Relapsed or Refractory B Cell Leukemia and LymphomaPhase 1NCT07511426
U96-CAR-T-Cells For R/R B-ALL
A Phase 1 study testing U96 in people with Relapsed or Refractory B Cell Leukemia and Lymphoma, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
This study is a single-arm, open-label clinical investigation to evaluate the tolerance, safety and preliminary efficacy of CAR-T (U96) in the treatment of relapsed/refractory B-cell tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory B Cell Leukemia and Lymphoma
- What is being tested?
- U96
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2026to 7 Jan 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (All the following items must be met simultaneously)
- Patients must voluntarily sign the informed consent form and have good compliance;
- For different indications, patients must meet the following requirements:
- 2-1) Patients in the acute B lymphoblastic leukemia group:
- The age at signing the informed consent form is ≥ 18 years old, both male and female are acceptable;
- According to the standards of the National Comprehensive Cancer Network (NCCN) Acute Lymphoblastic Leukemia Clinical Practice Guidelines (2024, 2nd Edition), it is clearly diagnosed as acute B lymphoblastic leukemia;
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- According to the "Chinese Adult Acute Lymphoblastic Leukemia Diagnosis and Treatment Guidelines" (2021 Edition), one of the following conditions must be met: a. Refractory leukemia: standard induction therapy fails to achieve CR/CRi after (generally referring to 4-week regimen or Hyper-CVAD regimen) completion; b. Leukemia recurrence: patients who have achieved CR have peripheral blood or bone marrow with blast cells (proportion > 5%) or MRD positive or extramedullary lesions; 2-2) Patients in the B-cell lymphoma group:
- <!-- -->
- The age at signing the informed consent form is ≥ 18 years old, both male and female are acceptable;
- According to the standards of the National Comprehensive Cancer Network (NCCN) B-cell lymphoma clinical practice guidelines (2024, 3rd Edition), it is clearly diagnosed as B-cell lymphoma;
- Patients with B-cell lymphoma who have failed at least two-line treatment (one standardized chemotherapy regimen + one salvage chemotherapy) or have relapsed before screening. The previous treatment of B-cell lymphoma must include CD20 monoclonal antibody (excluding CD20-negative tumor patients) and anthracycline-based standardized treatment regimen. At least one of the following conditions must be met: a. Unable to undergo autologous hematopoietic stem cell transplantation; b. Refuse to undergo autologous hematopoietic stem cell transplantation; c. Relapse after autologous hematopoietic stem cell transplantation;
- At screening, the patient is in a state of disease recurrence or refractory: a) Recurrence definition: after adequate treatment achieving remission (including partial remission (PR) or complete remission (CR)), PD again occurs; b) Refractoriness definition: i. No response to the last treatment: PD during/after the last treatment or the best efficacy is SD, and the duration is less than 6 months; ii. Recurrence or progression after ASCT (requiring biopsy confirmation), including: recurrence or PD within 12 months after ASCT, if salvage treatment is received, no response (SD or PD) to the last treatment;
- Bone marrow or peripheral blood or immunohistochemistry or pathology shows CD19 antigen positive;
- According to the Lugano Lymphoma Response Evaluation Criteria (Cheson 2014), B-cell lymphoma patients have at least one evaluable lesion, or positive lesions confirmed by PET-CT;
- Eastern Cooperative Oncology Group (ECOG) performance status score is 0-3;
- At screening, there is a certain degree of bone marrow reserve, defined as: absolute lymphocyte value (ALC) ≥ 0.3×109/L, platelet (PLT) ≥ 30×109/L (allowing the result after administration);
- Have appropriate organ function, and need to meet the following standards: aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal (ULN); alanine aminotransferase (ALT) ≤ 3 times ULN (for liver function abnormalities caused by tumor infiltration, AST and ALT ≤ 5 times ULN are required); total serum bilirubin The serum bilirubin should be ≤ 2 times the ULN, except for those with Gilbert syndrome who have a combined condition; the total bilirubin should be ≤ 3 times the ULN and the direct bilirubin should be ≤ 1.5 times the ULN. Patients with Gilbert syndrome who meet these criteria can be included. The serum creatinine should be ≤ 1.5 times the ULN, or the creatinine clearance rate should be ≥ 60 mL/min (Cockcroft and Gault formula); possess the lowest level of pulmonary reserve, defined as ≤ 1 grade of dyspnea and a blood oxygen saturation > 91% in non-oxygenated state; left ventricular ejection fraction of the left heart in echocardiography should be ≥ 50%; International Normalized Ratio (INR) should be ≤ 1.5 times the ULN, and activated partial thromboplastin time (APTT) should be ≤ 1.5 times the ULN;
- The blood/urine pregnancy test for women of childbearing age during the screening period should be negative. Any male or female patient with reproductive capacity must agree to use an effective contraceptive method throughout the study process and for at least 1 year after the administration of the study treatment;
- The expected survival period should be greater than 3 months.
