Acute Myeloid LeukaemiaPhase 1/2NCT07036250
Clinical Study of U32 in Patients With Acute Myeloid Leukemia
A Phase 1/2 study testing U32 CAR-T in people with Acute Myeloid Leukaemia, run by Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd at 1 site in China.
Trial summary
This is a single-arm, open-label clinical study to evaluate the safety, tolerability, and efficacy of U32 injection in patients with acute myeloid leukemia. Read more about this study
- Who is it for?
- Ages 2 to 65 years
- Conditions the study is for
- Acute Myeloid Leukaemia
- What is being tested?
- U32 CAR-T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 3 Jul 2025to 31 Dec 2029
- Phase
- Phase 1/2
- 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 2 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Voluntarily sign the informed consent form and be expected to complete the follow-up examinations and treatments as required by the study protocol.
- Be aged ≥2 years and ≤65 years at the time of signing the informed consent form, with no restrictions on gender.
- Meet the AML diagnosis according to the 2022 WHO classification and satisfy the diagnostic criteria for relapsed and refractory acute myeloid leukemia as defined in the "Chinese Guidelines for the Diagnosis and Treatment of Relapsed and Refractory Acute Myeloid Leukemia (2023 Edition)": a) Relapsed AML diagnostic criteria: reappearance of leukemia cells in peripheral blood after complete remission (CR), or positivity for minimal residual disease (MRD) detected by flow cytometry in bone marrow (excluding other causes such as bone marrow regeneration after consolidation chemotherapy), or extramedullary infiltration of leukemia cells. b) Refractory AML diagnostic criteria: newly diagnosed cases that are ineffective after two courses of standard treatment; relapse within 12 months after CR and subsequent consolidation therapy; relapse after 12 months that is ineffective to conventional chemotherapy; cases with two or more relapses; persistent extramedullary leukemia.
- AML patients who are molecularly positive after treatment and cannot achieve negativity through conventional therapy.
- Positive expression of CD38 or CLL-1 confirmed by immunohistochemistry or flow cytometry.
- Have previously received at least two lines of adequate treatment or allogeneic hematopoietic stem cell transplantation (HSCT).
Show all 13Show fewer
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 3, with an expected survival of more than 3 months.
- Have adequate bone marrow reserve at screening, defined as: absolute lymphocyte count (ALC) ≥0.3×10^9/L, platelets (PLT) ≥20×10^9/L (including with platelet transfusion support).
- Have appropriate organ function: aspartate aminotransferase (AST) ≤3 times the upper limit of normal (ULN); alanine aminotransferase (ALT) ≤3 times ULN; total bilirubin ≤1.5 times ULN; serum creatinine ≤1.5 times ULN, or creatinine clearance rate ≥60 mL/min; hemoglobin ≥60 g/L or maintained at this level after transfusion; peripheral capillary oxygen saturation ≥92%; left ventricular ejection fraction (LVEF) ≥45%.
- Female subjects must meet the following criteria to be considered for enrollment: a) Be of non-childbearing potential, defined as: having undergone hysterectomy or bilateral oophorectomy, or having had bilateral tubal ligation, or being postmenopausal (complete cessation of menstruation for ≥1 year); b) Be of childbearing potential, but have a negative serum pregnancy test at screening, and agree to use medically accepted contraceptive measures (such as intrauterine device, oral contraceptives, or condoms) before enrollment and during the study, until 1 year after the last study drug administration.
- Male subjects of childbearing potential must agree to use barrier contraception or complete abstinence until 1 year after the last study drug administration.
- Have sufficient venous access for apheresis or intravenous blood draw, and no contraindications for leukapheresis.
- For subjects who have received daratumumab or other CD38 - targeted therapies, the washout period for CD38 monoclonal antibody should be at least 3 months before the reinfusion treatment.
Who cannot join
- Having other malignancies within 3 years prior to screening, with the exception of adequately treated cervical carcinoma in situ, papillary thyroid carcinoma, basal cell carcinoma or squamous cell carcinoma of the skin, localized prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery.
- Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), with detectable HBV-DNA levels above the lower limit of detection in peripheral blood; positive for hepatitis C virus (HCV) antibodies with detectable HCV-RNA levels above the lower limit of detection; positive for human immunodeficiency virus (HIV) antibodies; positive for cytomegalovirus (CMV) DNA; positive for EBV-DNA; positive for syphilis serology.
