New pill hopes to boost blood in bone marrow disease
NCT ID NCT07052006
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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37 people
The number who actually took part.
- Started
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Dec 2023
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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All India Institute of Medical Sciences
Dehradun, Rishkesh, 249203, India
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Apollo Cancer Centre
Hyderabad, Telangana, 500033, India
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Dr. Bafna's Star Superspeciality Clinic and Hospital
Kolhāpur, Maharashtra, 416005, India
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HCG Cancer Center Vizag
Visakhapatnam, Krishna, 530040, India
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Hemato Oncology Clinica Ahmedabad Pvt. Ltd. Vedanta Institute of Medical Sciences
Ahmedabad, Gujarat, 380009, India
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Malabar Cancer Center
Kannur, Kerala, 670103, India
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Meenakshi Mission Hospital and Research Centre
Madurai, Tamil Nadu, 625107, India
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Nil Ratan Sircar Medical College and Hospital
Kolkata, West Bengal, 700014, India
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Shalby Hospital
Ahmedabad, Gujarat, 380015, India
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Tata Medical Center
Kolkata, West Bengal, 700160, India
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