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Diffuse Large B-Cell LymphomaPhase 1/2MAPtivate-6NCT05896163

A Study to Learn About the Effects of Two Study Medicines (Maplirpacept [PF-07901801] And Glofitamab) When Given Together In People With Relapsed Or Refractory Diffuse Large B Cell Lymphoma.

A Phase 1/2 study testing maplirpacept (PF-07901801), Glofitamab and Obinutuzumab in people with Diffuse Large B-Cell Lymphoma, run by Pfizer at 10 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to learn about the effects of two study medicines (maplirpacept [PF-07901801] and glofitamab) when given together for the treatment of diffuse large B-cell lymphoma (DLBCL) that is relapsed or is refractory. Relapsed means has returned after last treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diffuse Large B-Cell Lymphoma
What is being tested?
maplirpacept (PF-07901801), Glofitamab and Obinutuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
10 sitesin 4 countries
Study dates
30 Aug 2023to 9 Apr 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

10 sites in 4 countries.

10 sites in 4 countries

United States4 sites

  • University of Kansas Hospital Cambridge North Tower A

    Kansas City, Kansas, 66160

  • Siteman Cancer Center

    St Louis, Missouri, 63108

  • Barnes-Jewish Hospital Parkview Tower

    St Louis, Missouri, 63110

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

Israel3 sites

  • Rambam Health Care Campus

    Haifa, Northern District, 3109601

  • Sheba Medical Center

    Ramat Gan, Central District, 5262100

  • Sourasky Medical Center

    Tel Aviv, TELL ABĪB, 6423906

Other trials in Israel

Japan2 sites

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395

  • Shizuoka Cancer Center

    Nagaizumi-cho, Shizuoka, 411-8777

Other trials in Japan

Turkey (Türkiye)1 site

  • Gazi University I lcalth Research and Annlica1ion Cenlcr Gazi Hospilal

    Ankara, 06560

Other trials in Turkey (Türkiye)

About this study

Official title: 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

The purpose of this study is to learn about the effects of two study medicines (maplirpacept [PF-07901801] and glofitamab) when given together for the treatment of diffuse large B-cell lymphoma (DLBCL) that is relapsed or is refractory. Relapsed means has returned after last treatment. Refractory means that it has not responded to last treatment. The two study medicines are given after a single dose of obinutuzumab which is the third study medicine.

DLBCL is a type of non-Hodgkin lymphoma (NHL). NHL is a cancer of the lymphatic system. It develops when the body makes abnormal B lymphocytes. These lymphocytes are a type of white blood cell that normally help to fight infections.

Read more

This study is seeking adult participants who:

  • Have histologically confirmed diagnosis of DLBCL
  • Have received at least two first lines of treatment for NHL.
  • Are unable or unwilling to undergo a stem cell transplant or CAR-T cell therapy.

Stem cell transplant is a procedure in which a patient receives healthy blood-forming cells to replace their own stem cells that have been destroyed by treatment.

A CAR-T therapy is a type of treatment in which a patient's T cells are changed in the laboratory so they will attack cancer cells.

Everyone in this study will receive all three medicines at the study site by intravenous (IV) infusion which is given directly into a vein. The two study medicines (maplirpacept [PF-07901801] and glofitamab) will be given in 21-day cycles.

At Cycle 0, participants will receive a single dose of obinutuzumab pre-treatment followed by two step-up doses of glofitamab. The combination of maplirpacept (PF-07901801) with glofitamab full dose will be administered for the first time at Cycle 1 Day 1.

Maplirpacept (PF-07901801) will be given weekly for the first three cycles and then every three weeks. Glofitamab will be given every 3 weeks for approximately 9 months. Thereafter participants will continue to receive maplirpacept alone.

Maplirpacept (PF-07901801) will be given at different doses to different participants. Everyone taking part will receive the same fixed doses of glofitamab and obinutuzumab studied in patients with DLBCL.

