The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.

Clinical Trial Details

Geo Regions

Category

Hematological Malignancies

Maplirpacept (SIRPα-IgG4 Fusion Protein)

Maplirpacept (TTI-622/PF-07901801) is an investigational compound. Its safety and efficacy have not been established.

A PHASE 1b/2, OPEN-LABEL STUDY OF PF-07901801 IN COMBINATION WITH GLOFITAMAB AFTER A FIXED, SINGLE DOSE OF OBINUTUZUMAB IN PARTICIPANTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B CELL LYMPHOMA NOT ELIGIBLE FOR STEM CELL TRANSPLANTATION
Phase 1 /2
NCT05896163

Active enrolling

Globe
Locations

United States, Israel, Japan, Taiwan

Study design

Participant Group/Arm

EXPERIMENTAL: Phase 1b

Participants will be allocated to sequential dose levels of PF-07901801, administered in combination with fixed doses of glofitamab after a dose of obinutuzumab, to select two doses of PF-07901801 for further evaluation in Phase 2. Approximately 20 participants will be enrolled.

Intervention/Treatment

DRUG: maplirpacept (PF-07901801)

Intravenous infusion

DRUG: Glofitamab

Intravenous infusion

DRUG: Obinutuzumab

Intravenous infusion
Participant Group/Arm

EXPERIMENTAL: Phase 2

Participants will be randomized to 1 of 2 different dose levels of PF-07901801 which will be administered in combination with fixed doses of glofitamab after a dose of obinutuzumab. Approximately 50 participants will be enrolled (25 per dose).

Intervention/Treatment

DRUG: maplirpacept (PF-07901801)

Intravenous infusion

DRUG: Glofitamab

Intravenous infusion

DRUG: Obinutuzumab

Intravenous infusion
Study design table for Clinical Trial

Key eligibility criteria

Inclusion criteria
Key
  • Histologically confirmed diagnosis of DLBCL
  • Relapsed or refractory disease
  • Participant is not be a candidate for or is unwilling to undergo high dose chemotherapy and subsequent stem cell transplant and/or is unable to receive chimeric antigen receptor (CAR) T-cell therapy
  • Previous treatment with at least two prior lines of systemic therapy (for phase 2, at least 2 and no more than 4 prior lines of systemic therapy). Prior therapy must include an anti-CD20 antibody.
  • Adequate bone marrow, hepatic and renal function
  • Eastern Cooperative Oncology Group (ECOG) ≤2
Key Exclusion Criteria:
  • Prior treatment with anti-CD47 and/or prior glofitamab or anti-CD20 x CD3 containing regimen. Refractoriness to an obinutuzumab monotherapy containing regimen.
  • Prior allogeneic stem cell transplantation or autologous stem cell transplantation within 12 weeks prior to enrolment
  • High Grade B-Cell Lymphoma
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection.
Exclusion criteria
  • Prior treatment with anti-CD47 and/or prior glofitamab or anti-CD20 x CD3 containing regimen. Refractoriness to an obinutuzumab monotherapy containing regimen.
  • Prior allogeneic stem cell transplantation or autologous stem cell transplantation within 12 weeks prior to enrolment
  • High Grade B-Cell Lymphoma
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection.

Key dates

Study start date
  • August 2023
Estimated primary completion date
  • October 2028

Key endpoints

Primary Outcome Measures
Outcome Measure

Phase 1b: Number of participants with Dose limiting toxicities (DLT)

Measure Description

DLTs are a predefined set of adverse events that are at least possibly related to any or all of the investigational agents.

Time Frame

21 days following first PF-07901801 dose

Outcome Measure

Phase 2: Objective Response (OR)

Measure Description

OR defined as proportion of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Lugano Response Classification Criteria 2014.

Time Frame

Time from the date of first dose of study intervention until the first documentation of disease progression, death, or start of new anticancer therapy (assessed up to approximately 24 months)

Primary Outcome Measures table for Clinical Trial
Secondary Outcome Measures:
Outcome Measure

Phase 1b and Phase 2: Frequency of adverse events (AE)

Measure Description

Type and severity (severity according to the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version 5.0). Severity of Cytokine Release Syndrome (CRS) and Immune effector cell-associated neurotoxicity syndrome (ICANS) assessed according to ASTCT criteria.

