Relapsed/Refractory Multiple Myeloma(MM)Phase 1UCAR-T_MM-XANCT07139509
Allogeneic UCB-derived, Dual-targeting BCMA/CD19 CAR-T for Relapsed/Refractory Multiple Myeloma
A Phase 1 study testing allogeneic cord blood-derived, dual-targeting CD19/BCMA CAR-T cells in people with Relapsed/Refractory Multiple Myeloma(MM), run by Xi'an No.3 Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed/Refractory Multiple Myeloma(MM)
- What is being tested?
- allogeneic cord blood-derived, dual-targeting CD19/BCMA CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 3 Oct 2024to 30 Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- S: Bone marrow monoclonal plasma cell percentage ≥60%;
- Li: Ratio of involved to uninvolved serum free light chain ≥100 (with the involved light chain value being at least ≥100 mg/L);
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- M: MRI detection of >1 focal bone lesion larger than 5 mm.
- CRAB refers to:
- C: Corrected serum calcium >2.75 mmol/L [Corrected serum calcium (mmol/L) = serum total calcium (mmol/L) - 0.025×serum albumin concentration (g/L) + 1.0 (mmol/L), or corrected serum calcium (mg/dl) = serum total calcium (mg/dl) - serum albumin concentration (g/L) + 4.0 (mg/dl)];
- R: Renal insufficiency (creatinine clearance <40 ml/min or serum creatinine >177 μmol/L);
- A: Anemia (hemoglobin < lower limit of normal by 20 g/L or <100 g/L);
- B: Lytic bone lesions, demonstrated by radiographic imaging (X-ray, CT, MRI, or PET-CT) showing one or more lytic bone lesions.
- Definition of relapsed/refractory multiple myeloma:
- Must have received at least three therapeutic regimens (The induction and maintenance therapies associated with hematopoietic stem cell transplantation, whether one or both were performed, are considered as one therapeutic regimen);
- Must have been treated with a proteasome inhibitor, an immunomodulatory agent, or an anti-CD38 antibody;
- Must be refractory to the last therapeutic regimen [refractory is defined as disease progression documented during or within 60 days after completion of the last anti-multiple myeloma therapeutic regimen (based on the last dose of the drug)].
- 3.Presence of at least one measurable lesion, meeting at least one of the following criteria:
- Serum M protein ≥0.5 g/dL;
- Urine M protein ≥200 mg/24 hours;
- Serum free light chain (FLC) assay: involved FLC level ≥10 mg/dL (100 mg/L), provided that the serum FLC ratio is abnormal;
- Biopsy-proven evaluable plasmacytoma;
- Bone marrow plasma cells constituting >30% of total bone marrow cells;
- 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:
- Creatinine clearance rate ≥60 mL/min (calculated according to the Cockcroft-Gault formula);
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN (upper limit of normal);
- Total bilirubin ≤1.5×ULN (for participants with a history of Gilbert's syndrome, total bilirubin ≤2.5×ULN).
- 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.
Who cannot join
- 1.Participants meeting any of the following criteria are not eligible for enrollment in this study:
- 2.Lactating women;
- 3.Unwillingness to undergo follow-up for 15 years;
- 4.Poor compliance with the study procedures;
- 5.Individuals under legal guardianship or conservatorship;
- 6.with a history of ≥Grade 4 CRS or neurotoxicity in previous CAR-T therapy ;
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- 7.Within 5 half-lives of prior anti-MM therapies (including approved therapies and other investigational drugs) before enrollment;
- 8.Disease progression after debulking therapy;
- 9.Active central nervous system (CNS) abnormalities or history of irreversible severe CNS toxicity from prior MM treatment leading to CNS organic lesions or CNS dysfunction;
- 10.Radioimmunotherapy or radiotherapy within 8 weeks before enrollment;
- 11.Hematopoietic stem cell transplantation (HSCT) within 3 months before screening, donor lymphocyte infusion within 6 weeks before screening; patients who have undergone autologous stem cell transplantation within 100 days; patients who have undergone solid organ transplantation;
