A Randomized Controlled, Open, Single-center Clinical Study Evaluating the Efficacy and Safety of Umbilical Cord Blood Mononuclear Cells in Patients with Refractory Immune Effector Cell-related Hemocytopenia
NCT ID: NCT06729320
Last Updated: 2024-12-11
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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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2024-12-01
2025-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conventional hematopoietic recovery therapy
Conventional hematopoietic recovery therapy including but not limited to G-CSF, TPO, TPO receptor agonists, transfusions of red blood cells, platelets, etc.
Conventional hematopoietic recovery therapy
Including but not limited to G-CSF, TPO, TPO receptor agonists, transfusions of red blood cells, platelets, etc.
Conventional hematopoietic recovery therapy+Umbilical cord blood mononuclear cells
Umbilical cord blood mononuclear cells are obtained from umbilical cord blood by density gradient centrifugation
Umbilical cord blood mononuclear cells
Intravenous infusion of UCB-MNCs (3×10\^8/ time, once a week, four times in total)
Conventional hematopoietic recovery therapy
Including but not limited to G-CSF, TPO, TPO receptor agonists, transfusions of red blood cells, platelets, etc.
Interventions
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Umbilical cord blood mononuclear cells
Intravenous infusion of UCB-MNCs (3×10\^8/ time, once a week, four times in total)
Conventional hematopoietic recovery therapy
Including but not limited to G-CSF, TPO, TPO receptor agonists, transfusions of red blood cells, platelets, etc.
Eligibility Criteria
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Inclusion Criteria
2. ECOG score 0-2 points
3. Expected survival ≥6 months
4. Patients who have received immune effector cell therapy (marketed CAR-T cell therapy or dual antibody therapy) (no target), have grade 3-4 hemocytopenia after treatment, and do not recover to grade 2 within 3 weeks after conventional treatment. Defined as follows:
1\) The neutrophils again decreased to grade ≥3 within 1 week after G-CSF discontinuation, or 2) Unable to detach from red blood cell or platelet transfusion (infusion time less than one week requires re-infusion) (5) Understand the research protocol and sign the informed consent voluntarily
Exclusion Criteria
2. Significant lack of compliance to complete the study plan (such as suffering from uncontrolled mental illness, etc.)
3. Allergy or known allergy to any drug active ingredients, excipients, and blood products or preparations included in this study
4. Pregnancy, breastfeeding, planning pregnancy, or unwillingness to use effective contraception as required by research
5. There are other conditions that researchers believe are not suitable for inclusion
18 Years
ALL
No
Sponsors
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Beijing GoBroad Hospital
OTHER
Responsible Party
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Kai Hu
Principal Investigator
Locations
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Beijing GoBroad Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Kai Hu
Role: primary
Other Identifiers
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UCB-MNCs-2024
Identifier Type: -
Identifier Source: org_study_id