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
Overview
- Phase
- Not Applicable
- Intervention
- Conventional hematopoietic recovery therapy
- Conditions
- Refractory Immune Effector Cell-related Hemocytopenia
- Sponsor
- Beijing GoBroad Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- The recovery time of neutrophils
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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.
Investigators
Kai Hu
Principal Investigator
Beijing GoBroad Hospital
Eligibility Criteria
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
Arms & Interventions
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.
Intervention: Conventional hematopoietic recovery therapy
Conventional hematopoietic recovery therapy+Umbilical cord blood mononuclear cells
Umbilical cord blood mononuclear cells are obtained from umbilical cord blood by density gradient centrifugation
Intervention: Umbilical cord blood mononuclear cells
Conventional hematopoietic recovery therapy+Umbilical cord blood mononuclear cells
Umbilical cord blood mononuclear cells are obtained from umbilical cord blood by density gradient centrifugation
Intervention: Conventional hematopoietic recovery therapy
Outcomes
Primary Outcomes
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
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
- 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)