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Active, not recruitingNCT07052006Updated Sep 17, 2026

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

A Phase 2 interventional study of HT-6184 in Myelodysplastic Syndrome and Anemia in Myelodysplastic Syndromes, sponsored by Halia Therapeutics, Inc.. Active, not recruiting at 10 sites in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Halia Therapeutics, Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Dec 2023, registered Jun 2025).
Phase
Phase 2
Study type
Interventional
Enrollment
37
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Myelodysplastic Syndrome
  • Anemia in Myelodysplastic Syndromes

Keywords

  • Very Low-risk MDS
  • Low-risk MDS
  • Intermediate-risk MDS
  • Symptomatic anemia
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In context

Myelodysplastic Syndromes

2,124 studies on the registry are indexed under Myelodysplastic Syndromes; 320 are open to participants now.

This study's enrollment of 37 is close to the median of 39 across 1,740 interventional studies indexed under Myelodysplastic Syndromes.

Browse Myelodysplastic Syndromes studies →

Lead sponsor

Halia Therapeutics, Inc. is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    HT-6184

    Drug: HT-6184

Interventions

  • DrugHT-6184

    Oral HT-6184

    Also known as: Ofirnoflast

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What researchers measure

Primary outcomes

  1. The rate of hematological improvement.

    Time frame: 16 weeks

07

Study locations

10 sites
  • Hemato Oncology Clinica Ahmedabad Pvt. Ltd. Vedanta Institute of Medical Sciences
    Ahmedabad, Gujarat 380009, India
  • Shalby Hospital
    Ahmedabad, Gujarat 380015, India
  • Malabar Cancer Center
    Kannur, Kerala 670103, India
  • HCG Cancer Center Vizag
    Visakhapatnam, Krishna 530040, India
  • Dr. Bafna's Star Superspeciality Clinic and Hospital
    Kolhāpur, Maharashtra 416005, India
  • All India Institute of Medical Sciences
    Dehradun, Rishkesh 249203, India
  • Meenakshi Mission Hospital and Research Centre
    Madurai, Tamil Nadu 625107, India
  • Apollo Cancer Centre
    Hyderabad, Telangana 500033, India
  • Nil Ratan Sircar Medical College and Hospital
    Kolkata, West Bengal 700014, India
  • Tata Medical Center
    Kolkata, West Bengal 700160, India
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07052006
Lead sponsor
Halia Therapeutics, Inc.
Responsible party
Sponsor
First posted
Jul 4, 2025
Start date
Dec 9, 2023
Primary completion
Jan 8, 2026
Completion
Oct 15, 2026 (estimated)
Last update
Sep 17, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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