- 12.Active acute or chronic graft-versus-host disease (GvHD) requiring systemic therapy within 4 weeks before UC503 cells infusion;
- 13.Patients with autoimmune diseases who are unable to discontinue systemic immunosuppressive therapy;
- 14.Patients currently receiving or having received high-dose (total dose of 60 mg dexamethasone or equivalent other corticosteroid) systemic corticosteroid therapy within 4 weeks before lymphodepletion;
- 15.Known hypersensitivity to UCAR-T or any of its components;
- 16.Any known uncontrolled cardiovascular disease within 6 months before enrollment, or any of the following conditions: ≥Grade 2 ventricular or atrial arrhythmias, ≥Grade 2 bradycardia, myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, poorly controlled hypertension with standard medications. Or left ventricular ejection fraction (LVEF) < 45% as assessed by echocardiogram or multigated acquisition scan (MUGA) at screening;
- 17.Any known uncontrolled pulmonary disease within 6 months before enrollment, or any of the following conditions: pulmonary embolism, chronic obstructive pulmonary disease, history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonia, idiopathic pneumonia, or evidence of active pneumonia on chest CT scan at screening. A history of radiation pneumonitis/fibrosis within the radiation field is allowed, as well as symptomatic or poorly controlled interstitial lung disease, clinically significant pulmonary function abnormalities;
- 18.History of hypertensive crisis or hypertensive encephalopathy within 3 months before screening;
- 19.At enrollment, active bacterial, fungal, protozoal, or viral infections that are not effectively controlled despite adequate treatment, and positive blood cultures within 7 days before enrollment;
- 20.Undergone any major surgery within 3 months before screening;
- 21.Received any live-attenuated vaccine within 4 weeks before screening;
- 22.Any abnormal findings, medical conditions, or laboratory test results during the screening period that the investigator deems may jeopardize patient safety;
- 23.Any planned medical or surgical treatment that may interfere with the normal conduct of the study;
- 24.Presence of another malignancy within 2 years before screening (excluding in situ basal or squamous cervical cancer or cutaneous basal cell carcinoma);
- 25.Patient's psychiatric condition that prevents understanding of the nature, scope, and potential consequences of the study, and/or unwillingness to cooperate;
- 26.At enrollment, positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal range; positive for hepatitis C virus (HCV) antibody with peripheral blood HCV RNA titer greater than the normal range; positive for human immunodeficiency virus (HIV) antibody; positive for human T-cell leukemia virus (HTLV) antibody; positive for Treponema pallidum antibody; positive for cytomegalovirus (CMV) DNA;
- 27.Contraindications to any drugs that may be used, including lymphodepleting agents such as fludarabine and cyclophosphamide, or agents maybe used for managing adverse events such as tocilizumab.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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:
- What adverse events occur and the incidence rate of DLTs within 28 days and UCAR-T-related AEs within 28 days after the allogeneic cord blood-derived CAR-T cell injection for multiple myeloma (MM)?
- Which dose level is the optimal biological dose (OBD)?
- What is the overall responserate (ORR), including stringent complete response (sCR), completeresponse (CR),very good partial response (VGPR), partial response (PR), minimal Response (MR) and DOR, PFS, RFS, OS?
Read more
Participants will:
- be pretreated with FC regimen, fludarabine (30mg/m²/d, days -5, -4, and -3) and cyclophosphamide (300~500 mg/m²/d, day -5,-4, and -3).
- rest for 2 days on Day-2 and Day-1. Tumor burden should be re-evaluated and chemotherapy side effects assessment.
- receive allogeneic cord blood-derived CAR-T cells infusion
- Visit the clinic at D28, 1 month, 2 months, 3 months, 4 months, 6 months, 9 months and 1 year after CAR-T cells infusion.
