New combo therapy offers hope for Tough-to-Treat lymphoma
NCT ID NCT07460362
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a combination of two drugs, glofitamab and lenalidomide, in people with a fast-growing type of lymphoma (mantle cell lymphoma) that has come back or not responded to treatment, especially after a BTK inhibitor stopped working. About 43 adults will receive the drugs intravenously and by mouth. The goal is to see how many patients achieve a significant reduction or disappearance of cancer after treatment.
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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 43 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Dec 2029
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 to 80 years
- 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 Forms * Age: \>= 18 to 80 years * Eastern Cooperative Oncology Group =\< 2 * Diagnosis of MCL established by histologic assessment * Previously treated with at least one prior line of systemic therapy for mantle cell lymphoma. * Prior therapy have included a BTK inhibitor, including ibrutinib, zanubrutinib, obrutinib, acalabrutinib and various BTKi in clinical trials. BTki exposure is required, which include BTKi failure or intolerance. BTKi failure is defined as progression of disease during BTKi therapy or patients have progressed or relapsed after completing BTK inhibitor therapy * At least one high risk features as classified: * Blastoid/pleomorphic variants ✔ Ki67 ≥50% ✔ TP53 mutation or deletion * Bulky disease (defined as any lesion ≥7.5 cm on the screening computed tomography \[CT\] scan) * Patients that did not achieve a CR with their first-line treatment * early disease progression (POD24) ✔ patients with relapse and refractory treatment above 3 lines * Measurable lesions on cross-sectional imaging documented by diagnostic imaging(MRI, CT or PET-CT), (GTD)≥1.5 cm * Adequate liver function : Total bilirubin =\< 3 x upper limit of normal (ULN) (unless has Gilbert's disease), Aspartate aminotransferase (AST) =\< 5.0 x ULN, Alanine aminotransferase (ALT) =\< 5.0 x ULN Exclusion Criteria: * • Already enrolled in other Ongoing interventional or non-interventional R/R MCL clinical trials; * Currently receiving immunosuppressive treatment for other diseases; * Previous treatment with lenalidomide; * Combined with other malignant tumors within 3 years; * The researcher determines that they are not suitable to participate in this study; * Serious mental or neurological disorders that affect informed consent and/or the expression or observation of adverse reactions; * Have a history of major or extensive cardiovascular disease, such as New York Heart Association class III or Grade IV heart disease or objective assessment, myocardial infarction, unstable arrhythmia or unstable angina within 6 months before the first cycle; * Recent major surgery (within 4 weeks before the start of the first cycle); * Active autoimmune diseases with poor treatment control; * Any active infection that may affect the safety of the participant, including bacterial, fungal and various viral infections, occurred within 7 days before the first day of cycle 1; * Positive SARS-CoV-2 PCR test within 7 days prior to enrollment * Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \[HBsAg\] serology) Participants with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) DNA is undetectable at the time of screening. Such participants must be willing to undergo HBV DNA testing on Day 1 of every cycle and every 3 months for at least 12 months after the final cycle of study treatment and appropriate antiviral therapy as indicated. * Positive test results for hepatitis C (hepatitis C virus \[HCV\] antibody serology testing) Participants positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA. * A history of severe deep vein thrombosis event or pulmonary embolism within 6 months * Patient follow-up was not possible.
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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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Peking University Third Hospital
RECRUITINGBeijing, Beijing Municipality, 100191, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Two-Drug combo outsmart a tough blood cancer?
- New combo tackles tough lymphoma after other treatments fail
- New hope for aggressive lymphoma: drug cocktail aims to control High-Risk MCL
- New CAR-T therapy targets BAFF-R to fight resistant lymphoma
- New hope for tough lymphoma: experimental drug ICP-248 targets relapsed mantle cell cancer
- New antibody drug shows promise for Hard-to-Treat lymphoma