Precursor B-Cell Lymphoblastic Leukemia-LymphomaPhase 1/2Phase I/IINCT06880913
Nanobody-Based CD19/CD22 Tandem Dual CAR-T Therapy for R/R B-ALL
A Phase 1/2 study testing Nanobody-Based CD19/CD22 Tandem Dual CAR-T in people with Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, run by Peking University People's Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of Nanobody-Based CD19/CD22 Tandem Dual Chimeric Antigen Receptor (CAR) T-cell therapy in patients with relapsed or refractory B-ALL Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
- What is being tested?
- Nanobody-Based CD19/CD22 Tandem Dual CAR-T
- 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
- 14 Nov 2024to 31 Dec 2028
- 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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The subject or their legally authorized representative (guardian) understands the study and voluntarily signs the informed consent form (ICF).
- Male or female, aged 12 to 65 years at the time of signing the ICF (inclusive of the cutoff values).
- Expected survival of at least 12 weeks. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at the time of signing the ICF.
- At the time of signing the ICF, the patient must be diagnosed with R/R B-ALL and meet the following criteria:
- Bone marrow morphological examination at screening shows >5% blasts in the bone marrow, and/or cerebrospinal fluid (CSF) analysis detects leukemic cells, and/or the presence of measurable extramedullary lesions, defined as:
- Any lymph node or mass with an axial diameter >1.5 cm Any extranodal lesion with an axial diameter >1.0 cm
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- Flow cytometry confirms CD19 or CD22 positivity in tumor cells from bone marrow, peripheral blood, or cerebrospinal fluid, or pathology confirms CD19 or CD22 positivity in lymph nodes/masses or extranodal lesions.
- Eligibility for Phase II (RP2D) is restricted to patients with R/R B-ALL who have failed prior immunotherapies, including blinatumomab, inotuzumab ozogamicin, or prior single-target CAR-T therapy.
- Adequate organ function, meeting the following laboratory criteria:
- Liver function:
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5× upper limit of normal (ULN) Total bilirubin ≤2× ULN
- Renal function:
- Adults: Serum creatinine clearance ≥60 mL/min (using the Cockcroft-Gault formula) or creatinine ≤1.5× ULN
- Children: Serum creatinine levels must not exceed the following values:
- 10-13 years: ≤1.2 mg/dL Males 13-16 years: ≤1.5 mg/dL Females ≥13 years: ≤1.4 mg/dL Males ≥16 years: ≤1.7 mg/dL Blood oxygen saturation (SpO₂) >92% on room air. Fertile male and female subjects of reproductive potential must agree to use effective contraception from the time of informed consent until 2 years after administration of the study drug.
- Women of childbearing potential (WOCBP) include premenopausal women and those within 2 years post-menopause.
- A negative blood pregnancy test is required for all female participants of childbearing potential at screening.
Who cannot join
- Subjects who meet any of the following criteria will be excluded from the study:
- History of central nervous system (CNS) diseases, including but not limited to:
- Epilepsy
- Paralysis
- Aphasia
- Stroke
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- Severe brain injury
- Dementia
- Parkinson's disease
- Neuropathy
- History of autoimmune diseases requiring systemic immunosuppressive therapy within 2 years prior to signing the ICF, including but not limited to:
- Crohn's disease
- Rheumatoid arthritis
- Systemic lupus erythematosus (SLE)
- Systemic sclerosis
- Inflammatory bowel disease (IBD)
- Vasculitis
- Psoriasis
- Presence of any uncontrolled active infection at the time of signing the ICF or within 4 weeks prior to apheresis that requires antibiotic, antiviral, or antifungal treatment.
- Positive virological or infectious disease markers, including:
- Hepatitis B virus (HBV): Subjects with positive HBsAg or HBcAb-positive at screening must have undetectable HBV DNA in peripheral blood to be eligible; otherwise, they should be excluded.
- Hepatitis C virus (HCV): Subjects with positive HCV antibodies and detectable HCV RNA should be excluded.
- Human immunodeficiency virus (HIV) antibody-positive subjects should be excluded.
- Cytomegalovirus (CMV) DNA test-positive subjects should be excluded.
- Epstein-Barr virus (EBV) DNA test-positive subjects should be excluded.
- Positive serological or non-specific antibodies for Treponema pallidum (syphilis).
- Clinically significant cardiovascular diseases, including any of the following:
- QTc interval ≥480 ms (Fridericia correction formula)
- New York Heart Association (NYHA) Class II or higher heart failure
- Unstable angina or acute myocardial infarction within 6 months prior to signing the ICF
- Left ventricular ejection fraction (LVEF) <50%
- Poorly controlled hypertension (as determined by the investigator)
- Clinically significant arrhythmias or those requiring antiarrhythmic treatment, including:
- Persistent ventricular tachycardia
- Ventricular fibrillation
- Torsades de pointes
- Complete left bundle branch block
- History of severe hypersensitivity or allergy to any components of the study drug.
- Receipt of any investigational drug therapy or other systemic antitumor therapy within 4 weeks before apheresis (or 5 half-lives of the drug, whichever is longer, as determined by the investigator).
- Receipt of extensive radiotherapy within 4 weeks prior to signing the ICF, except for palliative radiotherapy for non-target lesions within 2 weeks before signing the ICF or as expected during the study.
- Unresolved toxicity from prior antitumor therapy that has not returned to Grade 1 or baseline levels at the time of signing the ICF, except for hair loss and pigmentation (per NCI-CTCAE v5.0).
- Requirement for systemic corticosteroids or other immunosuppressive therapy (≥10 mg/day prednisone or equivalent) within 3 days prior to apheresis or during the study period, except for:
- Intranasal, inhaled, or topical steroids, or localized steroid injections (e.g., intra-articular injections)
- Systemic corticosteroids ≤10 mg/day prednisone (or equivalent physiological dose)
- Steroids as prophylaxis for allergic reactions (e.g., pre-medication before contrast-enhanced CT)
- Steroids used for symptomatic treatment of transfusion-related reactions
- Major surgery within 4 weeks prior to signing the ICF (excluding routine biopsy procedures) or planned major surgery during the study period.
- History of active tuberculosis infection within 1 year prior to signing the ICF, except for subjects with a history of tuberculosis more than 1 year ago, provided that the investigator determines there is no evidence of active tuberculosis.
- History of other primary malignancies within 5 years prior to signing the ICF, except for:
- Adequately treated carcinoma in situ of the cervix
- Localized basal cell carcinoma or squamous cell carcinoma of the skin
- Receipt of live-attenuated or inactivated vaccines within 4 weeks before signing the ICF or planned vaccination during the screening period.
- Any other condition or complication that, in the investigator's judgment, may affect adherence to the study protocol or make the subject unsuitable for participation.
- Pregnancy or lactation.
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
Deparment of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Xiaojun Huang, doctor, 8601088326666, huangxiaojun@bjmu.edu.cn
About this study
Official title: A Phase I Dose-Escalation and Phase II Study of Nanobody-Based CD19/CD22 Tandem Dual Chimeric Antigen Receptor (CAR) T-cell Therapy in Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
To evaluate the efficacy and safety of Nanobody-Based CD19/CD22 Tandem Dual Chimeric Antigen Receptor (CAR) T-cell therapy in patients with relapsed or refractory B-ALL
Read the detailed description
This Phase I/II study aims to evaluate the safety, tolerability, and efficacy of Nanobody-Based CD19/CD22 Tandem Dual CAR-T-cell therapy in patients with relapsed or refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL), particularly those who have failed or relapsed after CD19- or CD22-targeted CAR-T or antibody-based immunotherapy.
In the Phase I portion of the study, a 3+3 dose-escalation design will be employed to evaluate safety and determine the optimal dose of Nanobody-Based CD19-22 Tandem CAR-T cells. Three dose levels will be tested: 0.3 × 10⁶ cells/kg, 1.0 × 10⁶ cells/kg, and 2.0 × 10⁶ cells/kg. The recommended Phase II dose (RP2D) will be established based on safety data, dose-limiting toxicities (DLTs), and preliminary efficacy outcomes.
The Phase II portion will focus on evaluating the efficacy of nanobody-based CD19/CD22 tandem dual CAR-T therapy at the RP2D in patients with R/R B-ALL who are refractory to or have relapsed after prior immunotherapies, including blinatumomab, inotuzumab ozogamicin, or prior single-target CAR-T therapy, with key endpoints including overall response rate (ORR), duration of response (DOR), disease-free survival (DFS), and overall survival (OS).Safety assessments will include cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), immune effector cell-associated hemophagocytic syndrome (IEC-HS), and immune effector cell-associated hematotoxicity (ICAHT) will also be conducted throughout the study.
This study seeks to address the unmet clinical need for effective treatment options in patients with R/R B-ALL, particularly those who have exhausted prior CD19- or CD22-directed therapies.
- Being tested
- Nanobody-Based CD19/CD22 Tandem Dual CAR-T
- Keywords
- R/R B-ALL
- Medical subject headings
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanobody-Based CD19/CD22 Tandem Dual CAR-TBiological
Phase I: Patients will receive a single infusion of autologous CD19/CD22 dual CAR-T cells at one of three dose levels (0.3 × 10⁶ cells/kg, 1.0 × 10⁶ cells/kg, or 2.0 × 10⁶ cells/kg) following fludarabine (25-30mg/m2*3d) and cyclophosphamide (250-300mg/m2*3d) (FC) lymphodepleting chemotherapy.
Phase II: Patients will receive autologous CD19/CD22 dual CAR-T cells at the RP2D following FC lymphodepleting chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| CD19/CD22 Tandem Dual CAR-T | Experimental | Eligible patients will be treated with Nanobody-Based CD19/CD22 Tandem Dual CAR-T Receives: Biological: Nanobody-Based CD19/CD22 Tandem Dual CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity (DLT)
CRS and ICANS will be assessed per ASTCT (2019), while other AEs follow CTCAE v5.0. DLTs are CAR-T-related AEs (possibly, likely, or definitely related) that occur within 28 days post-infusion and meet the following criteria:
Grade 4+ CRS, or Grade 3 CRS unresolved to ≤ Grade 2 within 7 days. Grade 3+ non-hematologic toxicity unresolved to ≤ Grade 2 within 7 days. Grade 4+ ICANS, or Grade 3 ICANS unresolved to ≤ Grade 2 within 3 days. Grade 4+ hematologic toxicity (excluding lymphopenia) lasting >28 days. Grade 3+ hypersensitivity reaction. Any unexpected toxicity requiring study discontinuation.
Exemptions:
Rapid hypersensitivity resolving to ≤ Grade 2 in 2 hours. Reversible Grade 3 AEs lasting ≤7 days. Transient CRS-related organ dysfunction, resolving in ≤7 days per SRC. All DLTs are reviewed by the Safety Review Committee.
Measured: Day28 after CAR-T cell infusion
Overall Response Rate (ORR)
Time Frame: Within 3 months after CAR-T cell infusion Definition: ORR is defined as the proportion of patients achieving complete remission (CR), complete remission with incomplete hematologic recovery (CRi), or morphologic leukemia-free state (MLFS), as per European LeukemiaNet (ELN) 2022 criteria.
Response Criteria (ELN 2022):
Complete Remission (CR):
<5% bone marrow blasts Absolute neutrophil count (ANC) ≥1.0 × 10⁹/L Platelet count ≥100 × 10⁹/L No evidence of extramedullary disease Full hematologic recovery
Complete Remission with Incomplete Hematologic Recovery (CRi):
<5% bone marrow blasts ANC <1.0 × 10⁹/L and/or platelet count <100 × 10⁹/L No evidence of extramedullary disease
Morphologic Leukemia-Free State (MLFS):
<5% bone marrow blasts No hematologic recovery required (ANC and platelet counts may remain low) No extramedullary leukemia
Measured: Within 3 months after CAR-T cell infusion
Secondary outcomes (2)
Disease-Free Survival (DFS)
DFS is defined as the duration from the first confirmed complete remission (CR), complete remission with incomplete hematologic recovery (CRi), or morphologic leukemia-free state (MLFS) to the occurrence of:
Bone marrow relapse - defined as the recurrence of ≥5% blasts in the bone marrow.
