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



Status:Recruiting
Conditions:Blood Cancer, Lymphoma, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:3/21/2019
Start Date:May 1, 2018
End Date:April 22, 2021
Contact:Andrew Marshall, BSc, MMSc
Email:andrew@trilliumtherapeutics.com
Phone:(416) 595-0627

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

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

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.

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.
We found this trial at
7
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Washington, District of Columbia 20007
Phone: 202-784-0038
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4100 John R
Detroit, Michigan 48201
800-527-6266
Phone: 313-576-8673
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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1721 East 19th Ave., Suite #200 & #300
Denver, Colorado 80218
720-754-4800
Colorado Blood Cancer Institute When patients come to the Colorado Blood Cancer Institute, the entire...
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Houston, Texas 77030
Phone: 713-792-2806
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Miami Lakes, Florida 33014
Phone: 786-362-5763
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Seattle, Washington 98104
Phone: 206-215-2363
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