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Clinical Trials in India / NCT07052006
Active, not recruiting Phase 2

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

NCT07052006 · tracked via the Priya Life Science India tracker
Sponsor
Halia Therapeutics, Inc.
Phase
Phase 2
Started
2023-12-09
Last updated
2026-09-17

Condition(s) studied

Myelodysplastic SyndromeAnemia in Myelodysplastic Syndromes

Investigational drug(s) / intervention(s)

HT-6184

HT-6184: Oral HT-6184

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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: 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.

Primary outcome measure(s)

Trial sites (10)

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

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07052006 on ClinicalTrials.gov ↗ ← All trials in India