Extramedullary relapse - defined as the recurrence of leukemia outside the bone marrow, such as in the central nervous system (CNS), lymph nodes, liver, spleen, or other organs.
Death from any cause, whichever occurs first.
Measured: 2-year
Overall Survival (OS)
Overall Survival (OS) is defined as the duration from the first CAR-T cell infusion to the date of death from any cause. Patients who are still alive at the time of analysis will be censored at their last known follow-up date.
Measured: 2-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start14 Nov 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Precursor B-Cell Lymphoblastic Leukemia-LymphomaStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Phase I, a traditional 3+3 dose-escalation design and determine the recommended Phase II dose; Phase II, a single-arm, open-label study design.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hebei Senlang Biotechnology Inc., Ltd.
- Responsible party
- Principal investigator, Xiao-Jun Huang, Peking University People's Hospital
- Investigators
- Xiao-jun Huang, MD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880913
- Sponsor's protocol ID
- 2024PHD024-001
- Acronym
- Phase I/II
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2025
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose-Escalation and Phase II Study of Nanobody-Based CD19/CD22 Tandem Dual Chimeric Antigen Receptor (CAR) T-cell Therapy in Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT06880913
- Acronym / sponsor ID
- Phase I/II / 2024PHD024-001
- Keywords
- R/R B-ALL
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Hebei Senlang Biotechnology Inc., Ltd.
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 18 Mar 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.
To evaluate the efficacy and safety of Nanobody-Based CD19/CD22 Tandem Dual Chimeric Antigen Receptor (CAR) T-cell therapy in patients with relapsed or refractory B-ALL
Detailed description
This Phase I/II study aims to evaluate the safety, tolerability, and efficacy of Nanobody-Based CD19/CD22 Tandem Dual CAR-T-cell therapy in patients with relapsed or refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL), particularly those who have failed or relapsed after CD19- or CD22-targeted CAR-T or antibody-based immunotherapy.
In the Phase I portion of the study, a 3+3 dose-escalation design will be employed to evaluate safety and determine the optimal dose of Nanobody-Based CD19-22 Tandem CAR-T cells. Three dose levels will be tested: 0.3 × 10⁶ cells/kg, 1.0 × 10⁶ cells/kg, and 2.0 × 10⁶ cells/kg. The recommended Phase II dose (RP2D) will be established based on safety data, dose-limiting toxicities (DLTs), and preliminary efficacy outcomes.
The Phase II portion will focus on evaluating the efficacy of nanobody-based CD19/CD22 tandem dual CAR-T therapy at the RP2D in patients with R/R B-ALL who are refractory to or have relapsed after prior immunotherapies, including blinatumomab, inotuzumab ozogamicin, or prior single-target CAR-T therapy, with key endpoints including overall response rate (ORR), duration of response (DOR), disease-free survival (DFS), and overall survival (OS).Safety assessments will include cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), immune effector cell-associated hemophagocytic syndrome (IEC-HS), and immune effector cell-associated hematotoxicity (ICAHT) will also be conducted throughout the study.
This study seeks to address the unmet clinical need for effective treatment options in patients with R/R B-ALL, particularly those who have exhausted prior CD19- or CD22-directed therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase I, a traditional 3+3 dose-escalation design and determine the recommended Phase II dose; Phase II, a single-arm, open-label study design.
| Arm | Type | Receives |
|---|---|---|
| CD19/CD22 Tandem Dual CAR-T | Experimental | Biological: Nanobody-Based CD19/CD22 Tandem Dual CAR-TEligible patients will be treated with Nanobody-Based CD19/CD22 Tandem Dual CAR-T |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- The subject or their legally authorized representative (guardian) understands the study and voluntarily signs the informed consent form (ICF).
- Male or female, aged 12 to 65 years at the time of signing the ICF (inclusive of the cutoff values).
- Expected survival of at least 12 weeks. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 at the time of signing the ICF.
