C4971006: A Study to Learn About the Effects of 2 Study Medicines (Maplirpacept [PF-07901801] and Glofitamab) When Given Together in People With Relapsed or Refractory Diffuse Large B Cell Lymphoma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Pfizer Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Hemic and Lymphatic Diseases [C15]

Trial duration

completed 9 Apr 2026

Decision date (initial)

2025-04-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2022-502822-41-00

ClinicalTrials.gov

NCT05896163

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Pharmacodynamic, Pharmacokinetic

Phase 1b: to assess dose limiting toxicities (DLTs), safety and tolerability of PF-07901801 and glofitamab, after a single dose of obinutuzumab in adult participants with R/R DLBCL in order to select up to 2 doses of PF-07901801 for further evaluation in Phase 2 of the study.
Phase 2: to assess the clinical anti-tumor activity of PF 07901801 in combination with glofitamab after a single dose of obinutuzumab in adult participants with R/R DLBCL.

Secondary objectives 8

1. Phase 1b: To evaluate the overall safety profile of PF 07901801 and glofitamab after a single dose of obinutuzumab
2. Phase 1b: To assess the efficacy outcomes of PF 07901801 in combination with glofitamab after a single dose of obinutuzumab
3. Phase 1b: To evaluate the pharmacokinetics (PK) of PF 07901801
4. Phase 1b: To evaluate immunogenicity of PF-07901801
5. Phase 2: To assess additional efficacy outcomes of PF 07901801 in combination with glofitamab after a single dose of obinutuzumab
6. Phase 2: To further evaluate the overall safety profile and tolerability of PF-07901801 in combination with glofitamab after a single dose of obinutuzumab
7. Phase 2: To evaluate the PK of PF-07901801
8. Phase 2: To evaluate immunogenicity of PF-07901801

Conditions and MedDRA coding

Relapsed/Refractory Diffuse Large B Cell Lymphoma

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Adults with histologically confirmed DLBCL and relapsed or refractory disease
2. Participant is not a candidate or unwilling to undergo high dose chemotherapy and subsequent autologous stem cell transplant or unable to receive approved chimeric antigen receptor T-cell therapy (CAR-T).
3. Measurable disease: at least 1 site of measurable PET-avid disease per Lugano 2014 classification.
4. Prior treatment must include at least 2 lines of systemic therapy (for Phase 2: at least 2 but no more than 4 prior lines of systemic therapy). Prior therapy must include an anti-CD20 containing regimen.
5. Adequate hematologic, hepatic and renal function.
6. Eastern Cooperative Oncology Group (ECOG) performance status ≤2.

Exclusion criteria 5

1. High-grade B-Cell lymphoma NOS or High-grade B-Cell lymphoma with MYC and BCL2 rearrangements.
2. Known or suspected primary or secondary CNS lymphoma or meningeal involvement; history of multifocal leukoencephalopathy; history of CNS disease.
3. Significant cardiac/cardiovascular/thromboembolic disease.
4. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) not resolved within 72 hours prior to study enrollment.
5. Prior treatment with anti-CD47 and/or anti-SIRPα therapy and/or prior glofitamab or anti-CD20xCD3 containing regimen.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Phase 1b: DLTs during the DLT observation period (21 days following Cycle 1 Day 1)
2. Phase 2: OR per Lugano Response Classification Criteria 2014 as assessed by the investigator.

Secondary endpoints 8

1. Phase 1b: AEs as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), timing, seriousness, and relationship to study treatment. Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), and timing. The severity of CRS and ICANS as assessed according to ASTCT criteria.
2. Phase 1b: OR, DoR, CR, DoCR, and PFS per Lugano Response Classification Criteria 2014 as assessed by the investigator.
3. Phase 1b: Pre- and post-dose concentrations of PF-07901801.
4. Phase 1b: ADAs and NAbs against PF-07901801.
5. Phase 2: DoR, CR, DoCR, and PFS by investigator in participants with measurable disease by investigator per Lugano Response Classification Criteria 2014.
6. Phase 2: AEs as characterized by type, frequency, severity (as graded by NCI CTCAE V5.0), timing, seriousness, and relationship to study treatment. Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), and timing. The Severity of CRS and ICANS will be assessed according to ASTCT criteria.
7. Phase 2: Pre- and post-dose concentrations of PF-07901801.
8. Phase 2: ADAs and NAbs against PF-07901801.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Pfizer Inc.

Sponsor organisation

Pfizer Inc.

Address

235 East 42nd Street

City

New York

Postcode

10017-5703

Country

United States

Scientific contact point

Organisation

Pfizer Inc.

Contact name

Clinical Medical Lead

Public contact point

Organisation

Pfizer Inc.

Contact name

Clinical Medical Lead

Third parties 10

Locations

3 EU/EEA countries · 18 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 19 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications