B-Cell Acute Lymphoblastic Leukemia, AdultEarly Phase 1NCT07277504
Autologous Bedside CD19 CAR T-cell Therapy for B-ALL
A Early Phase 1 study testing CD19 CAR T cells in people with B-Cell Acute Lymphoblastic Leukemia, Adult, run by The General Hospital of Western Theater Command at 1 site in China.
Trial summary
The purpose of this clinical trial is to learn if autologous bedside CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy works to treat B-cell acute lymphoblastic leukemia (B-ALL) in adults. It will also learn about the safety and efficacy of the autologous bedside CD19 CAR-T cell product. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- B-Cell Acute Lymphoblastic Leukemia, Adult
- What is being tested?
- CD19 CAR T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 31 Dec 2031
- Phase
- Early 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 70 years inclusive at the time of signing informed consent.
- Documented diagnosis of B-cell acute lymphoblastic leukemia (B-ALL) according to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Acute Lymphoblastic Leukemia (2018, Version 1) or World Health Organization (WHO) classification criteria.
- CD19 expression confirmed by flow cytometry, immunohistochemistry, or pathology on bone marrow, peripheral blood, or tissue specimens. For patients for whom current sampling is not clinically feasible, results from testing performed within 60 days prior to informed consent may be acceptable, as determined by the investigator.
- Life expectancy ≥12 weeks in the opinion of the investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
- Adequate organ function as demonstrated by the most recent assessment during the screening period, defined as:
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- Creatinine clearance ≥60 mL/min (calculated using the Cockcroft-Gault formula)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × upper limit of normal (ULN)
- Total bilirubin ≤1.5 × ULN (for patients with documented Gilbert's syndrome, total bilirubin ≤2.5 × ULN is acceptable)
- For women of childbearing potential (WOCBP), a negative serum pregnancy test must be documented within 7 days prior to enrollment. WOCBP and male patients with partners who are WOCBP must agree to use highly effective contraceptive methods from the screening period through 12 months after CAR-T cell infusion. Women are considered not of childbearing potential if they are postmenopausal for at least 1 year or have documented evidence of surgical sterilization or congenital infertility. Women who are pregnant or breastfeeding are excluded from this study.
- Ability to understand and willingness to provide written informed consent prior to initiation of any study-specific procedures.
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures, including long-term follow-up for up to 15 years.
Who cannot join
- Patients meeting any of the following criteria are not eligible for enrollment:
- Active central nervous system (CNS) involvement by B-ALL, defined as CNS-2 or CNS-3 status according to standard criteria.
- History of another malignancy within 2 years prior to screening, except for adequately treated basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
- Patients who previously received CAR-T cell therapy and experienced Grade ≥4 cytokine release syndrome (CRS) or neurotoxicity are specifically excluded.
- Treatment with any investigational or approved anti-B-ALL therapeutic agent within 5 half-lives prior to enrollment (excluding supportive care medications).
- Radioimmunotherapy or radiotherapy within 8 weeks prior to enrollment.
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- Receipt of live attenuated vaccine within 4 weeks prior to screening.
- Current or anticipated use of systemic corticosteroids at high dose (defined as a total cumulative dose equivalent to ≥60 mg dexamethasone or equivalent corticosteroid) within 4 weeks prior to lymphodepletion chemotherapy. Physiologic replacement doses, topical, inhaled, nasal, and ophthalmic corticosteroids are permitted.
- Active acute or chronic graft-versus-host disease (GVHD) requiring systemic treatment within 4 weeks prior to CAR-T cell infusion.
- Major surgical procedure within 3 months prior to screening.
- Active CNS disorder or history of irreversible severe CNS toxicity from prior B-ALL therapy resulting in organic brain lesions or CNS dysfunction, including but not limited to seizure disorder, cerebrovascular accident, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
- History of hypertensive crisis or hypertensive encephalopathy within 3 months prior to screening.
- Any uncontrolled cardiovascular disease within 6 months prior to enrollment, or any of the following:
- Ventricular or atrial arrhythmia ≥Grade 2
- Bradycardia ≥Grade 2
- Myocardial infarction
- Severe or unstable angina pectoris
- Symptomatic congestive heart failure
- Cerebrovascular accident or transient ischemic attack
- Pulmonary embolism
- Deep vein thrombosis
- Poorly controlled hypertension despite standard medical management
- Left ventricular ejection fraction (LVEF) <45% as assessed by echocardiography or multigated acquisition (MUGA) scan at screening
- Any uncontrolled pulmonary disease within 6 months prior to enrollment, or any of the following:
- Pulmonary embolism
- Chronic obstructive pulmonary disease
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis
- Evidence of active pneumonia on chest computed tomography (CT) scan at screening
- Symptomatic or uncontrolled interstitial lung disease
- Clinically significant pulmonary function abnormalities Note: History of radiation pneumonitis/pulmonary fibrosis in a radiation field is permitted if asymptomatic.
