Is NCT05365659 recruiting in Baltimore, MD?

Yes, NCT05365659 is currently recruiting participants at its Baltimore, MD location. This b-cell non-hodgkin lymphoma clinical trial is actively enrolling qualified participants.

How do I join the b-cell non-hodgkin lymphoma clinical trial in Baltimore?

To join this clinical trial in Baltimore, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Baltimore clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

B-cell Non-Hodgkin Lymphoma Clinical Trial in Baltimore, MD

About This B-cell Non-Hodgkin Lymphoma Study in Baltimore

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).

Sponsor: Iksuda Therapeutics Ltd.

Who Can Participate

Inclusion Criteria

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 Criteria

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Baltimore?

Yes, this clinical trial (NCT05365659) has an active research site in Baltimore, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

B-cell Non-Hodgkin Lymphoma Treatment Options in Baltimore, MD

If you're searching for b-cell non-hodgkin lymphoma treatment options in Baltimore, MD, this clinical trial (NCT05365659) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Baltimore research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced b-cell non-hodgkin lymphoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all b-cell non-hodgkin lymphoma clinical trials near you to find additional studies recruiting in your area.

B-cell Non-Hodgkin Lymphoma Clinical Trial in Baltimore, MD

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