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New treatment option for B-cell Non-Hodgkin Lymphoma
Official title IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas
ClinicalTrials.gov ID: NCT05365659
What this study is testing
What is IKS03?
IKS03 is an investigational medicine, being studied as a potential treatment for b-cell non-hodgkin lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Males or females, ≥ 18 years of age
- Part 1: documented B cell NHL (any subtype except Burkitt lymphoma, Waldenström macroglobulinemia, chronic lymphocytic leukemia); previously...
- 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)
You likely can't join if
- 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...
- Patients documented to be CD19-negative
- Central nervous system (CNS) lymphoma, leptomeningeal infiltration, or spinal cord compression not controlled by prior surgery or radiotherapy...
- 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)
See the full eligibility criteria
Who can join
- 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...
- Ability to understand and give written informed consent
What rules you out
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
- Westmead, New South Wales, Australia
- Adelaide, South Australia, Australia
- Hobart, Tasmania, Australia
- Perth, Western Australia, Australia
- Montreal, Quebec, Canada
- Candiolo, Italy
- Milan, Italy
- Badalona, Spain
- Madrid, Spain
- Salamanca, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States; Westmead, New South Wales, Australia; Adelaide, South Australia, Australia; Hobart, Tasmania, Australia; Perth, Western Australia, Australia; Montreal, Quebec, Canada and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.