Refractory Immune Effector Cell-related Hemocytopenia
Conditions
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.
Interventions
BIOLOGICALUmbilical cord blood mononuclear cells
Intravenous infusion of UCB-MNCs (3×10\^8/ time, once a week, four times in total)
COMBINATION_PRODUCTConventional hematopoietic recovery therapy
Including but not limited to G-CSF, TPO, TPO receptor agonists, transfusions of red blood cells, platelets, etc.
Sponsors
Beijing GoBroad Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactKai Hu
Outcome results
None listed