Is NCT07672769 recruiting in New Haven, CT?

Yes, NCT07672769 is currently recruiting participants at its New Haven, CT location. This higher risk myelodysplastic syndromes clinical trial is actively enrolling qualified participants.

Is participation in this New Haven 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.

Higher Risk Myelodysplastic Syndromes Clinical Trial in New Haven, CT

Q: How do I join the higher risk myelodysplastic syndromes clinical trial in New Haven?

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

About This Higher Risk Myelodysplastic Syndromes Study in New Haven

This Phase IIb study (BEXERA) will evaluate the safety and efficacy of bexmarilimab (FP-1305), an antibody targeting Clever-1, given in combination with azacitidine compared with azacitidine plus placebo in adults with treatment-naïve higher-risk myelodysplastic syndromes (HR-MDS). Participants will be randomized to receive bexmarilimab at one of two dose levels (1 mg/kg or 3 mg/kg) plus azacitidine, or placebo plus azacitidine. The primary aim is to select the recommended dose of bexmarilimab for subsequent development based on a predefined integration of clinical response and safety/tolerability.

Sponsor: Faron Pharmaceuticals Ltd

Who Can Participate

Inclusion Criteria

Participant provides written informed consent.

Participant is ≥18 years of age.

Participant has newly diagnosed MDS with morphologically confirmed HR-MDS as defined according to 2022 World Health Organization classification (5th Edition, Annex 7).

IPSS-M classification of moderately high risk, high risk, and very high risk.

\<20% bone marrow blasts per bone marrow biopsy/aspirate at screening

Participant is eligible for azacitidine per local practice and willing to initiate trial therapy.

Participant has ECOG performance score 0 to 2.

Participant has life expectancy ≥3 months.

Participant has adequate organ function: creatinine clearance ≥30 mL/min (Cockcroft-Gault); indirect (unconjugated) bilirubin ≤1.5 times the upper limit of normal (ULN) (unless related to Gilbert's syndrome, in which case the indirect bilirubin levels must be \<3×ULN for inclusion); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤3×ULN.

Participant has baseline leukocyte count of \<20×109/L. Hydroxycarbamide use is permitted to meet this criterion.

Women of childbearing potential have a negative pregnancy test; participants of childbearing potential (and their partners) agree to use highly effective contraception during treatment and for ≥6 months after last dose.

Participant is willing and able to comply with protocol procedures and follow up.

Exclusion Criteria

Participant has a previous diagnosis of AML, has transformed to AML, or has MDS subtypes outside the scope or overlapping myeloid neoplasms: MDS evolved from pre-existing myeloproliferative neoplasms (MPN); MDS/MPN overlap (e.g., chronic myelomonocytic leukemia, acute chronic myeloid leukemia, juvenile myelomonocytic leukemia, unclassifiable); advanced myelofibrosis (MF Grade ≥3); or severe autoimmune hemolysis.

Participants who are considered appropriate candidates for immediate allogeneic haematopoietic stem cell transplantation (HSCT) at the time of screening are excluded, irrespective of transplant timing, donor availability, or planned bridging therapy. Determination of transplant candidacy should be based on institutional standards and routine clinical practice, including assessment of individual clinical factors such as age, performance status, comorbidities, organ function, disease risk, and donor suitability.

Participants with ≥20% blasts in peripheral blood or bone marrow or evidence of myeloid sarcoma (extramedullary AML).

Participant has a lack of screening cytogenetic data or demonstrated normal karyotype per local or central analysis, should the patient have \<5% blasts at screening.

Participant has received previous lines of anticancer therapy for MDS (disease-modifying therapy), including HMAs (e.g., azacitidine, decitabine), chemotherapy, or HSCT. Supportive care (e.g., transfusions, growth factors) is permitted.

Participant has clinically significant cardiac disease: recent myocardial infarction within 12 months; symptomatic congestive heart failure (New York Heart Association Class III or IV) or left ventricular ejection fraction (LVEF) \<40%; uncontrolled clinically significant arrhythmias; or congenital/familial long-QT syndrome or pre-excitation syndrome.

Participant has active, uncontrolled infection requiring IV antimicrobials; known active invasive fungal infection; uncontrolled severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection per local standards.

Participant has known active central nervous system (CNS) involvement by myeloid malignancy

All prior allo-HSCT within 6 months before Screening; ongoing clinically significant graft versus host disease (GVHD) requiring systemic immunosuppression.

Participant has active autoimmune disease requiring systemic therapy or requiring ≥10 mg/day prednisone (or equivalent) within 14 days prior to first dose; topical/inhaled/ophthalmic steroids permitted. (Immune conditions such as type 1 diabetes, controlled thyroid disease, vitiligo, psoriasis, alopecia are not exclusions.)

Participant has clinically relevant hepatic disease (e.g., Child-Pugh C) or ALT/AST \>3×ULN and bilirubin exceeding inclusion thresholds (indirect \[unconjugated\] bilirubin \>1.5×ULN \[unless related to Gilbert's syndrome, in which case the indirect bilirubin levels must be \>3×ULN\]); persistent chronic ulcers with high risk of infection per investigator's assessment.

Participant has received recent non-MDS related anticancer therapy or investigational agents within drug-specified washout periods (e.g., \<21 days from last IV/SC cytotoxic, \<14 days or \<5 half-lives for small-molecule therapy, \<4 weeks for other immunotherapies).

Participant has a history of another malignancy that is active, progressing, or has required systemic treatment within the past 2 years of screening, excluding non-melanoma skin cancer, carcinoma in situ treated with curative intent.

Participant has known uncontrolled human immunodeficiency virus, active hepatitis B virus, or hepatitis C virus with high-level viremia; participants with controlled viral infections on stable therapy may be eligible per local guidance.

Participant is pregnant or lactating.

Participant has prior exposure to bexmarilimab.

Participant has any condition, including psychiatric or substance-use disorder, that in the investigator's judgment would compromise informed consent, compliance, or interpretation of trial results.

Participant has a history of hypersensitivity to compounds related to immunotherapy or to any of their excipients.

Participant has undergone major surgery within 4 weeks of Cycle 1 Day 1.

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 New Haven?

Yes, this clinical trial (NCT07672769) has an active research site in New Haven, CT 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.

Higher Risk Myelodysplastic Syndromes Treatment Options in New Haven, CT

If you're searching for higher risk myelodysplastic syndromes treatment options in New Haven, CT, this clinical trial (NCT07672769) 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 New Haven research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced higher risk myelodysplastic syndromes 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 higher risk myelodysplastic syndromes clinical trials near you to find additional studies recruiting in your area.

Higher Risk Myelodysplastic Syndromes Clinical Trial in New Haven, CT

Expert Care in New Haven

IRB Approved

No-Cost Care

Apply for This New Haven Location

Why Participate?

Simple Process