- A history of severe allergic reactions [defined as allergic reactions of grade 2 or higher, with any of the following clinical manifestations: airway obstruction (rhinorrhea, cough, wheezing, dyspnea), tachycardia, hypotension, arrhythmia, gastrointestinal symptoms (nausea, vomiting), urinary or fecal incontinence, laryngeal edema, bronchial spasm, cyanosis, shock, respiratory or cardiac arrest] or known allergy to any active ingredient, excipient, or murine product or xenoprotein contained in the study drug (including the lymphodepletion regimen).
- Severe cardiac disease, including but not limited to severe arrhythmias, unstable angina, large myocardial infarction, New York Heart Association (NYHA) Class III or IV heart failure, refractory hypertension (defined as failure to achieve target blood pressure despite the use of a reasonable and tolerable regimen of ≥3 antihypertensive medications [including diuretics] for >1 month or requiring ≥4 antihypertensive medications for effective blood pressure control).
- History of solid organ transplant or planned solid organ transplant (excluding allogeneic hematopoietic stem cell transplant).
- Acute or chronic graft-versus-host disease (GVHD) that is deemed uncontrollable by the investigator.
Show all 17Show fewer
- Allogeneic hematopoietic stem cell transplant within 6 months prior to screening.
- Active autoimmune or inflammatory disease (e.g., Guillain-Barré syndrome [GBS], amyotrophic lateral sclerosis [ALS]) or clinically significant active cerebrovascular disease (e.g., cerebral edema, posterior reversible encephalopathy syndrome [PRES]).
- Presence of a tumor emergency (e.g., spinal cord compression, bowel obstruction, leukostasis, tumor lysis syndrome) requiring urgent treatment prior to screening or infusion.
- Presence of uncontrollable bacterial, fungal, viral, or other infections requiring antibiotic therapy.
- Planned to undergo major surgery within 4 weeks prior to lymphodepletion or during the study period, or surgical wounds not fully healed prior to enrollment.
- Presence of severe psychiatric disorders.
- Within 1 week prior to planned PBMC collection, receiving systemic corticosteroids or immunosuppressive agents that are deemed by the investigator to affect cell preparation. a) Systemic corticosteroids: subjects receiving systemic corticosteroid therapy within 1 week prior to planned PBMC collection and deemed by the investigator to require long-term systemic corticosteroid therapy during the treatment period (excluding inhaled or topical use); b) Immunosuppressive agents: subjects receiving immunosuppressive agents within 1 week prior to planned PBMC collection.
- Received live-attenuated or live virus vaccines within 4 weeks prior to screening.
- History of alcoholism or drug abuse.
- Participation in another interventional clinical trial within 30 days prior to screening.
- Any subject deemed by the investigator, based on clinical judgment or standards of care, to have a contraindication to any study procedure or other medical conditions that may pose an unacceptable risk.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University, Suzhou, JiangSu 215000 Recruiting
Suzhou, 215000
Xiaowen Tang, Ph.D.
About this study
Official title: A Single-arm, Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of U32 Injection in Patients With Acute Myeloid Leukemia.
This is a single-arm, open-label clinical study to evaluate the safety, tolerability, and efficacy of U32 injection in patients with acute myeloid leukemia.
Read the detailed description
The primary objective of this study is to evaluate the safety and tolerability of U32 in the treatment of acute myeloid leukemia and to determine the safe and effective dosage.
