A Phase 2a Study of HT-6184 in Subjects With IPSS-R Very Low, Low or Intermediate Risk MDS and Anemia

NCT07052006 | Active Not Recruiting Phase 2

• 2 other identifiers: HT-6184-MDS-001CTRI/2023/11/059758
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 10

Brief Summary

This research is being conducted to asses if HT-6184 is effective in the treatment of Very Low, Low, or Intermediate Risk Myelodysplastic Syndrome (MDS) and Symptomatic Anemia. The study includes a 28-day Screening Period followed by a 16- or 32-week Treatment Period. Participants will be monitored at each cycle for drug tolerance, safety, and hematological response. A response assessment will occur after 16 weeks of study treatment.

Conditions

Anemia in Myelodysplastic Syndromes; Myelodysplastic Syndrome

Keywords

Very Low-risk MDS; Low-risk MDS; Intermediate-risk MDS; Symptomatic anemia

Outcome Measures

Primary Outcomes (1)

• The rate of hematological improvement.

  16 weeks

Study Arms (1)

HT-6184

EXPERIMENTAL

Drug: HT-6184

Interventions

HT-6184 DRUG

Oral HT-6184

Also known as: Ofirnoflast

HT-6184

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age.
• Signed Informed Consent Form (ICF).
• Adequate organ function.
• A documented diagnosis of MDS or non-proliferative Myelodysplastic/myeloproliferative neoplasm (MDS/MPN).
• Less than 10% bone marrow myeloblasts.
• Refractory or intolerant of, or ineligible for treatment with an erythroid stimulating agent (ESA).
• Prior ESA treatment must have been discontinued ≥ 2 weeks prior to date of study treatment.
• Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2.
• Subjects must have symptomatic anemia.
• Subjects with NGS (Next-generation sequencing) myeloid-specific somatic gene mutation profile with ≥ 5 % quantitation of clone size by variant allele frequency (VAF).
• Women of child-bearing potential using an acceptable double-barrier method of contraception.
• Male subjects who are using an acceptable method of contraception.

You may not qualify if:

• Other causes of anemia such as iron deficiency.
• Clinically significant anemia resulting from B12 or folate deficiencies, autoimmune or hereditary hemolysis, or gastrointestinal bleeding.
• Women must not be pregnant or breastfeeding.
• Presence of concomitant intercurrent illness which, in the opinion of the Investigator, would compromise safe participation in the study.
• Secondary MDS.
• Treatment with cytotoxic chemotherapeutic agents or experimental agents for the treatment of MDS within 4 weeks of study treatment.
• Chronic use of systemic corticosteroids for comorbid or study disease condition within last 4 weeks of study treatment.
• Prior history of malignancy other than MDS.
• Subject has undergone a stem cell, bone marrow or solid organ transplant
• Subjects with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
• Prior treatment with disease modifying agents.
• Participation in any clinical study within 90 days before the first dose of Investigational Product.
• Loss of ≥ 350 ml of blood within 90 days before the first dose of Investigational Product.

Sponsors & Collaborators

• Halia Therapeutics, Inc.: lead

Study Sites (10)

Hemato Oncology Clinica Ahmedabad Pvt. Ltd. Vedanta Institute of Medical Sciences

Ahmedabad, Gujarat, 380009, India

Location

Shalby Hospital

Ahmedabad, Gujarat, 380015, India

Location

Malabar Cancer Center

Kannur, Kerala, 670103, India

Location

HCG Cancer Center Vizag

Visakhapatnam, Krishna, 530040, India

Location

Dr. Bafna's Star Superspeciality Clinic and Hospital

Kolhāpur, Maharashtra, 416005, India

Location

All India Institute of Medical Sciences

Dehradun, Rishkesh, 249203, India

Location

Meenakshi Mission Hospital and Research Centre

Madurai, Tamil Nadu, 625107, India

Location

Apollo Cancer Centre

Hyderabad, Telangana, 500033, India

Location

Nil Ratan Sircar Medical College and Hospital

Kolkata, West Bengal, 700014, India

Location

Tata Medical Center

Kolkata, West Bengal, 700160, India

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 4, 2025
• Study Start: December 9, 2023
• Primary Completion: January 8, 2026
• Study Completion (Estimated): May 25, 2026
• Last Updated: April 17, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (10)