large B-Cell Lymphoma
Treatment Dexamethasone, Azacitidine, Carfilzomib, venetoclax, TTI-622 Monotherapy, TTI-622 + Rituximab, TTI-622 + PD-1/PD-L1 Inhibitor, TTI-622 + Proteasome-inhibitor Regimen, TTI-622 + PD-1 Inhibitor, TTI-622, anti-CD20 Targeting agent
Clinical Study IdentifierNCT03530683
SponsorTrillium Therapeutics Inc.
Last Modified on8 June 2022


Yes No Not Sure

Inclusion Criteria

Available fresh or archived tumor tissue
Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
Adequate hematologic status
Adequate coagulation function
Adequate hepatic function
Adequate renal function
Recovery from non-hematopoietic toxicities of previous anticancer drugs or radiotherapy or previous surgeries to ≤Grade 1 (or to baseline grade if condition was pre-existing)
Key Inclusion Criteria (Phase 1a): Histologically confirmed relapsed/refractory lymphoma
(Hodgkin or non-Hodgkin)
Key Inclusion Criteria (Phase 1b Cohort A): Histologically confirmed, newly diagnosed
TP53-mutated Acute Myeloid Leukemia (AML)
Key Inclusion Criteria (Phase 1b Cohort B): Histologically confirmed, newly diagnosed
TP53-wildtype AML, elderly or unfit for more aggressive treatment
Key Inclusion Criteria (Phase 1b Cohorts C and E): Histologically documented
relapsed/refractory Multiple Myeloma (MM)
Key Inclusion Criteria (Phase 1b Cohort D): Pathologically confirmed relapsed/refractory
diffuse large B-cell lymphoma (DLBCL)

Exclusion Criteria

Known, current central nervous system disease involvement
Use of any investigational agent or any anticancer drug within 14 days before planned
start of study treatment (within 4 weeks for antibody-based therapies and within 8
weeks for cell-based therapies)
Subjects who have undergone radiation therapy within 14 days of study treatment
Major surgery within 30 days before planned start of study treatment
Hematopoietic stem cell transplant within 90 days before the planned start of study
treatment or subjects with active graft-vs-host disease, with the exception of Grade 1
skin involvement
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