- Conditions
- Relapsed/Refractory Multiple Myeloma(MM)
- Being tested
- allogeneic cord blood-derived, dual-targeting CD19/BCMA CAR-T cells
- Keywords
- allogeneic CAR-T, umbilical cord blood-derived, relapsed/refractory multiple myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allogeneic cord blood-derived, dual-targeting CD19/BCMA CAR-T cellsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| UCAR-T cells treatment | Experimental | Not described Receives: Drug: allogeneic cord blood-derived, dual-targeting CD19/BCMA CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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:
- Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS): 2018 American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading
- Acute Graft-versus-Host Disease (aGvHD): MAGIC (Mount Sinai Acute GVHD International Consortium) Criteria
- Tumor Lysis Syndrome (TLS): Cairo-Bishop Definition
- Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis (IEC-HS): 2018 ASTCT Panel Guidelines
Measured: within 28 days after UCAR-T infusion
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at Baseline, Month 1, 3, 6, 9,12, 18 and 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start3 Oct 2024
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Multiple Myeloma(MM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xi'an No.3 Hospital
- Sponsor type
- Other government
- Collaborators
- Ucello Therapeutics Co., Limited
- Responsible party
- Principal investigator, XieQun CHEN, Xi'an No.3 Hospital
- Investigators
- Xiequn Chen, M.D., Principal investigator, Xi'an No.3 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139509
- Sponsor's protocol ID
- UC-MM-2024-02
- Acronym
- UCAR-T_MM-XA
- Status last verified
- Aug 2025
- First submitted
- 20 Jul 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD will be shared in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07139509
- Acronym / sponsor ID
- UCAR-T_MM-XA / UC-MM-2024-02
- Conditions
- Relapsed/Refractory Multiple Myeloma(MM)
- Keywords
- allogeneic CAR-T, umbilical cord blood-derived, relapsed/refractory multiple myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Xi'an No.3 HospitalOther government
- Collaborators
- Ucello Therapeutics Co., Limited
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What adverse events occur and the incidence rate of DLTs within 28 days and UCAR-T-related AEs within 28 days after the allogeneic cord blood-derived CAR-T cell injection for multiple myeloma (MM)?
- Which dose level is the optimal biological dose (OBD)?
- What is the overall responserate (ORR), including stringent complete response (sCR), completeresponse (CR),very good partial response (VGPR), partial response (PR), minimal Response (MR) and DOR, PFS, RFS, OS?
Participants will:
- be pretreated with FC regimen, fludarabine (30mg/m²/d, days -5, -4, and -3) and cyclophosphamide (300~500 mg/m²/d, day -5,-4, and -3).
- rest for 2 days on Day-2 and Day-1. Tumor burden should be re-evaluated and chemotherapy side effects assessment.
- receive allogeneic cord blood-derived CAR-T cells infusion
- Visit the clinic at D28, 1 month, 2 months, 3 months, 4 months, 6 months, 9 months and 1 year after CAR-T cells infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UCAR-T cells treatment | Experimental | Drug: allogeneic cord blood-derived, dual-targeting CD19/BCMA CAR-T cells |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- 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)" :
- 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:
Key exclusion criteria (27 listed)
- 1.Participants meeting any of the following criteria are not eligible for enrollment in this study:
- 2.Lactating women;
- 3.Unwillingness to undergo follow-up for 15 years;
- 4.Poor compliance with the study procedures;
- 5.Individuals under legal guardianship or conservatorship;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| allogeneic cord blood-derived, dual-targeting CD19/BCMA CAR-T cellsdosage 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. | Drug | UCAR-T cells treatment |
Primary outcome
the incidence rate of UCAR-T-related adverse events
Time frame: from lymphodepletion (D-6) through day 28 post-infusion (D+28).
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.
The incidence rate of Dose limited toxicity (DLTs)
Time frame: within 28 days after UCAR-T infusion
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
5 secondary outcomes
Overall response rate (ORR) of Multiple Myeloma (MM)
Time frame: from the UCAR-T infusion to death from any cause (censored), up to 2 years.
Overall survival (OS) of MM
Time frame: up to 2 years after UCAR-T cells infusion
Progression-free survival (PFS) of MM
Time frame: up to 2 years after UCAR-T cells infusion
Duration of Response (DOR) of MM
Time frame: up to 2 years after UCAR-T cells infusion
Quality of Life (QoL)
Time frame: at Baseline, Month 1, 3, 6, 9,12, 18 and 24.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: Yes. The IPD will be shared in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiequn Chen, M.D. principal investigator
Xi'an No.3 Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing allogeneic cord blood-derived, dual-targeting CD19/BCMA CAR-T cells in people with Relapsed/Refractory Multiple Myeloma(MM), run by Xi'an No.3 Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiequn Chen, M.D. (+86 29 6130 6285, cxq@nwu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence rate of UCAR-T-related adverse events (time frame: from lymphodepletion (D-6) through day 28 post-infusion (D+28).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025; AzTrials last refreshed its copy on 26 Oct 2026.