Promising cocktail targets deadly lymphoma mutation
NCT ID NCT07240194
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests a combination of three drugs—glofitamab, a PD-1 inhibitor, and lenalidomide—in 24 adults with relapsed or refractory large B-cell lymphoma that has a TP53 gene mutation. The goal is to see if this mix can shrink tumors or make them disappear. The study is currently recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- glofitamab, PD-1 inhibitor, and lenalidomide
- What this could lead to
- If this works, it could offer a new treatment option for people with a hard-to-treat form of lymphoma that has not responded to standard therapies.
- What could go wrong
- This is a small, early-phase trial with only 24 participants, so results may not apply to everyone. The combination may cause side effects like cytokine release syndrome, and it is not yet known if it will improve survival.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Signed informed consent form before any study-specific procedures. * Age ≥ 18 years at the time of consent. * Histologically confirmed large B-cell lymphoma (LBCL) with CD20 expression, including but not limited to:Diffuse large B-cell lymphoma not otherwise specified (DLBCL-NOS),Transformed follicular lymphoma (tFL),Grade 3B follicular lymphoma (3B FL),High-grade B-cell lymphoma (HGBCL),Intravascular large B-cell lymphoma (IVLBCL),Primary mediastinal large B-cell lymphoma (PMBCL),Epstein-Barr virus-positive LBCL (EBV+ LBCL). * Relapsed or refractory (R/R) LBCL defined as: Relapsed: Disease recurrence after achieving remission for longer than 6 months after completing the last line of therapy. Refractory: Failure to achieve remission or progression within 6 months after completing the last line of therapy. * Confirmed TP53 deletion or mutation via FISH or NGS. * Not eligible for autologous stem cell transplantation (ASCT) per any of the following criteria: Age ≥ 70 years, End-stage organ dysfunction, ECOG performance status of ≥ 2,Patient decision to decline ASCT, Other investigator-determined comorbidities (e.g., severe heart or lung disease, active infections) per local clinical practice standards. * Measurable disease at baseline, with at least: One lymph node lesion ≥ 1.5 cm (in the longest diameter), or One extranodal lesion ≥ 1.0 cm (in the longest diameter). * ECOG performance status of 0, 1, or 2. * Life expectancy of ≥ 12 weeks, as assessed by the investigator. * Adequate hematologic function unless due to extensive bone marrow involvement or spleen-related complications caused by lymphoma, defined as: Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L,Platelets ≥ 50 × 10⁹/L,Hemoglobin ≥ 80 g/L. -Willingness to adhere to the study procedures, including contraception requirements during the trial for participants of reproductive potential. Exclusion Criteria: * Prior allogeneic stem cell transplantation or organ transplantation. Active central nervous system involvement by lymphoma. Active autoimmune diseases requiring immune suppressive therapy. Uncontrolled systemic infections, including active hepatitis B, hepatitis C, or HIV infection. Previous treatment with Glofitamab, another bispecific antibody targeting CD20 and CD3, or PD-1 inhibitors combined with Lenalidomide. History of severe hypersensitivity to monoclonal antibodies or any components of the study drugs. Concurrent participation in another investigational study. Use of systemic immunosuppressive therapy within 14 days prior to enrollment (excluding corticosteroids for lymphoma treatment or prevention of adverse effects). Pregnant or breastfeeding women. Any psychological, social, or medical condition that, in the investigator's opinion, could interfere with study compliance or compromise the participants' safety or outcome.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital with Nanjing Medical University
RECRUITINGNanjing, Jiangsu, 210000, China
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- Can a Two-Drug combo outsmart a deadly leukemia?
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