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 STUDY OF PF-07901801, A CD47 BLOCKING AGENT, WITH TAFASITAMAB AND LENALIDOMIDE FOR PARTICIPANTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B CELL LYMPHOMA NOT ELIGIBLE FOR STEM CELL TRANSPLANTATION
Phase 1 /2
NCT05626322

Active Not-enrolling

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Locations

United States, Japan, Korea, Republic of, Puerto Rico

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Study design

Participant Group/Arm

EXPERIMENTAL: Phase 1b

Participants will be allocated to sequential dose levels of maplirpacept (PF-07901801), administered in combination with standard doses of tafasitamab and lenalidomide, to select two doses for further evaluation in Phase 2. Approximately 20 participants will be enrolled.

Intervention/Treatment

DRUG: Maplirpacept

Intravenous infusion

DRUG: Tafasitamab

Intravenous infusion

DRUG: Lenalidomide

Oral (by mouth)

Participant Group/Arm

EXPERIMENTAL: Phase 2

Participants will be randomized to 1 of 2 different dose levels of maplirpacept (PF-07901801) which will be administered in combination with standard doses of tafasitamab and lenalidomide. Approximately 50 participants will be enrolled (25 per dose).

Intervention/Treatment

DRUG: Maplirpacept

Intravenous infusion

DRUG: Tafasitamab

Intravenous infusion

DRUG: Lenalidomide

Oral (by mouth)

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 one prior line of systemic therapy (for phase 2, at least 1 and no more than 2 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
  • Must provide a tumor tissue sample (fresh or archival, collected prior to start of treatment) for biomarker analysis

Key Exclusion Criteria:

  • Prior treatment with an anti-CD47 or anti-CD19 (other than CAR T) or immunomodulatory agents
  • Prior allogeneic stem cell transplantation or autologous stem cell transplantation within 12 weeks prior to enrolment
  • Participants with active, uncontrolled bacterial, fungal or viral infection.
Exclusion criteria

Key Exclusion Criteria:

  • Prior treatment with an anti-CD47 or anti-CD19 (other than CAR T) or immunomodulatory agents
  • Prior allogeneic stem cell transplantation or autologous stem cell transplantation within 12 weeks prior to enrolment
  • Participants with active, uncontrolled bacterial, fungal or viral infection.

Key dates

Study start date
  • August 2023
Estimated primary completion date
  • May 2025

Key endpoints

Primary Outcome Measures
Outcome Measure

Phase 1b: Dose limiting toxicity (DLT) rate

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

28 days following first dose

Outcome Measure

Phase 2: Objective Response Rate (ORR)

Measure Description

OR defined as complete response or partial response as 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)

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).

Time Frame

Time from the date of first dose of study intervention through 28 days after last dose of study intervention (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 study intervention (assessed up to approximately 24 months)

Outcome Measure

Phase 1b: Objective Response Rate (ORR)

Measure Description

OR defined as complete response or partial response 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 Response (DoR)

Measure Description

CR and PR defined per Lugano Response Classification Criteria 2014

Time Frame

Time from the first documentation of objective response until disease progression or death due to any cause, whichever occurs first (assessed up to approximately 24 months)

Outcome Measure

Phase 1b and Phase 2: Complete Response Rate (CRR)

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

CR defined per Lugano Response Classification Criteria 2014

Time Frame

Time from the first documentation of a CR 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

Progression defined per Lugano Response Classification Criteria 2014

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: Pharmacokinetic parameters of PF-07901801

Measure Description

Pre- and post-dose concentrations of PF-07901801

Time Frame

On the first and 8th day of the first 28-day cycle, then the first day of every cycle through 6 cycles, then every third cycle through 13 cycles and every sixth cycle thereafter until end of treatment (assessed up to approximately 24 months)

Outcome Measure

Phase 1b and Phase 2: Pharmacokinetic parameters of tafasitamab

Measure Description

Pre-dose concentrations of tafasitamab

Time Frame

On the first day of every 28-day cycle through 6 cycles, then every third cycle through 13 cycles and every sixth cycle thereafter until end of treatment (assessed up to approximately 24 months)

Outcome Measure

Phase 1b and Phase 2: Pharmacokinetic parameters of of lenalidomide

Measure Description

Pre-dose concentrations of lenalidomide.

Time Frame

On the first first day of the first four 28-day cycles.

Outcome Measure

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

Measure Description

To evaluate immunogenicity of PF-07901801

Time Frame

On the first day of every 28-day cycle through 6 cycles, then every third cycle through 13 cycles and every sixth cycle thereafter until end of treatment (assessed up to approximately 24 months)

Outcome Measure

Phase 1b and Phase 2: Incidence of Anti-Drug Antibody (ADA) against tafasitamab

Measure Description

To evaluate immunogenicity of tafasitamab

Time Frame

On the first day of every 28-day cycle through 6 cycles, then every third cycle through 13 cycles and every sixth cycle thereafter until end of treatment (assessed up to approximately 24 months)

Outcome Measure

Phase 1b and Phase 2: Neutralizing antibody (NAb) titers for PF-07901801

Measure Description

To evaluate immunogenicity of PF-07901801

Time Frame

On the first day of every 28-day cycle through 6 cycles, then every third cycle through 13 cycles and every sixth cycle thereafter until end of treatment (assessed up to approximately 24 months)

Outcome Measure

Phase 1b and Phase 2: Neutralizing antibody (NAb) titers for tafasitamab

Measure Description

To evaluate immunogenicity of tafasitamab

Time Frame

On the first day of every 28-day cycle through 6 cycles, then every third cycle through 13 cycles and every sixth cycle thereafter until end of treatment (assessed up to approximately 24 months)

Secondary Outcome Measures table for Clinical Trial

Number of participants

4

Collaborators and investigators

Sponsor: Pfizer

Collaborator: MorphoSys AG, Incyte Corporation

This information is current as of September 5th 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. NCT05626322