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RecruitingLast updated: 8 January 2024

This study is seeking to determine the recommended dose level, safety and effectiveness of a new drug (called ABBV-319) in people with relapsed or refractory, diffuse large B-cell lymphoma, follicular lymphoma, or chronic lymphocytic leukaemiaA First In Human Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-319 in B-cell Malignancies

Clinical summary

Summary

This study has two phases: Dose Escalation and Dose Expansion.

In the Dose Escalation Phase, participants will receive escalating intravenously infused doses of ABBV-319 in 21-day cycles, until the recommended phase 2 dose (RP2D) is determined.

In the Dose Expansion Phase, participants will receive intravenously infused ABBV-319 in 21-day cycles at the RP2D determined in the previous phase.

Conditions

This trial is treating patients with relapsed or refractory diffuse large B-cell lymphoma, follicular lymphoma, and chronic lymphocytic leukaemia

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I

More information

Trial Identifiers

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Trial sponsor

AbbVie

Scientific Title

A First In Human Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-319 in B-cell Malignancies

Eligibility

Inclusion

  • For dose escalation (Part 1) only: Participants with documented diagnosis of B-cell malignancies including those with histology based on criteria established by the World Health Organization (WHO), and measurable disease requiring treatment, as per the protocol.
  • For the relapsed or refractory diffuse large b-cell lymphoma (DLBCL), follicular lymphoma (FL), and Chronic lymphocytic leukemia (CLL) dose expansion cohorts (Part 2) only: Participants with documented diagnosis of one of the B-cell malignancies noted in the protocol with histology based on criteria established by the WHO, and measurable disease requiring treatment, as per the protocol.
  • Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Laboratory values meeting the criteria noted in the protocol.
  • For participants previously treated with a CD19-targeting therapy (eg, CD19 monoclonal antibody) a core or excision tumor biopsy subsequent to the most recent CD19-targeting therapy must be collected.
  • Participant must have measurable disease, as defined by the 2014 Lugano Classification.

Exclusion

  • Known active central nervous system (CNS) disease, or primary CNS lymphoma.
  • Know active infection or clinically significant uncontrolled conditions as per the protocol.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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