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MPN Clinical Trial Finder

Clinical Trial Finder

Search Results

Study of BC3402 in Combination With Azacitidine in Patients With MDS and CMML

Study Purpose

The study is to evaluate safety, pharmacokinetics, pharmacodynamics and efficacy of BC3402 in combination with azacitidine (AZA) in subjects with Myelodysplastic Syndrome (MDS) and Chronic myelomonocytic leukemia (CMML)

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. MDS and CMML subjects with higher risk; 2. Age ≥ 18 years old; 3. Eastern Cooperative Oncology Group score of 0~2; 4. Not suitable for or refuse to receive hematopoietic stem cell transplant(HSCT); 5. Subjects should take effective contraceptive measures. 6. Must sign the Informed Consent Form (ICF), and be able to follow all study procedures.

Exclusion Criteria:

1. Prior exposure to anti-TIM-3 therapy at any time. 2. Previous HSCT. 3. Live vaccine administered within 4 weeks prior to start of treatment. 4. Current use or use within 7 days prior to start of treatment of systemic steroid therapy (> 10 mg/day prednisone or equivalent) or any immunosuppressive therapy. Topical, inhaled, nasal, ophthalmic steroids are allowed. Other protocol-defined Inclusion/Exclusion may apply.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05970822
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Biocity Biopharmaceutics Co., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Zhijian Xiao, MD
Principal Investigator Affiliation Institute of Hematology & Blood Diseases Hospital,Chinese Academy of Medical Sciences
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia
Arms & Interventions

Arms

Experimental: BC3402+azacitidine

Subjects will receive azacitidine and BC3402 in a treatment cycle.

Interventions

Drug: - BC3402

Escalating of BC3402 will be administered IV(intravenous)

Drug: - Azacitidine

Azacitidine will be administered daily

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Tianjin, Tianjin, China

Status

Recruiting

Address

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin, 300011

Site Contact

Zhijian Xiao, MD

[email protected]

+86 13821085716

Nearest Location

Site Contact

Zhijian Xiao, MD

[email protected]

+86 13821085716

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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