Who cannot join
- (Any of the following conditions will disqualify one from participating)
- Having another malignant tumor and the investigator considers that the presence of other malignant tumors may affect the current treatment;
- Any of the following conditions: positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBc-Ab), and the HBV-DNA copy number is greater than the minimum detection limit; positive for hepatitis C antibody (HCV-Ab), and the HCV-RNA copy number is greater than the minimum detection limit; positive for anti-mycoplasma antibody (TP-Ab); positive for human immunodeficiency virus (HIV) antibody;
- Existing bacterial, fungal, viral, mycoplasma or other types of infections and the investigator determines that they are difficult to control;
- Having a CNS disease other than this disease in the past or currently, such as epileptic seizures, cerebral ischemia/hemorrhage, dementia, cerebellar disease or any CNS-related autoimmune disease, and the investigator determines that it is uncontrollable;
- Before signing the informed consent form, having undergone cardiac angioplasty or stent placement within 12 months, or having NYHA classification III-IV grade congestive heart failure, or having myocardial infarction, unstable angina pectoris or the investigator determines that there is a clinically significant history of heart disease, or the patient's QTc interval is > 480 ms (QTc interval calculated using the Fridericia formula), and the left ventricular ejection fraction of the heart ultrasound is < 50%;
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- Patients with primary immunodeficiency;
- Having had a severe immediate-type hypersensitivity reaction to any drug used in this study;
- Having received live vaccines within 6 weeks before screening;
- Pregnant or lactating women;
- Active autoimmune diseases;
- Having active acute or chronic graft-versus-host disease (GVHD) at the time of signing the informed consent form, and the investigator determines that it is uncontrollable;
- Participating in any other interventional clinical research within 30 days before signing the informed consent form;
- Situations that the investigator deems unsuitable for participating in this study.
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
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Sheng-Li Xue, M.D., +8651267781139, slxue@suda.edu.cn
About this study
Official title: A Single-arm, Open-label Clinical Study on the Safety and Preliminary Efficacy of in Vivo CAR-T (U96) in the Treatment of Relapsed/Refractory B-cell Tumors
This study is a single-arm, open-label clinical investigation to evaluate the tolerance, safety and preliminary efficacy of CAR-T (U96) in the treatment of relapsed/refractory B-cell tumors. The study will be conducted in two disease types, acute B-lymphoblastic leukemia and B-cell lymphoma, with a dose escalation plan using the "3+3" method. Each dose group is planned to enroll 3 to 6 patients, with a total of approximately 30 to 48 patients to be enrolled in the entire study. After signing the informed consent form, patients will undergo screening tests. If they meet the inclusion and exclusion criteria, they will be enrolled in the study. After receiving U96 treatment, patients will be followed up. It is recommended that they stay in the hospital for at least 14 days after administration. Safety and efficacy follow-ups will be conducted at 28 days and 3, 6, 12, 18, and 24 months after treatment. The follow-up period after treatment will last for 2 years, with a long-term follow-up of 15 years to assess the efficacy and safety until the end of the study or the patient withdraws from the study. For patients who have received U96 treatment, even if they withdraw from the study early, the investigators should still conduct long-term safety follow-ups according to the protocol to evaluate the long-term safety of the product.
