Effects of two medicines on relapsed or refractory diffuse large B-cell lymphoma
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
PHASE1; PHASE2 · Pfizer · NCT05896163
This study is testing if a combination of two new medicines can help adults with relapsed or refractory diffuse large B-cell lymphoma feel better after they’ve already tried other treatments.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pfizer (industry) |
| Drugs / interventions | glofitamab, obinutuzumab, chimeric antigen receptor, chemotherapy, CAR-T |
| Locations | 25 sites (Fairway, Kansas and 24 other locations) |
| Trial ID | NCT05896163 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of two investigational drugs, maplirpacept and glofitamab, given together after a single dose of obinutuzumab in adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Participants must have a confirmed diagnosis of DLBCL and have received at least two prior treatments. The study is divided into two phases: Phase 1b focuses on determining the appropriate dosage, while Phase 2 assesses the safety and efficacy of the treatment combination. The goal is to find a recommended dose for future studies.
Who should consider this trial
Good fit: Ideal candidates are adults with relapsed or refractory DLBCL who have received at least two prior treatments and are not candidates for stem cell transplant or CAR-T therapy.
Not a fit: Patients who have previously received anti-CD47 treatments or have high-grade B-cell lymphoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new option for patients with difficult-to-treat DLBCL.
How similar studies have performed: Other studies have shown promise with similar approaches, but this specific combination is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * 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.
Where this trial is running
Fairway, Kansas and 24 other locations
- The University of Kansas Cancer Center ,Investigational Drug Services — Fairway, Kansas, United States (RECRUITING)
- The University of Kansas Clinical Research Center — Fairway, Kansas, United States (RECRUITING)
- The University of Kansas Hospital — Kansas City, Kansas, United States (RECRUITING)
- University of Kansas Hospital Cambridge North Tower A — Kansas City, Kansas, United States (RECRUITING)
- Allina Health Cancer Institute - Abbott Northwestern Hospital — Minneapolis, Minnesota, United States (NOT_YET_RECRUITING)
- Siteman Cancer Center — Saint Louis, Missouri, United States (RECRUITING)
- Barnes-Jewish Hospital Parkview Tower — Saint Louis, Missouri, United States (RECRUITING)
- Barnes-Jewish Hospital — Saint Louis, Missouri, United States (RECRUITING)
- Washington University School of Medicine — Saint Louis, Missouri, United States (RECRUITING)
- Swedish Cancer Institute — Seattle, Washington, United States (RECRUITING)
- Swedish Medical Center — Seattle, Washington, United States (RECRUITING)
- Princess Alexandra Hospital — Brisbane, Queensland, Australia (NOT_YET_RECRUITING)
- St Vincent's Hospital Melbourne — Fitzroy, Victoria, Australia (NOT_YET_RECRUITING)
- Epworth Freemasons — Melbourne, Victoria, Australia (NOT_YET_RECRUITING)
- Slade Pharmacy — Richmond, Victoria, Australia (NOT_YET_RECRUITING)
- Sheba Medical Center — Ramat Gan, Hamerkaz, Israel (RECRUITING)
- Rambam Health Care Campus — Haifa, Hatsafon, Israel (RECRUITING)
- Sourasky Medical Center — Tel Aviv, Tell Abīb, Israel (NOT_YET_RECRUITING)
- Hadassah Medical Center — Jerusalem, Yerushalayim, Israel (RECRUITING)
- Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital — Nagoya, Aichi, Japan (RECRUITING)
- Shizuoka Cancer Center — Nagaizumi-cho, Shizuoka, Japan (RECRUITING)
- National Hospital Organization Kyushu Cancer Center — Fukuoka, Japan (RECRUITING)
- China Medical University Hospital — Taichung, Taiwan (NOT_YET_RECRUITING)
- National Taiwan University Hospital — Taipei, Taiwan (RECRUITING)
- Koo Foundation Sun Yat-Sen Cancer Center — Taipei, Taiwan (RECRUITING)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diffuse Large B-Cell Lymphoma, DLBCL, Lymphoma, Relapsed, Refractory, CD20, CD3, CD47