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Monoclonal Antibodies
Maplirpacept + Standard Therapies for Blood Cancers (TTI-622-01 Trial)
Phase 1
Waitlist Available
Research Sponsored by Trillium Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate hepatic function
Pathologically confirmed relapsed/refractory diffuse large B-cell lymphoma (DLBCL) (Phase 1b Cohort D1 and D2)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 30 months
Awards & highlights
TTI-622-01 Trial Summary
This trial is testing an experimental medicine (TTI-622) to see if it's safe and effective for people with various types of blood cancers. The trial will be conducted in two parts, and participants may only participate in one part.
Who is the study for?
Adults with advanced blood cancers like lymphoma, leukemia, and multiple myeloma who've had their disease worsen after standard treatments can join. They need a tissue sample for research, good liver/kidney/blood function, and an ECOG score of 0-2 (which measures cancer patients' daily living abilities). People can't join if they've recently had other cancer drugs or major surgery, have brain involvement by the cancer, recent radiation therapy or stem cell transplant complications.Check my eligibility
What is being tested?
The trial is testing Maplirpacept alone in phase 1a to find a safe dose for those with relapsed/refractory lymphoma or multiple myeloma. In phase 1b it's combined with other anticancer meds for newly diagnosed AML or worsening diseases. The goal is to see if these combinations are safe and help reduce cancer growth.See study design
What are the potential side effects?
Possible side effects include reactions related to infusion through a vein such as fever or chills; organ inflammation; fatigue; changes in blood counts affecting clotting/immunity/anemia; digestive issues like nausea/vomiting; and potential impact on liver/kidney function.
TTI-622-01 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver is working well.
Select...
My diagnosis is relapsed or refractory diffuse large B-cell lymphoma.
Select...
I have recovered from side effects of past cancer treatments to mild or my normal level.
Select...
My kidneys are working well.
Select...
I have a new diagnosis of AML without TP53 mutations and am considered elderly or unfit for aggressive treatments.
Select...
My AML is newly diagnosed and has a TP53 mutation.
Select...
My multiple myeloma has come back or didn't respond to treatment.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I have available tumor tissue, either fresh or from previous tests.
Select...
My lymphoma has come back or didn't respond to treatment and I don't need blood transfusions.
Select...
My blood clotting function is normal.
Select...
My blood counts are within a healthy range.
TTI-622-01 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, up to 30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 30 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with response assessments that show preliminary efficacy
Phase 1a: Maximum Tolerated Dose (MTD)
Phase 1a: Number of AEs by Frequency
+7 moreSecondary outcome measures
Phase 1a: Duration of Response (DR)
Phase 1a: Incidence of anti-drug antibodies (ADA)
Phase 1a: Number of participants with disease control rate (DCR)
+13 moreTTI-622-01 Trial Design
7Treatment groups
Experimental Treatment
Group I: maplirpacept (PF-07901801) MonotherapyExperimental Treatment1 Intervention
In the phase 1a dose- escalation part for single-agent maplirpacept (PF-07901801), participants with Relapsing or Refractory (R/R) lymphoma will be enrolled in sequential dose cohorts to receive maplirpacept (PF-07901801) QW to characterize safety, tolerability, and PK; to determine the Maximum Tolerated Dose (MTD) or P1b Starting Dose (a dose lower than or equal to the single-agent MTD), and to gain preliminary evidence of antitumor activity.
In addition, participants with R/R Lymphoma may also be enrolled in a cohort to receive maplirpacept (PF-07901801) Q2W and a cohort to receive maplirpacept (PF-07901801) Q3W to characterize safety, tolerability, and PK; to determine the MTD; and to gain preliminary evidence of antitumor activity.
Group II: Cohort F1, F2 and F3: maplirpacept (PF-07901801) + isatuximab, carfilzomib and dexamethasoneExperimental Treatment4 Interventions
Cohort F1: participants with Relapsing or Recurrent (R/R) Multiple Myeloma (MM) will be treated with increasing doses of maplirpacept (PF-07901801) + isatuximab, carfilzomib and dexamethasone.
Cohort F2: participants with R/R MM will be treated with maplirpacept (PF-07901801) QW + isatuximab, carfilzomib and dexamethasone.
Cohort F3: participants with R/R MM will be treated with maplirpacept (PF-07901801) increased dose QW + isatuximab, carfilzomib and dexamethasone.
Group III: Cohort E1 and E2: single agent maplirpacept (PF-07901801)Experimental Treatment1 Intervention
Cohort E1: participants with Relapsing or Recurrent (R/R) Multiple Myeloma (MM) will be treated with single agent maplirpacept (PF-07901801) QW.
Cohort E2: participants with R/R MM will be treated with single agent maplirpacept (PF-07901801) increased dose QW.
Group IV: Cohort D1 and D2: maplirpacept (PF-07901801) + an anti-CD20 targeting agentExperimental Treatment2 Interventions
Cohort D1: participants with Relapsing or Recurrent (R/R) CD20+ Diffuse Large B Cell Lymphoma (DLBCL) will be treated with maplirpacept (PF-07901801) QW, then an increased dose Q3W + an anti-CD20 targeting agent.
Cohort D2: participants with R/R CD20+ DLBCL will be treated with maplirpacept (PF-07901801) dosed QW for 4 weeks, then an increased dose Q3W + an anti-CD20 targeting agent.
Group V: Cohort C1, C2 and C3: maplirpacept (PF-07901801) + Carfilzomib and DexamethasoneExperimental Treatment3 Interventions
Cohort C1: participants with Relapsing or Refractory (R/R) Multiple Myeloma (MM) will be treated with maplirpacept (PF-07901801) QW
+ carfilzomib and dexamethasone.