- Active bacterial, fungal, protozoal, or viral infection that is not adequately controlled despite appropriate therapy at the time of enrollment, or positive blood culture within 7 days prior to enrollment.
- Known active infection with any of the following:
- Hepatitis B virus (HBV): Positive HBV surface antigen (HBsAg) or HBV core antibody (HBcAb) with detectable HBV DNA above the normal range
- Hepatitis C virus (HCV): Positive HCV antibody with detectable HCV RNA above the normal range
- Human immunodeficiency virus (HIV): Positive HIV antibody
- Human T-lymphotropic virus (HTLV): Positive HTLV antibody
- Treponema pallidum (syphilis): Positive T. pallidum antibody
- Cytomegalovirus (CMV): Positive CMV DNA by polymerase chain reaction (PCR)
- Legally incapacitated individuals under guardianship or conservatorship.
- Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study or ability to provide informed consent.
- Any abnormal finding, medical condition, or laboratory test result during screening that, in the investigator's judgment, may jeopardize patient safety or interfere with study conduct or interpretation of results.
- Any planned medical or surgical intervention that would interfere with the conduct of the study.
- Contraindication to any medication that may be required during the study, including but not limited to lymphodepletion chemotherapy agents (fludarabine, cyclophosphamide) and medications for management of adverse reactions (e.g., tocilizumab for CRS management, corticosteroids for ICANS management).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Xiao Wang, M.D. & Ph.D. contact
China1 site
The General Hospital of Western Theater Command
Chengdu, Sichuan
Xiao Wang, M.D. & Ph.D., +8618980555822, xxwx@foxmail.com
Hai Yi, M.D. & Ph.D.
About this study
Official title: Clinical Study on the Safety and Efficacy of Bedside CD19 CAR T-cell Therapy for B-cell Acute Lymphoblastic Leukemia
The purpose of this clinical trial is to learn if autologous bedside CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy works to treat B-cell acute lymphoblastic leukemia (B-ALL) in adults. It will also learn about the safety and efficacy of the autologous bedside CD19 CAR-T cell product.
The main questions it aims to answer are:
Read more
- What adverse events occur and the incidence rate of dose-limiting toxicities (DLTs) within 28 days and CAR-T-related adverse events (AEs) after the autologous CD19 CAR-T cell infusion for B-ALL?
- Which dose level is the optimal biological dose (OBD)?
- What is the rate of minimal residual disease (MRD) negativity, complete remission (CR) or complete remission with incomplete hematologic recovery (CRi), duration of response (DOR), and overall survival (OS)?
Participants will:
- Receive autologous bedside CD19 CAR T-cell therapy on Day 0.
- Be hospitalized for at least 7 days post-infusion for close safety monitoring and remain within 2 hours of the treatment facility for at least 28 days.
- Visit the clinic at Day 7, Day 14, Day 28, then monthly for up to 12 months after CAR-T cells infusion, with continued long-term follow-up for safety and persistence.
- Being tested
- CD19 CAR T cells
- Keywords
- CAR-T, CAR T-cell therapy, B-ALL
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19 CAR T cellsDrug
intravenous injection of CD19 CAR-T cells
| Study group | Role | What they receive |
|---|---|---|
| CAR T-cell treatment | Experimental | Not described Receives: Drug: CD19 CAR T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence rate of CAR-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.
Measured: Up to 28 days after injection
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 CAR-T infusion will be recorded in time, including severity, occurrence time, duration, treatment methods and prognosis.
Measured: Up to 28 days after infusion
Secondary outcomes (4)
the rate of minimal residual disease (MRD) negativity
Measured: up to 1 year after CAR-T cells infusion
overall response rate (ORR)
ORR includes complete remission (CR) or complete remission with incomplete hematologic recovery (CRi), or complete Remission with Partial Hematologic Recovery (CRh).
Measured: up to 1 year after CAR-T cells infusiion
Duration of Response (DOR)
Measured: up to 1 year after CAR-T cells infusion
overall survival (OS)
Measured: up to 1 year after CAR-T infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-Cell Acute Lymphoblastic Leukemia, AdultStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The General Hospital of Western Theater Command
- Sponsor type
- University, hospital or other
- Collaborators
- Chengdu Ucello Biotechnology Co., Ltd.
