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Status:

RECRUITING

IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas

Lead Sponsor:

Iksuda Therapeutics Ltd.

Conditions:

B-cell Non-Hodgkin Lymphoma

Diffuse Large B Cell Lymphoma

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

This first-in-human study will evaluate the recommended dose for further clinical development, safety, tolerability, antineoplastic activity, immunogenicity, pharmacokinetics and pharmacodynamics of I...

Detailed Description

The study will consist of 2 parts: dose-escalation (Part 1) and dose-expansion (Part 2). The dose-escalation part (Part 1) of the study is to evaluate the safety and tolerability of increasing dose le...

Eligibility Criteria

Inclusion

  • Males or females, ≥ 18 years of age
  • Part 1: documented B cell NHL (any subtype except Burkitt lymphoma, Waldenström macroglobulinemia, chronic lymphocytic leukemia); previously confirmed CD19-positive if feasible
  • Part 2: documented B cell NHL (subtypes to be determined); confirmed CD19-positive; possible expansion cohorts may include:
  • Diffuse large B cell lymphoma (including germinal center B cell type, activated B cell type)
  • Follicular lymphoma (including duodenal-type follicular lymphoma)
  • Mantle cell lymphoma
  • B cell lymphomas not specified
  • If B cell NHL subtype likely to have bone marrow involvement must be willing to undergo bone marrow biopsy in the event of an on-study complete response to confirm response
  • NHL that is relapsed, refractory to, or intolerant of existing therapy(ies) with known curative potential, or for which no standard therapy is available; must have received at least 2 prior lines of systemic therapy
  • Must be in need of systemic treatment and not require immediate cytoreductive therapy
  • Part 1: measurable or non-measurable disease
  • Part 2: measurable disease according to The Revised Criteria/Lugano Classification
  • Part 1: screening tumor biopsy requested, but optional; Part 2: patient must agree to screening tumor biopsy
  • ECOG performance status 0 or 1; anticipated life expectancy ≥ 10 weeks
  • Women of childbearing potential and fertile men agreeing to use two effective methods of contraception (including a highly effective method of contraception); women beginning 2 weeks prior to the first dose, men beginning prior to the first dose, and both continuing until 8 months after the last dose of study drug; male patients must also agree to refrain from sperm donation during this period.
  • Ability to understand and give written informed consent

Exclusion

  • Women who are pregnant or intending to become pregnant before, during, or within 8 months after the last dose of study drug; women who are breastfeeding
  • Patients documented to be CD19-negative
  • Central nervous system (CNS) lymphoma, leptomeningeal infiltration, or spinal cord compression not controlled by prior surgery or radiotherapy; symptoms suggesting CNS involvement
  • Part 2: History of another malignancy within 2 years, with the exception of:
  • Treated, non-melanoma skin cancers
  • Treated carcinoma in situ (e.g., breast, cervix)
  • Controlled, superficial carcinoma of the urinary bladder
  • T1a or b prostate carcinoma treated according to standard of care, with PSA within normal limits
  • Papillary thyroid carcinoma Stage I treated surgically for cure
  • Any of the following hematologic abnormalities at baseline (transfusion allowed \> 5 days previous):
  • Hemoglobin \< 8.0 g/dL
  • Absolute neutrophil count \< 1,000 per mm3
  • Platelet count \< 75,000 per mm3
  • Any of the following laboratory abnormalities at baseline:
  • Total bilirubin \> 1.5 × upper limit of normal (ULN); \> 3 × ULN if with Gilbert's Syndrome
  • AST or ALT \> 3 × ULN; \> 5 × ULN if due to hepatic involvement by tumor
  • Estimated GFR ≤ 60 mL/min corrected for BSA
  • Albuminuria defined as urine albumin to creatinine ratio \< 30 mg/g or \< 3 mg/mmol) by spot urine albumin
  • Any of the following coagulation parameter abnormalities at baseline unless on a stable dose of anticoagulant therapy for a prior thrombotic event:
  • PT or INR \> 1.5 × ULN; \> 3× ULN if anticoagulated)
  • PTT \> 1.5 × ULN; \> 3× ULN if anticoagulated
  • Any of the following laboratory abnormalities at baseline aimed at assessing renal function:
  • Estimated glomerular filtration rate (eGFR) ≤ 60 mL/min, corrected for BSA.
  • Albuminuria defined as urine albumin to creatinine ratio (UACR) ≥ 30 mg/g or ≥ 3 mg/mmol by spot urine albumin
  • Patients with:
  • Active thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 4 weeks unless adequately treated and stable
  • Active uncontrolled bleeding or a known bleeding diathesis
  • Significant cardiovascular disease or condition, including:
  • Congestive heart failure or angina pectoris requiring therapy
  • Ventricular arrhythmia requiring therapy or other uncontrolled arrhythmia
  • Severe conduction disturbance (e.g., 3rd degree heart block)
  • QTc interval ≥ 480 milliseconds
  • Left ventricular ejection fraction below the lower limit of normal or \< 50% by MUGA scan or echocardiogram
  • Class III or IV cardiovascular disease according to the New York Heart Association Functional Classification
  • History of acute coronary syndromes (e.g., MI, unstable angina), coronary angioplasty, stenting, or bypass within 6 months
  • Significant liver disease, including:
  • Non-infectious hepatitis
  • Hepatic cirrhosis (Child-Pugh Class B and Class C)
  • Significant pulmonary disease or condition, including:
  • Significant symptomatic COPD, as assessed by the Investigator
  • History or any current evidence on imaging studies of interstitial lung disease, pulmonary fibrosis
  • History of pulmonary inflammatory disease, pneumonitis, ARDS
  • History of pneumonia within 6 months
  • Significant corneal disease or condition, including history of or current evidence of keratitis
  • Clinically significant CNS disease or condition including PML, epilepsy, vasculitis, or neurodegenerative disease. Also including TIA or stroke within 6 months
  • Known HIV infection or AIDS
  • Active hepatitis B virus or hepatitis C virus infection
  • Any other serious/active/uncontrolled infection, any infection requiring parenteral antibiotics, or unexplained fever \> 38ºC within 2 weeks
  • Autoimmune disease or condition requiring systemic steroids or other immunosuppressive medications
  • Unresolved Grade \> 1 AE associated with any prior antineoplastic therapy (except persistent Grade 2 alopecia, peripheral neuropathy, decreased hemoglobin, neutropenia, lymphopenia, hypomagnesemia, and/or endocrine end-organ failure being adequately managed by HRT)
  • Known or suspected hypersensitivity to any of the excipients of formulated study drug
  • Inadequate recovery from a surgical procedure, or a major surgical procedure within 4 weeks
  • Any other serious, life-threatening, or unstable preexisting medical condition, including significant organ system dysfunction, or clinically significant laboratory abnormality(ies)
  • A psychiatric disorder or altered mental status that would preclude understanding of the informed consent process
  • Drugs and Other Treatments to be Excluded:
  • Receipt of:
  • Any CD19-targeted therapy within 3 months
  • Any tumor vaccine within 6 weeks (must have progressed if previously received)
  • Prior autologous/allogeneic CAR-T therapy if known to be CD19-negative after
  • Any other antineoplastic agent for the primary malignancy without delayed toxicity within 4 weeks or 5 plasma half-lives, whichever is shortest (except nitrosoureas and mitomycin C within 6 weeks)
  • Any other investigational treatments within 4 weeks
  • Drugs known to impair renal function, including:
  • NSAIDS within 3 days
  • Aminoglycoside antibiotics, amphotericin B, etc. within 1 week
  • Bisphosphonates within 1 month
  • Prior solid organ transplant
  • Allogeneic HSCT within 6 months, or:
  • If receiving immunosuppression
  • If with active evidence of GVHD
  • Autologous hematopoietic stem cell transplantation (HSCT) within 3 months
  • Radiotherapy:
  • To target lesions within 4 weeks unless progression of the lesion has been documented
  • To non-target lesions within 1 week
  • Live/live-attenuated vaccines against infectious diseases within 4 weeks
  • Immunosuppressive or systemic glucocorticoid therapy (\> 10 mg prednisone daily or equivalent) within 2 weeks
  • Prophylactic use of hematopoietic growth factors within 1 week
  • Herbal therapies and supplements within 2 weeks
  • Strong inhibitors of cytochrome P450 within 2 weeks

Key Trial Info

Start Date :

September 5 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2028

Estimated Enrollment :

140 Patients enrolled

Trial Details

Trial ID

NCT05365659

Start Date

September 5 2023

End Date

September 1 2028

Last Update

October 1 2025

Active Locations (13)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 4 (13 locations)

1

University of Maryland Baltimore

Baltimore, Maryland, United States, 21201

2

Westmead Hospital

Westmead, New South Wales, Australia, 2145

3

Royal Adelaide Hospital

Adelaide, South Australia, Australia

4

Royal Hobart Hospital

Hobart, Tasmania, Australia, 7000