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| Name | Class |
|---|---|
| Ucello Therapeutics Co., Limited | INDUSTRY |
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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UCAR-T cells treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| allogeneic cord blood-derived, dual-targeting CD19/BCMA CAR-T cells | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| within 28 days after UCAR-T infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) of Multiple Myeloma (MM) | Anti-multiple myeloma response will be assessed according to the International Myeloma Working Group (IMWG) Uniform Response Criteria, including: Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD), Progressive Disease (PD). Overall Response Rate (ORR) =sCR+CR+VGPR+PR+MR. Assessment of ORR at month 1, 2, 3, 6, 12, 18 and 24. |
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Inclusion Criteria:
1.Aged 18 to 75 years (inclusive of boundary values), with no limitation on gender;
2.Diagnosed with multiple myeloma in accordance with the "Guidelines for the Diagnosis and Treatment of Multiple Myeloma in China (2022 Revision)" :
Bone marrow monoclonal plasma cell percentage ≥10% and/or histopathological evidence of plasmacytoma; and presence of at least one of the following SLiM CRAB features:
SLiM refers to:
CRAB refers to:
Definition of relapsed/refractory multiple myeloma:
3.Presence of at least one measurable lesion, meeting at least one of the following criteria:
4.Negative for Donor Specific Antibody (DSA);
5.The most recent assessment during the screening period indicates sufficient organ function, including renal and hepatic function, defined as:
6.Women of childbearing potential must have a negative serum pregnancy test within 7 days before enrollment. In this study, women of childbearing potential, their male partners with reproductive potential, and their partners must use effective contraception from the screening period until 12 months after UC503 administration. Women who are not of childbearing potential are defined as those who are at least 1 year postmenopausal or have documented infertility (congenital or acquired);
7.Written informed consent obtained before the initiation of any study-specific procedures.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiequn Chen, M.D. | Contact | +86 29 6130 6285 | cxq@nwu.edu.cn | |
| Qiang Zou, Ph.D. & M.D. | Contact | 86-18908237461 | zouqiang@ucellotx.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiequn Chen, M.D. | Xi'an No.3 Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xi'an No.3 Hospital | Recruiting | Xi’an | Shanxi | 710016 | China |
The IPD will be shared in a publication.
Beginning 3 months and ending 2 years after the publication of results
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| from the UCAR-T infusion to death from any cause (censored), up to 2 years. |
| Overall survival (OS) of MM | the time interval from the date of UCAR-T cells infusion to the date of death from any cause. | up to 2 years after UCAR-T cells infusion |
| Progression-free survival (PFS) of MM | The time interval from the date of UCAR-T infusion to the date of first documented disease progression per International Myeloma Working Group (IMWG) criteria, or death from any cause, whichever occurs earlier. | up to 2 years after UCAR-T cells infusion |
| Duration of Response (DOR) of MM | The time interval from the date of first documented confirmed response (≥ partial response per IMWG 2016 criteria) after UCAR-T infusion to the date of MM progression or death from any cause, whichever occurs earlier. | up to 2 years after UCAR-T cells infusion |
| Quality of Life (QoL) | Assessment using European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scale (For item1-28: max score: 112, min score: 28, higher scores mean a better outcome; for item 28-29: max score: 14, min score: 2, higher scores mean a worse outcome) to measure Quality of life at Baseline, Month 1, 3, 6, 9,12, 18 and 24. | at Baseline, Month 1, 3, 6, 9,12, 18 and 24. |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |