A Study to Evaluate the Safety and Effectiveness of JBH492 in Patients with Chronic Lymphocytic Leukemia and Non-Hodgkin's Lymphoma

Overview

About this study

The purpose of this First-In-Human study is to assess the safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary effectiveness of JBH492 as single agent.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

For Patients with CLL

  • Confirmed diagnosis of chronic lymphocytic leukemia (CLL).
  • Must have received at least two (2) prior therapy regimens.
  • Patients with Richter's transformation should have failed standard therapy.

For Patients with NHL

  • Histologically confirmed diagnosis of B- or T-cell non-Hodgkins lymphoma (NHL).
  • Must have a site of disease amenable to biopsy, and be suitable and willing to undergo study required biopsies at screening and during therapy.
  • The histologic subtypes of NHL that are permitted in the dose escalation part were specified.
  • Must have received at least two (2) prior therapy regimens.
  • Patients with indolent lymphoma must have received and failed standard-of-care therapy or be intolerant or ineligibile to approved therapies and must be in need of therapeutic intervention.
  • Patients with prior CART T-cell therapy will be permitted on this trial 30 days after CART infusion and meet protocol defined inclusion/exclusion criteria.

Exclusion Criteria:

Applicable to both CLL and NHL

  • History of anaphylactic or other severe hypersensitivity/infusion reactions to ADCs, monoclonal antibodies (mAbs) and/or their excipients such that the patient in unable to tolerate immunoglobulin/monoclonal antibody administration.
  • Any prior history of treatment with maytansine (DM1 or DM4)-based ADC.
  • Known intolerance to a maytansinoid.
  • Patients with any active or chronic corneal disorders.
  • Patients who have any other condition that precludes monitoring of the retina or fundus.
  • Patients with active CNS involvement are excluded, except if the CNS involvement has been effectively treated and provided that local treatment was > 4 weeks before enrollment. Patients that have been effectively treated for CNS disease and are stable under systemic therapy may be enrolled provided all other inclusion and exclusion criteria are met.
  • Impaired cardiac function or clinically significant cardiac disease.
  • Known history of Human Immunodeficiency Virus (HIV) infection, Active Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Allison Rosenthal, D.O.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

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Rochester, Minn.

Mayo Clinic principal investigator

Grzegorz Nowakowski, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

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More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20486464

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