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Clinical Trials in China / NCT06729320
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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

NCT06729320 · tracked via the Priya Life Science China tracker
Sponsor
Beijing GoBroad Hospital
Phase
Not applicable
Started
2024-12-01
Last updated
2024-12-11

Condition(s) studied

Refractory Immune Effector Cell-related Hemocytopenia

Investigational drug(s) / intervention(s)

Umbilical cord blood mononuclear cellsConventional hematopoietic recovery therapy

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.

Study summary

The purpose of this study was to evaluate the safety and efficacy of umbilical cord blood mononuclear cell in the treatment of refractory immune effector cell-related hemocytopenia by observing the efficacy related factors and adverse reactions.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥18 years old (including boundary values), gender is not limited 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: 1. Patients who intend to undergo autologous hematopoietic stem cell transfusion or have undergone autologous hematopoietic stem cell transfusion 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Beijing GoBroad Hospital Beijing Beijing Municipality

More Beijing GoBroad Hospital trials in China

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 NCT06729320 on ClinicalTrials.gov ↗ ← All trials in China