- Conditions
- Acute Myeloid Leukaemia
- Being tested
- U32 CAR-T
- Keywords
- CAR-T, CD38, CLL-1
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
U32 CAR-TDrug
Lymphodepletion preconditioning is required prior to CAR-T cell therapy. Lymphodepletion will be performed using a regimen of cyclophosphamide (250-500 mg/m²) and fludarabine (25-30 mg/m²), each administered for 3 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| U32 CAR-T cells | Experimental | The Patients will be enrolled into 3 dose level cohorts Receives: Drug: U32 CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse events after U32CAR-T cells infusion [Safety and Tolerability]
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Measured: 28 days post administration of CAR-T-cells
Secondary outcomes (8)
Pharmacokinetics of U32 CAR-T cells
Time at the maximal concentration(Tmax)
Measured: 2 years post CAR T cell infusion
Pharmacokinetics of U32 CAR-T cells
Area under the concentration-time curve(AUC)
Measured: 2 years post CAR T cell infusion
Pharmacokinetics of U32 CAR-T cells
The maximal concentration of eripheral blood (Cmax)
Measured: 2 years post CAR T cell infusion
Pharmacodynamics of U32 CAR-T cells
Concentration levels of CAR-T-related serum cytokines such as IL-6, IFN γ, ferritin and CRP at each time point
Measured: 2 years post CAR T cell infusion
Objective Response Rate (ORR), as assessed by Investigators
The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Remission (CR) or CR with partial hematologic recovery (CRh) or CR with incomplete hematologic recovery (CRi)
Measured: 2 years post CAR T cell infusion
Duration of response (DOR), as assessed by Investigators
Duration of response (DOR) is defined as the time from the first documented objective response to the first documented disease progression or death.
Measured: 2 years post CAR T cell infusion
Overall survival (OS)
Overall Survival (OS) was defined as the time from the date of first infusion of U32 to the date of death due to any cause.
Measured: 2 years post CAR T cell infusion
Progression-free survival (PFS), as assessed by Investigators
Progression-free survival (PFS) was defined as the time from the date of infusion to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause.
Measured: 2 years post CAR T cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start3 Jul 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukaemiaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaowen Tang, Ph.D., Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036250
- Sponsor's protocol ID
- U32-03
- Status last verified
- Jun 2025
- First submitted
- 27 May 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of U32 Injection in Patients With Acute Myeloid Leukemia.
- ClinicalTrials.gov ID
- NCT07036250
- Acronym / sponsor ID
- U32-03
- Conditions
- Acute Myeloid Leukaemia
- Keywords
- CAR-T, CD38, CLL-1
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai Unicar-Therapy Bio-medicine Technology Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 25 Jun 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.
This is a single-arm, open-label clinical study to evaluate the safety, tolerability, and efficacy of U32 injection in patients with acute myeloid leukemia.
Detailed description
The primary objective of this study is to evaluate the safety and tolerability of U32 in the treatment of acute myeloid leukemia and to determine the safe and effective dosage.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| U32 CAR-T cells | Experimental | Drug: U32 CAR-TThe Patients will be enrolled into 3 dose level cohorts |
Who may qualify
- Ages
- 2 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Voluntarily sign the informed consent form and be expected to complete the follow-up examinations and treatments as required by the study protocol.
- Be aged ≥2 years and ≤65 years at the time of signing the informed consent form, with no restrictions on gender.
- Meet the AML diagnosis according to the 2022 WHO classification and satisfy the diagnostic criteria for relapsed and refractory acute myeloid leukemia as defined in the "Chinese Guidelines for the Diagnosis and Treatment of Relapsed and Refractory Acute Myeloid Leukemia (2023 Edition)": a) Relapsed AML diagnostic criteria: reappearance of leukemia cells in peripheral blood after complete remission (CR), or positivity for minimal residual disease (MRD) detected by flow cytometry in bone marrow (excluding other causes such as bone marrow regeneration after consolidation chemotherapy), or extramedullary infiltration of leukemia cells. b) Refractory AML diagnostic criteria: newly diagnosed cases that are ineffective after two courses of standard treatment; relapse within 12 months after CR and subsequent consolidation therapy; relapse after 12 months that is ineffective to conventional chemotherapy; cases with two or more relapses; persistent extramedullary leukemia.
- AML patients who are molecularly positive after treatment and cannot achieve negativity through conventional therapy.
- Positive expression of CD38 or CLL-1 confirmed by immunohistochemistry or flow cytometry.
Key exclusion criteria (17 listed)
- Having other malignancies within 3 years prior to screening, with the exception of adequately treated cervical carcinoma in situ, papillary thyroid carcinoma, basal cell carcinoma or squamous cell carcinoma of the skin, localized prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery.
- Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), with detectable HBV-DNA levels above the lower limit of detection in peripheral blood; positive for hepatitis C virus (HCV) antibodies with detectable HCV-RNA levels above the lower limit of detection; positive for human immunodeficiency virus (HIV) antibodies; positive for cytomegalovirus (CMV) DNA; positive for EBV-DNA; positive for syphilis serology.
- A history of severe allergic reactions [defined as allergic reactions of grade 2 or higher, with any of the following clinical manifestations: airway obstruction (rhinorrhea, cough, wheezing, dyspnea), tachycardia, hypotension, arrhythmia, gastrointestinal symptoms (nausea, vomiting), urinary or fecal incontinence, laryngeal edema, bronchial spasm, cyanosis, shock, respiratory or cardiac arrest] or known allergy to any active ingredient, excipient, or murine product or xenoprotein contained in the study drug (including the lymphodepletion regimen).
- Severe cardiac disease, including but not limited to severe arrhythmias, unstable angina, large myocardial infarction, New York Heart Association (NYHA) Class III or IV heart failure, refractory hypertension (defined as failure to achieve target blood pressure despite the use of a reasonable and tolerable regimen of ≥3 antihypertensive medications [including diuretics] for >1 month or requiring ≥4 antihypertensive medications for effective blood pressure control).
- History of solid organ transplant or planned solid organ transplant (excluding allogeneic hematopoietic stem cell transplant).
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 |
|---|---|---|
| U32 CAR-TLymphodepletion preconditioning is required prior to CAR-T cell therapy. Lymphodepletion will be performed using a regimen of cyclophosphamide (250-500 mg/m²) and fludarabine (25-30 mg/m²), each administered for 3 consecutive days. | Drug | U32 CAR-T cells |
Primary outcome
Incidence of Adverse events after U32CAR-T cells infusion [Safety and Tolerability]
Time frame: 28 days post administration of CAR-T-cells
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
8 secondary outcomes
Pharmacokinetics of U32 CAR-T cells
Time frame: 2 years post CAR T cell infusion
Pharmacokinetics of U32 CAR-T cells
Time frame: 2 years post CAR T cell infusion
Pharmacokinetics of U32 CAR-T cells
Time frame: 2 years post CAR T cell infusion
Pharmacodynamics of U32 CAR-T cells
Time frame: 2 years post CAR T cell infusion
Objective Response Rate (ORR), as assessed by Investigators
Time frame: 2 years post CAR T cell infusion
Duration of response (DOR), as assessed by Investigators
Time frame: 2 years post CAR T cell infusion
Overall survival (OS)
Time frame: 2 years post CAR T cell infusion
Progression-free survival (PFS), as assessed by Investigators
Time frame: 2 years post CAR T cell infusion
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 Jun 2025.
Related trials for Acute Myeloid Leukaemia
RecruitingPhase 1/2
Study of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants With Advanced Haematologic Malignancies With KMT2Ar, NPM1m, or Other Genotypes Associated With HOX Overexpression
Acute Lymphoblastic Leukaemia, Acute Myeloid Leukaemia
RecruitingPhase 1
Phase 1 Open-label Study of AMX-883 Alone in Participants With AML and High-risk MDS and in Combination in Participants With AML
Acute Myeloid Leukaemia, High Risk Myelodysplastic Syndrome
Active, not recruiting
Biomarkers in Patients With Anemia-Induced Thrombocytopenic Bleeding
Acute Leukemia, Acute Myeloid Leukemia (AML)
RecruitingObservational study
A Longitudinal Multi-Center Molecular Biomarker Discovery Registry for Patients With Hematologic Malignancies
Acute Myeloid Leukaemia (AML), Follicular Lymphoma ( FL)
Not yet recruitingPhase 2
Phase II De-Escalation Study of Metronomic Decitabine/Cedazuridine Plus Venetoclax in AML
Acute Myeloid Leukaemia (AML)
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.
Xiaowen Tang, Ph.D. principal investigator
The First Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing U32 CAR-T in people with Acute Myeloid Leukaemia, run by Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd 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 13 inclusion and 17 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 Jun 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Xiaowen Tang, Ph.D. ((0086)51267781856, tangxiaowen@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse events after U32CAR-T cells infusion [Safety and Tolerability] (time frame: 28 days post administration of CAR-T-cells). 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 Jun 2025; AzTrials last refreshed its copy on 26 Oct 2026.