What side effects are associated with this type of intervention?

Common treatments for lymphoma, including chemotherapy, targeted therapy, and immunotherapy, often have a range of side effects. Chemotherapy can cause fatigue, nausea, vomiting, hair loss, and increased risk of infections due to lowered blood cell counts. Targeted therapies, such as ibrutinib, may lead to diarrhea, fatigue, and hematologic toxicities like anemia and thrombocytopenia. Immunotherapies, including monoclonal antibodies like rituximab, can cause infusion reactions, fever, chills, and increased risk of infections. These side effects vary in severity and frequency depending on the specific treatment regimen and individual patient factors.

What prior FDA approvals exist?

Several FDA-approved drugs for the treatment of lymphoma include ibrutinib, which is used as a single-agent therapy for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), and rituximab, often combined with other agents like bendamustine for various types of lymphoma. These drugs are designed to target and reduce cancer growth, similar to the investigational agent maplirpacept (PF-07901801). Additionally, CAR-T cell therapies such as brexucabtagene autoleucel have shown efficacy in relapsed or refractory mantle cell lymphoma, achieving durable remissions in many patients.

What other types of research exist?

Promising novel alternatives to Maplirpacept (PF-07901801) for lymphoma patients include: 1) Venetoclax, a BCL-2 inhibitor, which has shown efficacy in combination with other agents in relapsed/refractory lymphoma. 2) CAR T-cell therapies, such as axicabtagene ciloleucel and tisagenlecleucel, which have demonstrated significant responses in aggressive lymphomas. 3) Bispecific T-cell engagers (BiTEs) like blinatumomab, which target CD19 on B-cells and have shown activity in B-cell lymphomas. 4) Immune checkpoint inhibitors, such as pembrolizumab and nivolumab, which have been effective in certain subtypes of lymphoma. These alternatives are based on recent clinical trial data and emerging therapies expected to be relevant in 2024.

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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)

Must not have

Known, current central nervous system disease involvement

Subjects who have undergone radiation therapy within 14 days of study treatment administration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 30 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new medicine called maplirpacept (PF-07901801) for adults with certain blood cancers that have not responded to other treatments. The medicine is given through a vein and aims to attack cancer cells. The study will see how safe and effective it is when used alone or with other cancer medicines.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver is working well.

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My diagnosis is relapsed or refractory diffuse large B-cell lymphoma.

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My AML is newly diagnosed and has a TP53 mutation.

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I can take care of myself and am up and about more than half of my waking hours.

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I have available tumor tissue, either fresh or from previous tests.

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My lymphoma has come back or didn't respond to treatment and I don't need blood transfusions.

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My blood clotting function is normal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to my brain or spinal cord.

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I have not had radiation therapy in the last 14 days.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 30 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with response assessments that show preliminary efficacy

Phase 1a: Maximum Tolerated Dose (MTD)

Phase 1a: Number of AEs by Frequency

+7 more

Secondary study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1430

Isatuximab

2016

Completed Phase 3

~370

Venetoclax

2019

Completed Phase 3

~2200

Dexamethasone

2007

Completed Phase 4

~2650

Azacitidine

2012

Completed Phase 3

~1440

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for lymphoma include chemotherapy, targeted therapy, immunotherapy, and radiation therapy. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cancer cells. Targeted therapy, such as monoclonal antibodies and small molecule inhibitors, specifically targets cancer cell markers or pathways critical for cancer cell survival and proliferation. Immunotherapy, including checkpoint inhibitors and CAR T-cell therapy, enhances the body's immune response against cancer cells. Radiation therapy uses high-energy radiation to destroy cancer cells. For lymphoma patients, these treatments are crucial as they aim to reduce tumor burden, achieve remission, and improve survival rates. Treatments like maplirpacept (PF-07901801) are particularly significant as they represent novel approaches to inhibit cancer growth, potentially offering new hope for patients with relapsed or refractory lymphoma.

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