- Being tested
- U96
- Medical subject headings
- Recurrence, Leukemia, B-Cell, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
U96Drug
U96(CD7-targeted lentiviral vector for in vivo production of IL-6 knockdown CD19 CAR)
| Study group | Role | What they receive |
|---|---|---|
| Acute B lymphocytic leukemia group1 | Experimental | Research product: U96 (CD7-targeted lentiviral vector for in vivo production of IL-6 knockdown CD19 CAR) Dosage: The dosage was 0.2 × 10^9 TU. Administration method: Intravenous injection, single administration. Receives: Drug: U96 |
| Acute B lymphocytic leukemia group2 | Experimental | Research product: U96 (CD7-targeted lentiviral vector for in vivo production of IL-6 knockdown CD19 CAR) Dosage: The dosage was 0.4× 10^9 TU. Administration method: Intravenous injection, single administration. Receives: Drug: U96 |
| Acute B lymphocytic leukemia group3 | Experimental | Research product: U96 (CD7-targeted lentiviral vector for in vivo production of IL-6 knockdown CD19 CAR) Dosage: The dosage was 0.8× 10^9 TU. Administration method: Intravenous injection, single administration. Receives: Drug: U96 |
| Acute B lymphocytic leukemia group4 | Experimental | Research product: U96 (CD7-targeted lentiviral vector for in vivo production of IL-6 knockdown CD19 CAR) Dosage: The dosage was 1.6× 10^9 TU. Administration method: Intravenous injection, single administration. Receives: Drug: U96 |
| B-cell lymphoma group1 | Experimental | Research product: U96 (CD7-targeted lentiviral vector for in vivo production of IL-6 knockdown CD19 CAR) Dosage:The dosage was 0.2 × 10^9 TU. Administration method: Intravenous injection, single administration. Receives: Drug: U96 |
| B-cell lymphoma group2 | Experimental | Research product: U96 (CD7-targeted lentiviral vector for in vivo production of IL-6 knockdown CD19 CAR) Dosage:The dosage was 0.4 × 10^9 TU. Administration method: Intravenous injection, single administration. Receives: Drug: U96 |
| B-cell lymphoma group3 | Experimental | Research product: U96 (CD7-targeted lentiviral vector for in vivo production of IL-6 knockdown CD19 CAR) Dosage:The dosage was 0.8× 109 TU. Administration method: Intravenous injection, single administration. Receives: Drug: U96 |
| B-cell lymphoma group4 | Experimental | Research product: U96 (CD7-targeted lentiviral vector for in vivo production of IL-6 knockdown CD19 CAR) Dosage:The dosage was 1.6× 109 TU. Administration method: Intravenous injection, single administration. Receives: Drug: U96 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Description: DLT refers to any of the following conditions occurring within 28 days after cell reinfusion that are related to cell infusion: ① Hematologic DLT: Grade 4 toxicity (excluding lymphopenia) not caused by the underlying disease and taking more than 30 days to resolve to ≤ Grade 2. ② Non-hematologic DLT: Any toxicity ≥ Grade 4 that is possibly related to CAR-T therapy, or Grade 3 toxicity that requires ≥7 days to resolve to ≤ Grade 2 or to return to baseline.
Measured: Within 28 days after U96 infusion
Adverse Event (AE）
Description: Record the types, occurrence frequency and severity of adverse events (AEs) related to CAR-T, with specific definitions determined according to CTCAE v5.0.The CRS and ICANS ratings do not use CTCAE but adopt the evaluation criteria in the ASTCT standards.
Measured: 2 years
Secondary outcomes (15)
Objective Response Rate (ORR)
The acute B lymphocytic leukemia group is defined as the proportion of patients who achieved complete remission (CR), complete remission with incomplete hematological recovery (CRh), and complete remission with incomplete bone marrow recovery (CRi); the B-cell lymphoma group is defined as the complete remission rate (CR) and partial remission (PR) as determined by the investigators.
Measured: 28 days and within 3 months after infusion of U96
MRD-negative rate (for B-ALL)
The proportion of B-ALL patients with negative MRD in the bone marrow when the therapeutic effect reaches remission. B-ALL patients have residual leukemia cells in the bone marrow detected by flow cytometry below 10-⁴ and/or negative qualitative or quantitative detection of bone marrow fusion genes (if any).MRD is detected by CD19 flow cytometry immunophenotyping (bone marrow).
Measured: 28 days and within 3 months after infusion of U96
Duration of Response (DOR)
It refers to the time from the evaluation of CR/CRh/CRi in patients with acute B-cell leukemia, or from the time when patients with B-cell lymphoma first reach response (CR or PR) to disease recurrence/disease progression/death due to disease.Subjects who have not experienced disease progression or death by the time of the final data collection will be censored at the time of their last valid tumor assessment. Common reasons for censoring include, but are not limited to: ①Loss to follow-up; ②Withdrawal from the study; ③Initiation of a new anticancer therapy.
Measured: 2 years
Best Overall Response (BOR)
The Best Overall Response is defined as the proportion of patients who achieve the best response (CR or CRi) after study treatment.The review period extends from the start of infusion of U96 until the initiation of subsequent anti-cancer therapy, disease progression, withdrawal of consent, death, or study closure, whichever comes first.