Time Frame

Time from the date of first dose of study intervention through 28 days after last dose of PF-07901801 or 90 days after last dose of glofitamab or obinutuzumab (assessed up to approximately 24 months)

Outcome Measure

Phase 1b and Phase 2: Frequency of clinical laboratory abnormalities

Measure Description

Type and severity (severity according to the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version 5.0).

Time Frame

Time from the date of first dose of study intervention through 28 days after last dose of PF-07901801 or 90 days after last dose of glofitamab or obinutuzumab (assessed up to approximately 24 months)

Outcome Measure

Phase 1b: Objective Response (OR)

Measure Description

OR defined as proportion of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Lugano Response Classification Criteria 2014.

Time Frame

Time from the date of first dose of study intervention until the first documentation of disease progression, death, or start of new anticancer therapy (assessed up to approximately 24 months)

Outcome Measure

Phase 1b and Phase 2: Duration of Response (DoR)

Measure Description

DoR defined as the time from the first documentation of OR until progressive disease (PD), or death due to any cause, whichever occurs first.

Time Frame

Time from the date of first dose of study intervention until the first documentation of disease progression, death, or start of new anticancer therapy (assessed up to approximately 24 months)

Outcome Measure

Phase 1b and Phase 2: Complete Response (CR)

Measure Description

CR defined per Lugano Response Classification Criteria 2014

Time Frame

Time from the date of first dose of study intervention until the first documentation of disease progression, death, or start of new anticancer therapy (assessed up to approximately 24 months)

Outcome Measure

Phase 1b and Phase 2: Duration of Complete Response (DoCR)

Measure Description

DoCR defined as the time from the first documentation of a CR until PD, or death due to any cause, whichever occurs first.

Time Frame

Time from the date of first dose of study intervention until PD, or death due to any cause, whichever occurs first (assessed up to approximately 24 months)

Outcome Measure

Phase 1b and Phase 2: Progression Free Survival (PFS)

Measure Description

PFS is defined as the time from the date of first dose until PD per Lugano Response Classification Criteria 2014, or death due to any cause, whichever occurs first.

Time Frame

Time from the date of first dose of study intervention until PD, or death due to any cause, whichever occurs first (assessed up to approximately 24 months)

Outcome Measure

Phase 1b and Phase 2: Serum Concentration Versus Time Summary of PF-07901801

Measure Description

Pre- and post-dose concentrations of PF-07901801

Time Frame

Pre and post-infusion on Day 1 of Cycle 1 and 2 (each cycle is 21 days), Pre-infusion on Day 8 of Cycle 1, Pre-infusion on Day 1 of Cycles 3, 4, 5, 7, 10, 13 and every 6 cycle thereafter until end of treatment (approximately 24 months)

Outcome Measure

Phase 1b and Phase 2: Serum Concentration Versus Time Summary of glofitamab

Measure Description

pre- and post-dose concentrations of glofitamab

Time Frame

Pre-infusion on Days 8 and 15 of Cycle 0 (cycle duration is 21 days), Pre-infusion, post-Infusion on Day 1 of Cycle 1 and 2, Pre-infusion on Day 1 of Cycle 3, 4, 7, 10 and 12.

Outcome Measure

Phase 1b and Phase 2: Number of participants with Anti-Drug Antibody (ADA) against PF-07901801

Measure Description

To evaluate immunogenicity of PF-07901801

Time Frame

On the first day of every 21-day cycle through 5 cycles, then every third cycle from cycle 7 through cycle 13 and then every sixth cycle thereafter until end of PF-07901801 treatment (assessed up to approximately 24 months)

Outcome Measure

Phase 1b and Phase 2: Number of participants with Anti-Drug Antibody (ADA) against glofitamab

Measure Description

To evaluate immunogenicity of glofitamab

Time Frame

On the 8th day of cycle 0 (cycle duration is 21 days), then the first day of every 21-day cycle through cycle 4, then the first day of cycle 7, 10 and 12 (last assessment).

Outcome Measure

Phase 1b and Phase 2: Number of participants with Neutralizing antibody (NAb) for PF-07901801

Measure Description

To evaluate immunogenicity of PF-07901801

Time Frame

On the first day of every 21-day cycle through 5 cycles, then every third cycle from cycle 7 through cycle 13 and then every sixth cycle thereafter until end of PF-07901801 treatment (assessed up to approximately 24 months)

Secondary Outcome Measures table for Clinical Trial

Number of participants

70

Collaborators and investigators

Sponsor: Pfizer

Collaborator: Hoffmann-La Roche

This information is current as of August 16th 2024.
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More Information Close NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier. NCT05896163