The study will compare the experiences of people receiving different doses of maplirpacept (PF-07901801). This will help to determine what dose is safe and effective when given with the other 2 study medicines.

Read the detailed description

This is a multicenter, open-label, Phase 1b/2 study to evaluate the safety, tolerability and potential clinical benefits of maplirpacept PF-07901801, an anti-CD47 molecule, in combination with fixed doses of glofitamab after a single dose of obinutuzumab in participants with relapsed/refractory (R/R) DLBCL not eligible for or unwilling to undergo high dose chemotherapy and subsequent autologous stem cell transplantation (ASCT) or unable to receive approved chimeric antigen receptor T-cell (CAR-T) therapy (for example, due to logistical limitations).

For Phase 1b, participants must have previously received at least 2 prior systemic treatment regimen. For Phase 2, participants must have received at least 2 but no more than 4 prior systemic treatment regimens. All participants must have previously received an anti-CD20 containing regimen.

Phase 1b will assess dose-limiting toxicities of PF-07901801 when administered in combination with glofitamab, to select doses for the Phase 2 part of the study. Phase 2 will evaluate safety and efficacy to determine the recommended Phase 3 dose of PF-07901801 to be administered in combination with glofitamab.

Being tested
maplirpacept (PF-07901801), Glofitamab, Obinutuzumab
Keywords
DLBCL, Lymphoma, Relapsed, Refractory, CD20, CD3, CD47, Glofitamab, Obinutuzumab, Maplirpacept
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Lymphoma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • maplirpacept (PF-07901801)Drug

    Intravenous infusion

  • GlofitamabDrug

    Also called Columvi

    Intravenous infusion

  • ObinutuzumabDrug

    Also called Gazyva

    Intravenous infusion

Study groups in NCT05896163
Study groupRoleWhat they receive
Phase 1bExperimentalParticipants 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 doses of PF-07901801 for further evaluation in Phase 2. Approximately 20 participants will be enrolled.
Receives: Drug: maplirpacept (PF-07901801); Drug: Glofitamab; Drug: Obinutuzumab
Phase 2ExperimentalParticipants will be randomized to 1 of 3 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.
Receives: Drug: maplirpacept (PF-07901801); Drug: Glofitamab; Drug: Obinutuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 21 days following first PF-07901801 dose

  2. Phase 2: Objective Response (OR)

    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.

    Measured: 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)

Secondary outcomes (10)

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

    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.

    Measured: 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)

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

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

    Measured: 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)

  3. Phase 1b: Objective Response (OR)

    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.

    Measured: 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)

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

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

    Measured: 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)

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

    CR defined per Lugano Response Classification Criteria 2014

    Measured: 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)

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

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

    Measured: 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)

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

    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.

    Measured: 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)

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

    Pre- and post-dose concentrations of PF-07901801

    Measured: 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)

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

    To evaluate immunogenicity of PF-07901801

    Measured: 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)

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

    To evaluate immunogenicity of PF-07901801

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2023
  2. Study start30 Aug 2023
  3. Primary completion9 Apr 2026
  4. Study completion9 Apr 2026

Why it stopped: Business/Administrative decision to pursue other programs/assets within the oncology portfolio. Not due to any detected safety signals or requests from regulatory authorities.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Open label/randomized
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05896163
Sponsor's protocol ID
C4971006
Other IDs
2022-502822-41-00
Acronym
MAPtivate-6
Status last verified
May 2026
First submitted
10 May 2023
Last updated
6 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing maplirpacept (PF-07901801), Glofitamab and Obinutuzumab in people with Diffuse Large B-Cell Lymphoma, run by Pfizer at 10 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States, Israel, Japan, Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Business/Administrative decision to pursue other programs/assets within the oncology portfolio. Not due to any detected safety signals or requests from regulatory authorities.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1b: Number of participants with Dose limiting toxicities (DLT) (time frame: 21 days following first PF-07901801 dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05896163.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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