Measured: 2 years
Overall Survival (OS)
Defined as the time from the date of cell infusion to the date of death from any cause. For subjects who are still alive at the time of analysis, OS will be censored on the date of last known contact.
Measured: 2 years
Progression-Free Survival (PFS)
The duration from the start of the treatment to the onset of disease progression or death for patients with B-cell lymphoma. For patients who did not experience disease progression or death by the analysis cutoff date, the last tumor evaluation time was used for censored processing.
Measured: 2 years
Relapse-Free Survival (RFS)
Defined as the time from the start of study treatment to the date of first documented relapse in patients with B-cell acute lymphoblastic leukemia (B-ALL).
Measured: 2 years
Event-Free Survival (EFS)
Defined as the time from the date of cell infusion to the occurrence of any of the following events (whichever comes first): ①Death from any cause after achieving remission ②Disease relapse or progression ③Treatment failure, defined as either lack of efficacy or discontinuation of the clinical trial due to: -Death -Adverse events -Lack of efficacy or disease progression -Initiation of new antitumor therapy
Measured: 2 years
Pharmacokinetics-AUC(0-28)
The area under the curve from 0 to 28 days for the reinfusion.
Measured: 2 years
Pharmacokinetics-Cmax
The peak concentration of the drug in the peripheral blood sample.
Measured: 2 years
Pharmacokinetics-Tmax
The time at which the peak concentration of the drug is reached in the peripheral
Measured: 2 years
IL-6
Changes in the levels of IL-6
Measured: Within 28 days after U96 infusion
Ferritin
Changes in the levels of Ferritin
Measured: Within 28 days after U96 infusion
C-reactive protein(CRP)
Changes in the levels of CRP
Measured: Within 28 days after U96 infusion
Pharmacokinetics-Proportion of B cells.
Change from baseline in peripheral blood B cell ratio
Measured: Within 28 days after U96 infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start30 Jul 2026 (estimated)
- Primary completion7 Jan 2027 (estimated)
- Study completion7 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory B Cell Leukemia and LymphomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Li Xue, MD, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511426
- Sponsor's protocol ID
- SZRBALL01
- Status last verified
- May 2026
- First submitted
- 30 Mar 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Baseline characteristics of patients, outcomes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label Clinical Study on the Safety and Preliminary Efficacy of in Vivo CAR-T (U96) in the Treatment of Relapsed/Refractory B-cell Tumors
- ClinicalTrials.gov ID
- NCT07511426
- Acronym / sponsor ID
- SZRBALL01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 30 Jul 2026 (estimated)
- Primary completion
- 7 Jan 2027 (estimated)
- Study completion
- 7 Jan 2029 (estimated)
- First posted
- 6 Apr 2026 (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 study is a single-arm, open-label clinical investigation to evaluate the tolerance, safety and preliminary efficacy of CAR-T (U96) in the treatment of relapsed/refractory B-cell tumors. The study will be conducted in two disease types, acute B-lymphoblastic leukemia and B-cell lymphoma, with a dose escalation plan using the "3+3" method. Each dose group is planned to enroll 3 to 6 patients, with a total of approximately 30 to 48 patients to be enrolled in the entire study. After signing the informed consent form, patients will undergo screening tests. If they meet the inclusion and exclusion criteria, they will be enrolled in the study. After receiving U96 treatment, patients will be followed up. It is recommended that they stay in the hospital for at least 14 days after administration. Safety and efficacy follow-ups will be conducted at 28 days and 3, 6, 12, 18, and 24 months after treatment. The follow-up period after treatment will last for 2 years, with a long-term follow-up of 15 years to assess the efficacy and safety until the end of the study or the patient withdraws from the study. For patients who have received U96 treatment, even if they withdraw from the study early, the investigators should still conduct long-term safety follow-ups according to the protocol to evaluate the long-term safety of the product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Acute B lymphocytic leukemia group1 | Experimental | Drug: U96Research product: U96 (CD7-targeted lentiviral vector for in vivo production of IL-6 knockdown CD19 CAR) Dosage: The dosage was 0.2 × 10^9 TU. Administration method: Intravenous injection, single administration. |
| Acute B lymphocytic leukemia group2 | Experimental | Drug: U96Research product: U96 (CD7-targeted lentiviral vector for in vivo production of IL-6 knockdown CD19 CAR) Dosage: The dosage was 0.4× 10^9 TU. Administration method: Intravenous injection, single administration. |
