Clinical Trial 21955

• Overview

  Study Title:

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

  Objective:

  Primary Objective: To determine complete response rate (CRR) to tafa+len for patients with residual disease (PR or SD) on day +28 after axi-cel administration. Secondary Objectives: Characterize and evaluate the safety profile of combination of tafa+len administered after axi-cel based on CTCAE v5.0 criteria. Determine event free survival (EFS) to Tafa+len as first salvage therapy after axi-cel administration. To determine progression-free survival (PFS). To determine overall survival (OS). To determine objective response rate (ORR). To determine duration of response (DoR). Exploratory Analysis: To evaluate the ability of ctDNA-based MRD status to predict time to event outcomes in patients treated with tafa+len. To evaluate whether CD19 expression is associated with response to tafa+len. To determine if tafa+len re-expands CAR T cells as detected in the blood using qt PCR. Evaluate immune reconstitution following tafa+len.

• Treatments

  Therapies:

  Cell Therapy; Immunomodulators

  Medications:

  CC-5013 (Lenalidomide); Lenalidomide (Revlimid); Tafasitamab ()

• Inclusion Criteria

  Key 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. (Cheson et al. J Clin Oncol 2014)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Participants must have adequate organ and bone marrow function as defined below: Absolute Neutrophil Count (ANC) ≥1 × 10⁹/L, Platelet Count ≥50 × 10⁹/L (unless either was secondary to bone marrow involvement by diffuse large B-cell lymphoma as shown by recent bone marrow aspiration and bone marrow biopsy).
  • Patients must have adequate hepatic function defined as: total serum bilirubin concentration of less than 2.5 times the upper limit of normal (ULN) unless secondary to Gilbert’s syndrome or documented liver involvement by lymphoma (patients with Gilbert’s syndrome or documented liver involvement by lymphoma could be included if their total bilirubin concentration was up to 5 times ULN); alanine transaminase, aspartate aminotransferase and alkaline phosphatase concentrations of up to 3 times ULN or less than 5 times ULN in patients with documented liver involvement.
  • Patients must have adequate renal function defined as: Serum creatinine clearance of ≥60mL/min either measured or calculated using a standard Cockcroft and Gault formula.
  • 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.
  • Other inclusion criteria may apply.

• Exclusion Criteria

  Key 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.
  • Other exclusion criteria may apply.

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