Beijing GoBroad Hospital
Beijing, Beijing Municipality, 102200, China
Not Yet Recruiting
NCT Number: NCT06729320
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
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Age ≥18 years old (including boundary values), gender is not limited
- ECOG score 0-2 points
- Expected survival ≥6 months
- 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:
- 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
- Patients who intend to undergo autologous hematopoietic stem cell transfusion or have undergone autologous hematopoietic stem cell transfusion
- Significant lack of compliance to complete the study plan (such as suffering from uncontrolled mental illness, etc.)
- Allergy or known allergy to any drug active ingredients, excipients, and blood products or preparations included in this study
- Pregnancy, breastfeeding, planning pregnancy, or unwillingness to use effective contraception as required by research
- There are other conditions that researchers believe are not suitable for inclusion
Treatment and study plan
Umbilical cord blood mononuclear cells
BiologicalIntravenous infusion of UCB-MNCs (3×10^8/ time, once a week, four times in total)
Conventional hematopoietic recovery therapy
Combination ProductIncluding but not limited to G-CSF, TPO, TPO receptor agonists, transfusions of red blood cells, platelets, etc.
Primary outcomes
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The recovery time of neutrophils
Time frame: 1 year
On the first day after discontinuing G-CSF, the neutrophil count remained above 1.0 × 10^9/L for 7 consecutive days
-
The recovery time of platelet
Time frame: 1 year
Starting from the second day of the most recent platelet transfusion, the first day of platelet count>50 × 10^9/L lasting for 7 days
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Safety of infusion
Time frame: 1 year
Acute allergies or infections related to umbilical cord blood mononuclear cell infusion, as well as shock and other infusion related reactions symptoms including but not limited to chills, fever, CRP, PCT, etc
Secondary outcomes
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Recovery of hemoglobin levels after infusion
Time frame: 1 year
Hemoglobin content in blood routine examination
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Immune function reconstruction indicators at 1, 3, 6, and 12 months after transfusion
Time frame: 1, 3, 6, and 12 months
Including but not limited to CD3, CD4, CD8, CD19, etc. in lymphoid subgroups
-
Overall survival rate
Time frame: 2 and 5 year
The proportion of participants who survived during the study period
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Beijing GoBroad Hospital
Other
Registry information
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Dec 11, 2024
- Registry last updated
- Dec 11, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.