A Phase 2a Study of HT-6184 in Subjects With IPSS-R Very Low, Low or Intermediate Risk MDS and Anemia
NCT ID: NCT07052006
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
37 participants
INTERVENTIONAL
2023-12-09
2026-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HT-6184
HT-6184
Oral HT-6184
Interventions
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HT-6184
Oral HT-6184
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Halia Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Hemato Oncology Clinica Ahmedabad Pvt. Ltd. Vedanta Institute of Medical Sciences
Ahmedabad, Gujarat, India
Shalby Hospital
Ahmedabad, Gujarat, India
Malabar Cancer Center
Kannur, Kerala, India
HCG Cancer Center Vizag
Visakhapatnam, Krishna, India
Dr. Bafna's Star Superspeciality Clinic and Hospital
Kolhāpur, Maharashtra, India
All India Institute of Medical Sciences
Dehradun, Rishkesh, India
Meenakshi Mission Hospital and Research Centre
Madurai, Tamil Nadu, India
Apollo Cancer Centre
Hyderabad, Telangana, India
Nil Ratan Sircar Medical College and Hospital
Kolkata, West Bengal, India
Tata Medical Center
Kolkata, West Bengal, India
Countries
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Other Identifiers
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CTRI/2023/11/059758
Identifier Type: OTHER
Identifier Source: secondary_id
HT-6184-MDS-001
Identifier Type: -
Identifier Source: org_study_id