| Acute B lymphocytic leukemia group3 | Experimental | Drug: U96Research product: U96 (CD7-targeted lentiviral vector for in vivo production of IL-6 knockdown CD19 CAR) Dosage: The dosage was 0.8× 10^9 TU. Administration method: Intravenous injection, single administration. |
| Acute B lymphocytic leukemia group4 | Experimental | Drug: U96Research product: U96 (CD7-targeted lentiviral vector for in vivo production of IL-6 knockdown CD19 CAR) Dosage: The dosage was 1.6× 10^9 TU. Administration method: Intravenous injection, single administration. |
| B-cell lymphoma group1 | Experimental | Drug: U96Research product: U96 (CD7-targeted lentiviral vector for in vivo production of IL-6 knockdown CD19 CAR) Dosage:The dosage was 0.2 × 10^9 TU. Administration method: Intravenous injection, single administration. |
| B-cell lymphoma group2 | Experimental | Drug: U96Research product: U96 (CD7-targeted lentiviral vector for in vivo production of IL-6 knockdown CD19 CAR) Dosage:The dosage was 0.4 × 10^9 TU. Administration method: Intravenous injection, single administration. |
| B-cell lymphoma group3 | Experimental | Drug: U96Research product: U96 (CD7-targeted lentiviral vector for in vivo production of IL-6 knockdown CD19 CAR) Dosage:The dosage was 0.8× 109 TU. Administration method: Intravenous injection, single administration. |
| B-cell lymphoma group4 | Experimental | Drug: U96Research product: U96 (CD7-targeted lentiviral vector for in vivo production of IL-6 knockdown CD19 CAR) Dosage:The dosage was 1.6× 109 TU. Administration method: Intravenous injection, single administration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- (All the following items must be met simultaneously)
- <!-- -->
Key exclusion criteria (14 listed)
- (Any of the following conditions will disqualify one from participating)
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 |
|---|---|---|
| U96U96(CD7-targeted lentiviral vector for in vivo production of IL-6 knockdown CD19 CAR) | Drug | Acute B lymphocytic leukemia group1, Acute B lymphocytic leukemia group2, Acute B lymphocytic leukemia group3, Acute B lymphocytic leukemia group4, B-cell lymphoma group1, B-cell lymphoma group2, B-cell lymphoma group3, B-cell lymphoma group4 |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: Within 28 days after U96 infusion
Description: DLT refers to any of the following conditions occurring within 28 days after cell reinfusion that are related to cell infusion: ① Hematologic DLT: Grade 4 toxicity (excluding lymphopenia) not caused by the underlying disease and taking more than 30 days to resolve to ≤ Grade 2. ② Non-hematologic DLT: Any toxicity ≥ Grade 4 that is possibly related to CAR-T therapy, or Grade 3 toxicity that requires ≥7 days to resolve to ≤ Grade 2 or to return to baseline.
Adverse Event (AE）
Time frame: 2 years
Description: Record the types, occurrence frequency and severity of adverse events (AEs) related to CAR-T, with specific definitions determined according to CTCAE v5.0.The CRS and ICANS ratings do not use CTCAE but adopt the evaluation criteria in the ASTCT standards.
15 secondary outcomes
Objective Response Rate (ORR)
Time frame: 28 days and within 3 months after infusion of U96
MRD-negative rate (for B-ALL)
Time frame: 28 days and within 3 months after infusion of U96
Duration of Response (DOR)
Time frame: 2 years
Best Overall Response (BOR)
Time frame: 2 years
Overall Survival (OS)
Time frame: 2 years
Progression-Free Survival (PFS)
Time frame: 2 years
Relapse-Free Survival (RFS)
Time frame: 2 years
Event-Free Survival (EFS)
Time frame: 2 years
Pharmacokinetics-AUC(0-28)
Time frame: 2 years
Pharmacokinetics-Cmax
Time frame: 2 years
Pharmacokinetics-Tmax
Time frame: 2 years
IL-6
Time frame: Within 28 days after U96 infusion
Ferritin
Time frame: Within 28 days after U96 infusion
C-reactive protein(CRP)
Time frame: Within 28 days after U96 infusion
Pharmacokinetics-Proportion of B cells.
Time frame: Within 28 days after U96 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 28 May 2026.
- Individual participant dataSharing planned: Yes. Baseline characteristics of patients, outcomes
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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.
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 U96 in people with Relapsed or Refractory B Cell Leukemia and Lymphoma, run by The First Affiliated Hospital of Soochow University 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 19 inclusion and 14 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 28 May 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 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 Sheng-Li Xue (008651267781139, slxue@suda.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: Within 28 days after U96 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 28 May 2026.