- At the time of signing the ICF, the patient must be diagnosed with R/R B-ALL and meet the following criteria:
- Bone marrow morphological examination at screening shows >5% blasts in the bone marrow, and/or cerebrospinal fluid (CSF) analysis detects leukemic cells, and/or the presence of measurable extramedullary lesions, defined as:
Key exclusion criteria (54 listed)
- History of central nervous system (CNS) diseases, including but not limited to:
- History of autoimmune diseases requiring systemic immunosuppressive therapy within 2 years prior to signing the ICF, including but not limited to:
- Presence of any uncontrolled active infection at the time of signing the ICF or within 4 weeks prior to apheresis that requires antibiotic, antiviral, or antifungal treatment.
- Positive virological or infectious disease markers, including:
- Clinically significant cardiovascular diseases, including any of the following:
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 |
|---|---|---|
| Nanobody-Based CD19/CD22 Tandem Dual CAR-TPhase I: Patients will receive a single infusion of autologous CD19/CD22 dual CAR-T cells at one of three dose levels (0.3 × 10⁶ cells/kg, 1.0 × 10⁶ cells/kg, or 2.0 × 10⁶ cells/kg) following fludarabine (25-30mg/m2*3d) and cyclophosphamide (250-300mg/m2*3d) (FC) lymphodepleting chemotherapy. Phase II: Patients will receive autologous CD19/CD22 dual CAR-T cells at the RP2D following FC lymphodepleting chemotherapy. | Biological | CD19/CD22 Tandem Dual CAR-T |
Primary outcome
Dose-Limiting Toxicity (DLT)
Time frame: Day28 after CAR-T cell infusion
CRS and ICANS will be assessed per ASTCT (2019), while other AEs follow CTCAE v5.0. DLTs are CAR-T-related AEs (possibly, likely, or definitely related) that occur within 28 days post-infusion and meet the following criteria: Grade 4+ CRS, or Grade 3 CRS unresolved to ≤ Grade 2 within 7 days. Grade 3+ non-hematologic toxicity unresolved to ≤ Grade 2 within 7 days. Grade 4+ ICANS, or Grade 3 ICANS unresolved to ≤ Grade 2 within 3 days. Grade 4+ hematologic toxicity (excluding lymphopenia) lasting >28 days. Grade 3+ hypersensitivity reaction. Any unexpected toxicity requiring study discontinuation. Exemptions: Rapid hypersensitivity resolving to ≤ Grade 2 in 2 hours. Reversible Grade 3 AEs lasting ≤7 days. Transient CRS-related organ dysfunction, resolving in ≤7 days per SRC. All DLTs are reviewed by the Safety Review Committee.
Overall Response Rate (ORR)
Time frame: Within 3 months after CAR-T cell infusion
Time Frame: Within 3 months after CAR-T cell infusion Definition: ORR is defined as the proportion of patients achieving complete remission (CR), complete remission with incomplete hematologic recovery (CRi), or morphologic leukemia-free state (MLFS), as per European LeukemiaNet (ELN) 2022 criteria. Response Criteria (ELN 2022): Complete Remission (CR): <5% bone marrow blasts Absolute neutrophil count (ANC) ≥1.0 × 10⁹/L Platelet count ≥100 × 10⁹/L No evidence of extramedullary disease Full hematologic recovery Complete Remission with Incomplete Hematologic Recovery (CRi): <5% bone marrow blasts ANC <1.0 × 10⁹/L and/or platelet count <100 × 10⁹/L No evidence of extramedullary disease Morphologic Leukemia-Free State (MLFS): <5% bone marrow blasts No hematologic recovery required (ANC and platelet counts may remain low) No extramedullary leukemia
2 secondary outcomes
Disease-Free Survival (DFS)
Time frame: 2-year
Overall Survival (OS)
Time frame: 2-year
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 30 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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-jun Huang, MD principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nanobody-Based CD19/CD22 Tandem Dual CAR-T in people with Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, run by Peking University People's 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 17 inclusion and 54 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 30 Mar 2026. 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 MENG LV, MD, PhD (+861088324637, drlvmeng@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicity (DLT) (time frame: Day28 after CAR-T cell infusion). 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 30 Mar 2026.