Tafasitamab and Lenalidomide as First Salvage Therapy for Residual Large B Cell Lym

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

The purpose of the study is to evaluate the safety and efficacy of tafasitamab and lenalidomide in participants with Large B Cell Lymphoma (LBCL) after axicabtagene ciloleucel (axi-cel) treatment. Participants will be asked to spend about 12 months in this study.

Study Overview

• Status: Recruiting
• Conditions: Large B-cell Lymphoma
• Intervention / Treatment: Drug: Tafasitamab; Drug: Lenalidomide

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Kim Sprenger; Phone Number: 813-745-0330; Email: ICETtrials@moffitt.org

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Recruiting
      • Moffitt Cancer Center
      • Sub-Investigator: Sameh Gaballa, MD
      • Sub-Investigator: Taiga Nishihori, MD
      • Sub-Investigator: Michael Jain, MD, PhD
      • Sub-Investigator: Farhad Khimani, MD
      • Principal Investigator: Frederick Locke, MD
      • Sub-Investigator: Julio Chavez, MD
      • Sub-Investigator: Aleksandr Lazaryan, MD, PhD
      • Sub-Investigator: Sayeef Mirza, MD
      • Sub-Investigator: Bijal Shah, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tafasitamab and Lenalidomide Treatment; Participants will receive the study drug, Tafasitamab, intravenously on a weekly basis for the first three 28-day cycles (Cycles 1-3) and then every 2 weeks starting at Cycle 4 onwards. Participants will take the study drug, Lenalidomide, once daily for 21 days out of each 28-day cycle for 6 cycles.	Drug: Tafasitamab; The recommended dose of tafasitamab is 12 mg/kg.; Drug: Lenalidomide; The starting dose for lenalidomide will be 25 mg PO daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Response Rate (CRR)	Complete Response Rate (CRR) is defined as the proportion of patients with a Complete Response (CR)	Up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objectives Response Rate (ORR)	Defined as the incidence of either a complete response (CR) or a partial response (PR) per Lugano Classification as determined by study investigators.	Up to 12 months
Duration of Response (DoR)	DoR is defined as the date of their first objective response to disease progression per Lugano Classification as determined by study investigators or death from any cause.	Up to 12 months
Progression Free Survival (PFS)	Defined as the time from tafasitamab infusion date to the date of disease progression per Lugano Classification as determined by study investigators or death from any cause.	Up to 12 months

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: Incyte Corporation
• Investigators: Principal Investigator: Frederick Locke, MD, Moffitt Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: December 30, 2024
• First Submitted That Met QC Criteria: December 30, 2024
• First Posted (Actual): January 6, 2025

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carboxylic Acids; Piperidines; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Piperidones; Isoindoles; Lenalidomide; tafasitamab
• Other Study ID Numbers: MCC-21955

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No