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 | Not Yet Recruiting DMC

• 1 other identifier: UCB-MNCs-2024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractory Immune Effector Cell-related Hemocytopenia

Outcome Measures

Primary Outcomes (3)

• The recovery time of neutrophils

  On the first day after discontinuing G-CSF, the neutrophil count remained above 1.0 × 10\^9/L for 7 consecutive days

  1 year

• The recovery time of platelet

  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

  1 year

• Safety of infusion

  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

  1 year

Secondary Outcomes (3)

• Recovery of hemoglobin levels after infusion

  1 year

• Immune function reconstruction indicators at 1, 3, 6, and 12 months after transfusion

  1, 3, 6, and 12 months

• Overall survival rate

  2 and 5 year

Study Arms (2)

Conventional hematopoietic recovery therapy

ACTIVE COMPARATOR

Conventional hematopoietic recovery therapy including but not limited to G-CSF, TPO, TPO receptor agonists, transfusions of red blood cells, platelets, etc.

Combination Product: Conventional hematopoietic recovery therapy

Conventional hematopoietic recovery therapy+Umbilical cord blood mononuclear cells

EXPERIMENTAL

Umbilical cord blood mononuclear cells are obtained from umbilical cord blood by density gradient centrifugation

Biological: Umbilical cord blood mononuclear cells; Combination Product: Conventional hematopoietic recovery therapy

Interventions

Umbilical cord blood mononuclear cells BIOLOGICAL

Intravenous infusion of UCB-MNCs (3×10\^8/ time, once a week, four times in total)

Conventional hematopoietic recovery therapy+Umbilical cord blood mononuclear cells

Conventional hematopoietic recovery therapy COMBINATION_PRODUCT

Including but not limited to G-CSF, TPO, TPO receptor agonists, transfusions of red blood cells, platelets, etc.

Conventional hematopoietic recovery therapy; Conventional hematopoietic recovery therapy+Umbilical cord blood mononuclear cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing GoBroad Hospital: lead

Study Sites (1)

Beijing GoBroad Hospital

Beijing, Beijing Municipality, 102200, China

Location

Central Study Contacts

Kai Hu

CONTACT

+86 150 1039 0336; huk@gobroadhealthcare.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: December 11, 2024
• Study Start: December 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)