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

Not Applicable

Not yet recruiting

• Conditions: Refractory Immune Effector Cell-related Hemocytopenia
• Interventions: Combination Product: Conventional hematopoietic recovery therapy; Biological: Umbilical cord blood mononuclear cells

• Registration Number: NCT06729320
• Lead Sponsor: Beijing GoBroad Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-01
• Study First Submitted: 2024-12-08
• Study First Submitted QC: 2024-12-08
• Last Update Submitted: 2024-12-08
• Study First Posted: 2024-12-11
• Last Update Posted: 2024-12-11
• Primary Completion: 2025-06-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional hematopoietic recovery therapy	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+Umbilical cord blood mononuclear cells	Umbilical cord blood mononuclear cells	Umbilical cord blood mononuclear cells are obtained from umbilical cord blood by density gradient centrifugation
Conventional hematopoietic recovery therapy+Umbilical cord blood mononuclear cells	Conventional hematopoietic recovery therapy	Umbilical cord blood mononuclear cells are obtained from umbilical cord blood by density gradient centrifugation

Primary Outcome Measures

Name	Time	Method
The recovery time of neutrophils	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	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
Safety of infusion	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 Outcome Measures

Name	Time	Method
Recovery of hemoglobin levels after infusion	1 year	Hemoglobin content in blood routine examination
Immune function reconstruction indicators at 1, 3, 6, and 12 months after transfusion	1, 3, 6, and 12 months	Including but not limited to CD3, CD4, CD8, CD19, etc. in lymphoid subgroups
Overall survival rate	2 and 5 year	The proportion of participants who survived during the study period

Trial Locations

Locations (1)

Beijing GoBroad Hospital; 🇨🇳 Beijing, Beijing, China