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Monoclonal Antibodies

IKS03 for B-Cell Lymphoma

Phase 1
Recruiting
Research Sponsored by Iksuda Therapeutics Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Part 1: documented B cell NHL (any subtype except Burkitt lymphoma, Waldenström macroglobulinemia, chronic lymphocytic leukemia); previously confirmed CD19-positive if feasible
ECOG performance status 0 or 1; anticipated life expectancy ≥ 10 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 42 months
Awards & highlights

Study Summary

This trial will study a new cancer drug to check safety, how it works, how well it works & more in B cell NHL patients.

Who is the study for?
Adults over 18 with advanced B cell non-Hodgkin lymphoma, excluding certain types like Burkitt lymphoma. They must have tried at least two other treatments without success and need further therapy but not immediate cytoreduction. Participants should be in a stable condition (ECOG status 0 or 1) and willing to use effective contraception.Check my eligibility
What is being tested?
IKS03, an experimental drug targeting CD19 on cancer cells, is being tested for safety, tolerability, dosage levels, effectiveness against the cancer, immune response it may cause, and how the body processes it.See study design
What are the potential side effects?
Specific side effects of IKS03 are not listed but generally could include reactions at the infusion site, fatigue, nausea or other digestive issues based on similar therapies. Close monitoring will identify any adverse effects during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lymphoma is B cell type but not Burkitt, Waldenström, or CLL, and it's CD19-positive.
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I am mostly active and doctors expect me to live for at least 10 more weeks.
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I need treatment that affects my whole body but don't need surgery to remove tumors right away.
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My NHL has not responded to at least 2 treatments and there's no cure available.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 42 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 42 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (Part 2)
Recommended Dose for Expansion (Part 1)
Secondary outcome measures
Determine recommended Phase 2 dose (RP2D) (Part 2)
Evaluation of the immunogenicity of IKS03 (Part 1 and 2)
Plasma Concentrations of IKS03 (Part 1 and 2)

Trial Design

5Treatment groups
Experimental Treatment
Group I: Dose Expansion: Other B cell lymphoma (B-NHL not otherwise specified [NOS])Experimental Treatment1 Intervention
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.
Group II: Dose Expansion: Mantle Cell Lymphoma ParticipantsExperimental Treatment1 Intervention
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.
Group III: Dose Expansion: Follicular Cell Lymphoma ParticipantsExperimental Treatment1 Intervention
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.
Group IV: Dose Expansion: Diffuse-Large B-Cell Lymphoma ParticipantsExperimental Treatment1 Intervention
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.
Group V: Dose Escalation Cohort (Part 1)Experimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Iksuda Therapeutics Ltd.Lead Sponsor
1 Previous Clinical Trials
165 Total Patients Enrolled
Paul I Nadler, MDStudy DirectorIksuda Therapeutics
1 Previous Clinical Trials
19 Total Patients Enrolled

Media Library

IKS03 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05365659 — Phase 1
Mantle Cell Lymphoma Research Study Groups: Dose Expansion: Follicular Cell Lymphoma Participants, Dose Escalation Cohort (Part 1), Dose Expansion: Mantle Cell Lymphoma Participants, Dose Expansion: Diffuse-Large B-Cell Lymphoma Participants, Dose Expansion: Other B cell lymphoma (B-NHL not otherwise specified [NOS])
Mantle Cell Lymphoma Clinical Trial 2023: IKS03 Highlights & Side Effects. Trial Name: NCT05365659 — Phase 1
IKS03 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05365659 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings left in this research project?

"As per clinicaltrials.gov, this medical trial is not seeking participants at the present time. The protocol was first posted on June 1st 2023 and most recently updated on May 9th of the same year. However, there are a plethora of other studies currently in need of volunteers with 1803 trials actively recruiting right now."

Answered by AI

Has the Dose Escalation Cohort (Part 1) obtained FDA authorization?

"The safety of Dose Escalation Cohort (Part 1) was assessed at a score of 1, as the data regarding its efficacy and security is still quite limited."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas
2023. "IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05365659.
~93 spots leftby Sep 2025
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