Recruiting

Phase 2

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

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Code:

NCT06760156

Conditions

Large B-cell Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tafasitamab

Lenalidomide

Study Details

Brief summary:

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.

Conditions

Large B-cell Lymphoma

Study ID

NCT06760156

Start date

Mar 19, 2025

Status verified date

Mar, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

28 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Tafasitamab

The recommended dose of tafasitamab is 12 mg/kg.

Lenalidomide

The starting dose for lenalidomide will be 25 mg PO daily.

Primary outcome measure

Complete Response Rate (CRR) [ Time Frame: Up to 3 months ]

Central Contacts and Locations

Central contacts

Kim Sprenger

813-745-0330 ICETtrials@moffitt.org

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Principal Investigator:

Frederick Locke, MD

More Information

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Last update posted

Apr 3, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute on 2026-04-03.