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

Beijing GoBroad Hospital

Status: Not yet enrolling

Conditions: Refractory Immune Effector Cell-related Hemocytopenia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06729320

UCB-MNCs-2024

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Conventional hematopoietic recovery therapy

Active Comparator group

Description:

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

Treatment:

Combination Product: Conventional hematopoietic recovery therapy

Conventional hematopoietic recovery therapy+Umbilical cord blood mononuclear cells

Experimental group

Description:

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

Treatment:

Combination Product: Conventional hematopoietic recovery therapy

Biological: Umbilical cord blood mononuclear cells