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A Phase 1, First-In-Human, Open-Label, Dose-Escalating Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Ascending Intravenous Doses of BITR2101 (Anti-TNFR2) in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma Including Cutaneous and Peripheral T Cell Lymphoma

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Trial Profile

A Phase 1, First-In-Human, Open-Label, Dose-Escalating Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Ascending Intravenous Doses of BITR2101 (Anti-TNFR2) in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma Including Cutaneous and Peripheral T Cell Lymphoma

Status: Not yet recruiting
Phase of Trial: Phase I

Latest Information Update: 29 Apr 2024

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At a glance

  • Drugs BITR 2101 (Primary) ; Tislelizumab (Primary)
  • Indications Adult T-cell leukaemia-lymphoma; B-cell lymphoma; Cutaneous T-cell lymphoma; Diffuse large B cell lymphoma; Mantle-cell lymphoma; Marginal zone B-cell lymphoma; Non-Hodgkin's lymphoma; Peripheral T-cell lymphoma
  • Focus Adverse reactions; First in man
  • Sponsors Boston Immune Technologies and Therapeutics
  • Most Recent Events

    • 23 Apr 2024 Status changed from planning to not yet recruiting.
    • 18 Aug 2023 According to a Boston Immune Technologies and Therapeutics media release, the US Food and Drug Administration (FDA) has cleared Investigational New Drug application (IND) for a Phase I trial of BITT2101 (anti-TNFR2) in patients with relapsed or refractory Non-Hodgkins lymphomas.
    • 13 Feb 2023 According to a Boston Immune Technologies and Therapeutics media release, IND filing for BITR-2101 is anticipated by the end of Q1 2023.

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