IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Iksuda Therapeutics Ltd.
Study ID
NCT05365659
Phase
PHASE1
Status
Recruiting
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Conditions

  • B-cell Lymphoma
  • B-cell Non-Hodgkin Lymphoma
  • Diffuse Large B Cell Lymphoma
  • Follicular Lymphoma
  • Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IKS03 — DRUG
    IKS03 is a human monoclonal antibody (Ab) targeting CD19 linked to a pyrrolobenzodiazepine (PBD) pro-drug as the cytotoxic agent.

Study Details

This first-in-human study will evaluate the recommended dose for further clinical development, safety, tolerability, antineoplastic activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS03, a CD19 targeting antibody-drug conjugate, in patients with advanced B cell non-Hodgkin lymphoma (NHL).

Key Dates

Start date
Sep 5, 2023
Status verified
Sep 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2028

Study Design

Enrollment
140 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Cohort (Part 1)
    Each patient will receive repeat doses (by intravenous (IV) infusions) on Day 1 of each 21-day cycle. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criteria is met.
  • Experimental: Dose Expansion: Diffuse-Large B-Cell Lymphoma Participants
    Each patient will receive IKS03 at the recommended dose for expansion (RDE) defined in Part 1 on Day 1 of each 21-day cycle. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criteria is met.
  • Experimental: Dose Expansion: Follicular Cell Lymphoma Participants
    Each patient will receive IKS03 at the recommended dose for expansion (RDE) defined in Part 1 on Day 1 of each 21-day cycle. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criteria is met.
  • Experimental: Dose Expansion: Mantle Cell Lymphoma Participants
    Each patient will receive IKS03 at the recommended dose for expansion (RDE) defined in Part 1 on Day 1 of each 21-day cycle. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criteria is met.
  • Experimental: Dose Expansion: Other B cell lymphoma (B-NHL not otherwise specified [NOS])
    Each patient will receive IKS03 at the recommended dose for expansion (RDE) defined in Part 1 on Day 1 of each 21-day cycle. Participants may continue on study until disease progression, unacceptable toxicity, or other withdrawal criteria is met.

Primary Outcome Measure

Recommended Dose for Expansion (Part 1) [ Time Frame: Up to 20 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland BaltimoreBaltimoreMaryland21201-

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By research site
University of Maryland Baltimore· Baltimore, MD

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