- Responsible party
- Principal investigator, Yihai2024, The General Hospital of Western Theater Command
- Investigators
- Hai Yi, M.D. & Ph.D., Principal investigator, The General Hospital of Western Theater Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277504
- Sponsor's protocol ID
- YI_CAR-T_B-ALL_01
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: safety and efficacy data will be shared in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety and Efficacy of Bedside CD19 CAR T-cell Therapy for B-cell Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT07277504
- Acronym / sponsor ID
- YI_CAR-T_B-ALL_01
- Keywords
- CAR-T, CAR T-cell therapy, B-ALL
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The General Hospital of Western Theater CommandUniversity, hospital or other
- Collaborators
- Chengdu Ucello Biotechnology Co., Ltd.
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 11 Dec 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 autologous bedside CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy works to treat B-cell acute lymphoblastic leukemia (B-ALL) in adults. It will also learn about the safety and efficacy of the autologous bedside CD19 CAR-T cell product.
The main questions it aims to answer are:
- What adverse events occur and the incidence rate of dose-limiting toxicities (DLTs) within 28 days and CAR-T-related adverse events (AEs) after the autologous CD19 CAR-T cell infusion for B-ALL?
- Which dose level is the optimal biological dose (OBD)?
- What is the rate of minimal residual disease (MRD) negativity, complete remission (CR) or complete remission with incomplete hematologic recovery (CRi), duration of response (DOR), and overall survival (OS)?
Participants will:
- Receive autologous bedside CD19 CAR T-cell therapy on Day 0.
- Be hospitalized for at least 7 days post-infusion for close safety monitoring and remain within 2 hours of the treatment facility for at least 28 days.
- Visit the clinic at Day 7, Day 14, Day 28, then monthly for up to 12 months after CAR-T cells infusion, with continued long-term follow-up for safety and persistence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR T-cell treatment | Experimental | Drug: CD19 CAR T cells |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18 to 70 years inclusive at the time of signing informed consent.
- Documented diagnosis of B-cell acute lymphoblastic leukemia (B-ALL) according to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Acute Lymphoblastic Leukemia (2018, Version 1) or World Health Organization (WHO) classification criteria.
- CD19 expression confirmed by flow cytometry, immunohistochemistry, or pathology on bone marrow, peripheral blood, or tissue specimens. For patients for whom current sampling is not clinically feasible, results from testing performed within 60 days prior to informed consent may be acceptable, as determined by the investigator.
- Life expectancy ≥12 weeks in the opinion of the investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
Key exclusion criteria (43 listed)
- Active central nervous system (CNS) involvement by B-ALL, defined as CNS-2 or CNS-3 status according to standard criteria.
- History of another malignancy within 2 years prior to screening, except for adequately treated basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
- Patients who previously received CAR-T cell therapy and experienced Grade ≥4 cytokine release syndrome (CRS) or neurotoxicity are specifically excluded.
- Treatment with any investigational or approved anti-B-ALL therapeutic agent within 5 half-lives prior to enrollment (excluding supportive care medications).
- Radioimmunotherapy or radiotherapy within 8 weeks prior to enrollment.
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 |
|---|---|---|
| CD19 CAR T cellsintravenous injection of CD19 CAR-T cells | Drug | CAR T-cell treatment |
Primary outcome
the incidence rate of CAR-T-related adverse events
Time frame: Up to 28 days after injection
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.
The incidence rate of Dose limited toxicity (DLTs)
Time frame: Up to 28 days after 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 CAR-T infusion will be recorded in time, including severity, occurrence time, duration, treatment methods and prognosis.
4 secondary outcomes
the rate of minimal residual disease (MRD) negativity
Time frame: up to 1 year after CAR-T cells infusion
overall response rate (ORR)
Time frame: up to 1 year after CAR-T cells infusiion
Duration of Response (DOR)
Time frame: up to 1 year after CAR-T cells infusion
overall survival (OS)
Time frame: up to 1 year after CAR-T 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 11 Dec 2025.
- Individual participant dataSharing planned: Yes. safety and efficacy data 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.
Xiao Wang, M.D. & Ph.D. contact
Hai Yi, M.D. & Ph.D. principal investigator
The General Hospital of Western Theater Command
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CD19 CAR T cells in people with B-Cell Acute Lymphoblastic Leukemia, Adult, run by The General Hospital of Western Theater Command 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 12 inclusion and 43 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: opening soon, as of the sponsor's last update on 11 Dec 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Hai Yi, M.D. & Ph.D. (+8613699418229, yihaimail@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence rate of CAR-T-related adverse events (time frame: Up to 28 days after injection). 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 11 Dec 2025.