Myelodysplastic SyndromePhase 2NCT07052006

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

A Phase 2 study testing HT-6184 in people with Myelodysplastic Syndrome and Anemia in Myelodysplastic Syndromes, run by Halia Therapeutics, Inc. at 10 sites in India.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Myelodysplastic Syndrome, Anemia in Myelodysplastic Syndromes
What is being tested?: HT-6184
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 10 sitesIndia
Study dates: 9 Dec 2023to 15 Oct 2026
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

≥ 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).

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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.

Who cannot join

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.

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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.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

India10 sites

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

Other trials in India

About this study

Official title: A Phase 2a Study of HT-6184 in Subjects With IPSS-R Very Low, Low or Intermediate Risk Myelodysplastic Syndrome (MDS) and Symptomatic Anemia

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: Myelodysplastic Syndrome, Anemia in Myelodysplastic Syndromes
Being tested: HT-6184
Keywords: Very Low-risk MDS, Low-risk MDS, Intermediate-risk MDS, Symptomatic anemia
Medical subject headings: Myelodysplastic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HT-6184Drug
Also called Ofirnoflast
Oral HT-6184

Study groups in NCT07052006
Study group	Role	What they receive
HT-6184	Experimental	Not described Receives: Drug: HT-6184

What is being measured

The primary outcome is the main question the study is designed to answer.

The rate of hematological improvement.
Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Dec 202315 Oct 2026

First posted4 Jul 2025
Study start9 Dec 2023
Primary completion8 Jan 2026
Study completion15 Oct 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Myelodysplastic SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07052006
Sponsor's protocol ID: HT-6184-MDS-001
Other IDs: CTRI/2023/11/059758
Status last verified: Dec 2025
First submitted: 26 Jun 2025
Last updated: 17 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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