New pill hopes to boost blood in bone marrow disease

NCT ID NCT07052006

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 2 times

Summary

This study tests an experimental drug, HT-6184, in adults with a bone marrow disorder called myelodysplastic syndrome (MDS) who have low red blood cell counts (anemia). The goal is to see if the drug can improve blood counts and reduce the need for transfusions. Participants take the drug for up to 32 weeks and are monitored for safety and response.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

37 people

The number who actually took part.

Started

Dec 2023

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: 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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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • All India Institute of Medical Sciences

    Dehradun, Rishkesh, 249203, India

  • Apollo Cancer Centre

    Hyderabad, Telangana, 500033, India

  • Dr. Bafna's Star Superspeciality Clinic and Hospital

    Kolhāpur, Maharashtra, 416005, India

  • HCG Cancer Center Vizag

    Visakhapatnam, Krishna, 530040, India

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

    Ahmedabad, Gujarat, 380009, India

  • Malabar Cancer Center

    Kannur, Kerala, 670103, India

  • Meenakshi Mission Hospital and Research Centre

    Madurai, Tamil Nadu, 625107, India

  • Nil Ratan Sircar Medical College and Hospital

    Kolkata, West Bengal, 700014, India

  • Shalby Hospital

    Ahmedabad, Gujarat, 380015, India

  • Tata Medical Center

    Kolkata, West Bengal, 700160, India

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