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Phase I

An Open-Label, Multicenter, Phase I Trial Evaluating the Safety and Pharmacokinetics of Escalating Doses of BTCT4465A in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia

  • Study HIC#:1509016491
  • Last Updated:07/15/2021

This study is designed to evaluate the safety and pharmacokinetics of BTCT4465A when administered as a single agent by intravenous (IV) infusion to participants with relapsed or refractory B-cell NHL and CLL. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.

  • Start Date08/18/2020
  • End Date10/31/2020

Trial Purpose and Description

Primary Outcome Measures:

  • Incidence of dose-limiting toxicities (DLTs) [ Time Frame: During Cycle 1 (up to 21 days) ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: From Cycle 1 Day 1 until 90 days after the last infusion (up to approximately 9 months) ] [ Designated as safety issue: No ]
  • Area under the concentration-time curve (AUC) of BTCT4465A [ Time Frame: Pre-dose and post-dose on Days 1, 8, and 15 on Cycle 1 and on Days 1 and 8 of Cycles 2, 4, 6, and 8 and within 30 days after the last infusion (up to approximately 7 months) ] [ Designated as safety issue: No ]
  • Maximum serum concentration (Cmax) of BTCT4465A [ Time Frame: Pre-dose and post-dose on Days 1, 8, and 15 on Cycle 1 and on Days 1 and 8 of Cycles 2, 4, 6, and 8 and within 30 days after the last infusion (up to approximately 7 months) ] [ Designated as safety issue: No ]
  • Minimum serum concentration (Cmin) of BTCT4465A [ Time Frame: Pre-dose and post-dose on Days 1, 8, and 15 on Cycle 1 and on Days 1 and 8 of Cycles 2, 4, 6, and 8 and within 30 days after the last infusion (up to approximately 7 months) ] [ Designated as safety issue: No ]
  • Clearance (CL) of BTCT4465A [ Time Frame: Pre-dose and post-dose on Days 1, 8, and 15 on Cycle 1 and on Days 1 and 8 of Cycles 2, 4, 6, and 8 and within 30 days after the last infusion (up to approximately 7 months) ] [ Designated as safety issue: No ]
  • Volume of distribution at steady state (Vss) of BTCT4465A [ Time Frame: Pre-dose and post-dose on Days 1, 8, and 15 on Cycle 1 and on Days 1 and 8 of Cycles 2, 4, 6, and 8 and within 30 days after the last infusion (up to approximately 7 months) ] [ Designated as safety issue: No ]

Eligibility Criteria

Inclusion Criteria:

  • Adults at least 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy at least 12 weeks
  • Dose-escalation stage: Grade 1 to 3b follicular lymphoma (FL), marginal zone lymphoma (MZL), transformed FL, Richter's transformation, diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), or CLL
  • Dose-expansion stage: DLBCL, transformed FL, Grade 1 to 3a FL, MZL, or CLL
  • Adverse events from prior anti-cancer therapy resolved to Grade 1 or better
  • Adequate hepatic, hematologic, and renal function
  • For participants and partners of childbearing potential, agreement to remain abstinent or utilize effective contraception

Exclusion Criteria:

  • Pregnant or lactating women
  • Monoclonal antibody, radioimmunoconjugate, antibody-drug conjugate, radiotherapy, chemotherapy, or other investigational anti-cancer agent within 4 weeks prior to study drug
  • Systemic immunotherapy within 12 weeks or 5 half-lives of drug prior to study drug
  • Systemic immunosuppressive medication within 2 weeks prior to study drug
  • Autologous stem cell transplantation (SCT) within 100 days prior to study drug, or any prior allogeneic SCT or solid organ transplantation
  • Autoimmune disease with the exception of controlled/treated hypothyroidism, disease-related immune thrombocytopenic purpura, or hemolytic anemia
  • History of confirmed progressive multifocal leukoencephalopathy (PML)
  • History of central nervous system (CNS) lymphoma or other CNS disease
  • Significant cardiovascular or pulmonary disease
  • Current infection, or prior infection requiring IV antibiotics and/or hospitalization within 4 weeks prior to study drug
  • Major surgery within 4 weeks prior to study drug
  • Hepatitis B or C or human immunodeficiency virus (HIV)
  • Receipt of a live attenuated vaccine within 4 weeks prior to study drug
  • History of drug or alcohol abuse within 12 weeks prior to Screening

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