UCAR-T_MM-XA
Clinical Study on the Safety and Tolerability of Allogeneic, Umbilical Cord Blood-derived, Dual-targeting BCMA/CD19 CAR-T Therapy for Relapsed/Refractory Multiple Myeloma
Sponsor study identifier
interventional
18
1 country
1
Study Start
October 3, 2024
Actual (reported)Primary Completion
July 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The purpose of this clinical trial is to learn if allogeneic cord blood-derived CAR-T cell drug works to treat Multiple Myeloma (MM) including Bone-related extramedullary (EMB) disease and extramedullary extraosseous disease(EME) in adults. It will also learn about the safety of the allogeneic cord blood-derived CAR-T cell drug. The main questions it aims to answer are:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 3, 2024
Actual (reported)July 20, 2025
Actual (reported)August 24, 2025
Actual (reported)July 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
the incidence rate of UCAR-T-related adverse events
Incidence of adverse events(AEs) after infusion, The number, frequency, severity, and laboratory findings of all treatment-related adverse events/serious adverse events are included. Description, time, classification, and outcome of AE events resulted from the investigational medical product, delivery method, or emergency measures will be recorded in the case report form., Up to 28 days after infusion. UCAR-T therapy-Related Adverse Events will be Assessed by CTCAE v4.0.
from lymphodepletion (D-6) through day 28 post-infusion (D+28).
The incidence rate of Dose limited toxicity (DLTs)
Dose limited toxicity(DLT) was defined as the occurrence of any of the following adverse events within 28 days of the infusion of CAR-T cells after optimal supportive treatment, which were discussed with the investigator and determined to be associated or likely to be associated with the infusion. Any DTLs within 28 days after UCAR-T infusion will be recorded in time, including severity, occurrence time, duration, treatment methods and prognosis. Specific syndromes will be graded using the following dedicated criteria: 1. Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS): 2018 American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading 2. Acute Graft-versus-Host Disease (aGvHD): MAGIC (Mount Sinai Acute GVHD International Consortium) Criteria 3. Tumor Lysis Syndrome (TLS): Cairo-Bishop Definition 4. Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis (IEC-HS): 2018 ASTCT Panel Guidelines
within 28 days after UCAR-T infusion
Overall response rate (ORR) of Multiple Myeloma (MM)
from the UCAR-T infusion to death from any cause (censored), up to 2 years.
Overall survival (OS) of MM
up to 2 years after UCAR-T cells infusion
Progression-free survival (PFS) of MM
up to 2 years after UCAR-T cells infusion
Duration of Response (DOR) of MM
up to 2 years after UCAR-T cells infusion
Quality of Life (QoL)
at Baseline, Month 1, 3, 6, 9,12, 18 and 24.
dosage form: UCAR-T cell injection Route of Administration: Single intravenous injection Participants will receive lymphodepletion with fludarabine (30 mg/m²/day) and cyclophosphamide (500 mg/m²/day) from Day -5 to -3, prior to UCAR-T cell infusion on Day 0.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Xi'an No.3 Hospital
Xi’an, Shanxi, 710016, China
Xiequn Chen, M.D.
Xi'an No.3 Hospital
First Submitted
July 20, 2025
First Posted
August 24, 2025
Study Start
October 3, 2024
Actual (reported)Primary Completion
July 30, 2028
EstimatedContact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
November 25, 2025
Record last verified: 2025-08
The IPD will be shared in a publication.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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