Cohort C2: participants with R/R MM will be treated with maplirpacept (PF-07901801) QW + carfilzomib and dexamethasone.
Cohort C3: participants with R/R MM will be treated with maplirpacept (PF-07901801) Q2W + carfilzomib and dexamethasone.
Group VI: Cohort B: maplirpacept (PF-07901801) + Azacitidine and VenetoclaxExperimental Treatment3 Interventions
Cohort B1: elderly or unfit participants with newly diagnosed TP53-wildtype AML will be treated with maplirpacept (PF-07901801) QW + azacitidine and venetoclax
Cohort B2: elderly or unfit participants with newly diagnosed TP53-wildtype AML will be treated with maplirpacept (PF-07901801) QW + azacitidine and venetoclax.
Group VII: Cohort A: maplirpacept (PF-07901801) + AzacitidineExperimental Treatment2 Interventions
Cohort A1: participants with newly diagnosed TP53-mutated Acute Myelocytic Leukemia (AML) will be treated with maplirpacept (PF-07901801) QW + azacitidine.
Cohort A2: participants with newly diagnosed TP53-mutated AML will be treated with maplirpacept (PF-07901801) QW + azacitidine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carfilzomib
2017
Completed Phase 3
~1440
Isatuximab
2016
Completed Phase 3
~370
Venetoclax
2019
Completed Phase 3
~1990
Dexamethasone
2007
Completed Phase 4
~2590
Azacitidine
2012
Completed Phase 3
~1440
Find a Location
Who is running the clinical trial?
Trillium Therapeutics, Inc., a Pfizer CompanyUNKNOWN
Trillium Therapeutics Inc.Lead Sponsor
6 Previous Clinical Trials
426 Total Patients Enrolled
PfizerLead Sponsor
4,567 Previous Clinical Trials
10,911,697 Total Patients Enrolled
47 Trials studying Lymphoma
5,724 Patients Enrolled for Lymphoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any experimental drugs or cancer treatments recently.I have not had major surgery in the last 30 days.My liver is working well.My diagnosis is relapsed or refractory diffuse large B-cell lymphoma.I haven't had a stem cell transplant in the last 3 months or have active graft-vs-host disease, except for mild skin issues.I have recovered from side effects of past cancer treatments to mild or my normal level.My kidneys are working well.I have a new diagnosis of AML without TP53 mutations and am considered elderly or unfit for aggressive treatments.My cancer has spread to my brain or spinal cord.My AML is newly diagnosed and has a TP53 mutation.My multiple myeloma has come back or didn't respond to treatment.I can take care of myself and am up and about more than half of my waking hours.I have available tumor tissue, either fresh or from previous tests.My lymphoma has come back or didn't respond to treatment and I don't need blood transfusions.I have not had radiation therapy in the last 14 days.My blood clotting function is normal.My blood counts are within a healthy range.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort F1, F2 and F3: maplirpacept (PF-07901801) + isatuximab, carfilzomib and dexamethasone
- Group 2: maplirpacept (PF-07901801) Monotherapy
- Group 3: Cohort A: maplirpacept (PF-07901801) + Azacitidine
- Group 4: Cohort B: maplirpacept (PF-07901801) + Azacitidine and Venetoclax
- Group 5: Cohort D1 and D2: maplirpacept (PF-07901801) + an anti-CD20 targeting agent
- Group 6: Cohort E1 and E2: single agent maplirpacept (PF-07901801)
- Group 7: Cohort C1, C2 and C3: maplirpacept (PF-07901801) + Carfilzomib and Dexamethasone
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available vacancies for subjects participating in this clinical trial?
"According to the clinicaltrials.gov database, this trial is still actively recruiting patients and was initially released on June 7th 2018 with its latest update coming November 9th 2022."
Answered by AI
Are there any other investigations that have been undertaken regarding TTI-622?
"TTI-622 was first assessed by the Manitoba Blood & Marrow Transplant Program CancerCare Manitoba in 2002. At this time, 1341 clinical trials related to TTI-622 have been finished while 885 are still running with many of these taking place at Ann Arbor, Michigan."
Answered by AI
What purpose does TTI-622 typically serve?
"Primarily prescribed to help manage ophthalmia, sympathetic, TTI-622 has also been known to be effective for complete blood count, induction chemotherapy and branch retinal vein occlusion."
Answered by AI
To what extent is this medical experiment being conducted with participants?
"Absolutely, according to clinicaltrials.gov the research study is still open for enrollment. Originally posted on June 7th 2018 and last edited November 9th 2022, this trial requires 476 volunteers across 42 medical sites."
Answered by AI
Has the United States Food and Drug Administration sanctioned TTI-622?
"The safety of TTI-622 is given a score of 1 since this initial phase trial has only limited evidence regarding its efficacy and security."
Answered by AI
How many North American locations are conducting this clinical trial?
"This clinical research is open for enrolment at the University of Michigan Hospitals in Ann Arbor, Norton Women & Children's Hospital in Louisville and Colorado Blood Cancer Institute situated in Denver. There are also 42 similar sites that can be found across the US."
Answered by AI
To what end is this research project oriented?
"According to the trial sponsor, Pfizer, the primary objective of this study is a 30-month examination into adverse events associated with TTI-622. In addition, secondary outcomes including its clearance combined with other treatments and single agent use, t1/2 when used in conjunction with approved anticancer medications or alone, and volume of distribution when mixed with selected therapies will be assessed."
Answered by AI
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