Using Tafasitamab and Lenalidomide for Large B-cell Lymphoma after CAR-T Therapy

Phase 2 Study of Tafasitamab and Lenalidomide as First Salvage Therapy for Residual Large B Cell Lymphoma After Axicabtagene Ciloleucel

This study is testing if the combination of tafasitamab and lenalidomide can help people with Large B-cell Lymphoma who still have cancer after CAR-T therapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute (Academic / other)
• Drugs / interventions: tafasitamab, CAR-T, CAR T
• Locations: 1 site (Tampa, Florida)
• Trial ID: NCT06760156 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of tafasitamab and lenalidomide as first salvage therapy in patients with Large B-cell Lymphoma (LBCL) who have residual disease following treatment with axicabtagene ciloleucel (axi-cel). Participants will undergo treatment for approximately 12 months, with assessments to monitor their response to the therapy. The study aims to provide insights into the effectiveness of these medications in managing LBCL after CAR-T therapy.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a documented history of Large B-cell Lymphoma and measurable disease after CAR-T treatment.

Not a fit: Patients who do not have measurable disease or those with a poor ECOG performance status may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for patients with residual Large B-cell Lymphoma after CAR-T therapy.

How similar studies have performed: Other studies have explored similar combinations in hematologic malignancies, showing promising results, but this specific approach is novel.

Eligibility criteria

Inclusion Criteria:

* Patients must have histologically documented history of large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
* Adult males or females must be of age ≥18 years or older at time of signing informed consent.
* Patients must be capable of understanding the protocol with willingness to comply with all study procedures including availability for the duration of the study.
* Patients must be able to understand and willing to sign a written informed consent form (ICF) document.
* Measurable PET/CT positive disease (partial response or stable disease per the 2014 Lugano Classification) on PET/CT obtained at least 21 days after, but no more than 60 days after CAR-T with axicabtagene-ciloleucel.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Participants must have adequate organ and bone marrow function.
* Patients must have adequate hepatic function.
* Patients must have adequate renal function.
* Baseline Oxygen Saturation \>92% on room air.
* Females of reproductive potential must avoid pregnancy for at least 4 weeks before beginning lenalidomide therapy, during therapy, during dose interruptions and for at least 4 weeks after completing therapy. Females must commit either to abstain continuously from heterosexual sexual intercourse or to use two methods of reliable birth control, beginning 4 weeks prior to initiating treatment with lenalidomide, during therapy, during dose interruptions and continuing for 4 weeks following discontinuation of lenalidomide therapy.

Exclusion Criteria:

* Patients who are currently receiving or who have received any investigational study agent ≤4 weeks prior to the screening visit are ineligible.
* Detectable cerebrospinal fluid malignant cells, brain metastases, or active central nervous system (CNS) lymphoma after CAR T cell administration.
* History or presence of CNS disorder, such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
* Presence of bacterial, viral, fungal, and/or other infection of any origin that is uncontrolled and/or requires intravenous (IV) antimicrobials for treatment.
* Known cardiac atrial or cardiac ventricular lymphoma involvement.
* History of symptomatic pulmonary embolism within 6 months of enrollment.
* Known primary immunodeficiency.
* History of autoimmune disease (e.g. Crohn's disease, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years.
* History of hypersensitivity, allergy or severe skin reactions to lenalidomide (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis).
* History of hypersensitivity, allergy or previous exposure to tafasitamab.
* Any medical condition deemed by the treating physician likely to interfere with assessment of safety or efficacy of study treatment.

Where this trial is running

Tampa, Florida

• Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Frederick Locke, MD — Moffitt Cancer Center
• Study coordinator: Kim Sprenger

Conditions Large B-cell Lymphoma