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Recruiting EARLY_Phase 1 NCT07212335

Safety and Efficacy of Umbilical Cord Blood-Derived Mesenchymal Stem Cells in the Treatment of Long-Term Cytopenia After CAR-T Therapy

Trial Parameters

Condition Immune Effector Cell Associated Hematotoxicity
Sponsor Institute of Hematology & Blood Diseases Hospital, China
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 15
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-10-01
Completion 2027-09-30
Interventions
Mesenchymal Stem Cell Infusion

Brief Summary

This study is a single arm, open label, exploratory clinical study aimed at evaluating the efficacy, and safety of allogeneic umbilical cord blood-derived mesenchymal stem cells in the treatment of long-term cytopenia after CAR-T therapy.

Eligibility Criteria

Inclusion Criteria Patients must meet all the following criteria to be enrolled in this study: * 1.Voluntarily participate in the study and sign the informed consent form; * 2.Aged ≥ 18 years, regardless of gender; * 3.Patients with acute lymphoblastic leukemia (ALL), lymphoma, or myeloma who still have severe cytopenia (meeting any of the following conditions: absolute neutrophil count ≤ 1×10⁹/L; platelet count ≤ 30×10⁹/L; hemoglobin ≤ 70 g/dL) 3 weeks after CAR-T cell infusion; * 4.ECOG performance status score ≤ 2; * 5.Estimated survival time ≥ 6 months; * 6.For female patients of childbearing potential, a negative pregnancy test result is required. Female patients of childbearing potential and male patients must use highly effective contraceptive measures during the study period and for 4 months/6 months after the discontinuation of treatment, respectively. Exclusion Criteria Patients with any of the following conditions are prohibited from enrolling in this study: * 1.Having recei

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