B Cell LymphomaPhase 1NCT07093073
Clinical Study of U01（ssCART-19） in Patients With B-Cell Lymphoma
A Phase 1 study testing ssCART-19 in people with B Cell Lymphoma, 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 evaluating the efficacy and safety of U01 (ssCART-19) in patients with relapsed or refractory B-cell lymphoma. Read more about this study
- Who is it for?
- Ages 2 to 75 years
- Conditions the study is for
- B Cell Lymphoma
- What is being tested?
- ssCART-19
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 23 Jan 2025to 31 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 2 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Voluntary written informed consent obtained from the participant (or legal guardian) with good compliance expected throughout the study.
- All of the following conditions must be met:
- Age 2-75 years at informed consent; both sexes eligible. For minors (≤18 years), consent must be provided by a parent/legal guardian; minors able to sign must co-sign with their guardian.
- Histologically confirmed B-cell lymphoma per the 2024 v3 NCCN Clinical Practice Guidelines in Oncology: B-Cell Lymphomas.
- Prior therapy requirements:
- Failure to achieve PR after first-line therapy, OR relapse within 12 months after first-line therapy; or Relapsed/refractory after second-line therapy (one standard chemo-regimen + one salvage regimen).
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- Prior regimens must have included anti-CD20 monoclonal antibody (unless documented CD20-negative tumor) and an anthracycline-containing regimen. In addition, at least one of the following must apply:
- Ineligible for autologous hematopoietic stem-cell transplantation (ASCT); ii. Refusal of ASCT; iii. Relapse after ASCT. d) Disease status at screening:
- Relapse: progression after prior PR or CR.
- Refractory: i. PD during/after last therapy, or best response ≤SD lasting <6 months; OR ii. Relapse or progression after ASCT (biopsy-proven), including relapse/PD ≤12 months post-ASCT or lack of response (SD/PD) to salvage therapy after ASCT.
- Tumor tissue (archival or fresh) positive for CD19 by IHC; pathology report within 6 months preferred.
- ≥1 measurable lesion per Lugano 2014 response criteria.
- ECOG performance status 0-3.
- Adequate marrow reserve: ALC ≥0.3 × 10⁹/L; PLT ≥30 × 10⁹/L (transfusion permitted).
- Adequate organ function:
- AST ≤3×ULN (≤5×ULN if tumor-related); ALT ≤3×ULN (≤5×ULN if tumor-related);• Total bilirubin ≤2×ULN (≤3×ULN with direct bilirubin ≤1.5×ULN for Gilbert's syndrome);• Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min (Cockcroft-Gault);• Pulmonary: ≤Grade 1 dyspnea and SpO₂ >91 % on room air;• LVEF ≥50 % by echocardiography;• INR ≤1.5×ULN and APTT ≤1.5×ULN.
- Women of child-bearing potential: negative serum/urine pregnancy test within 7 days before CAR-T infusion. All participants with reproductive potential must use effective contraception from screening through ≥12 months after CAR-T infusion.
- Adequate venous access for leukapheresis or repeated phlebotomy, with no contraindications to leukapheresis.
- Estimated life expectancy >3 months.
Who cannot join
- Concurrent malignancy other than the study indication, except for carcinoma in situ or any malignancy with a disease-free interval ≥3 years.
- Presence of any of the following:• Positive HBe-Ab and/or HBc-Ab with HBV-DNA above the lower limit of quantification;• Positive HCV-Ab with HCV-RNA above the lower limit of quantification;• Positive Treponema pallidum antibody (TP-Ab);• Positive HIV antibody.
- Active bacterial, fungal, viral, mycoplasmal, or other infection deemed uncontrollable by the investigator.
- History or current clinically significant CNS disorder unrelated to lymphoma-e.g., seizure disorder, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any CNS autoimmune disease-that the investigator considers uncontrolled.
- Within 12 months before informed consent: percutaneous coronary intervention (angioplasty or stent placement), NYHA Class III-IV congestive heart failure, myocardial infarction, unstable angina, or other clinically significant cardiac history judged by the investigator; or QTc >480 ms (Fridericia correction) or LVEF <50 % by echocardiography at screening.
- Known primary immunodeficiency.
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- History of severe immediate hypersensitivity to any study drug.
- Receipt of any live vaccine within 6 weeks before screening.
- Pregnant or breastfeeding women.
- Active autoimmune disease requiring systemic immunosuppressive therapy.
- Participation in any other interventional clinical trial within 30 days before signing informed consent.
- Any condition that, in the investigator's opinion, renders the subject unsuitable for study participation.
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
Tongji Hospital of Tongji University
Shanghai
Wenjun Zhang, Ph.D, 13918803148, zhangwenjun@tongji.edu.cn
About this study
Official title: A Single-arm, Open-label Clinical Study Evaluating the Efficacy and Safety of U01 (ssCART-19) in Patients With Relapsed or Refractory B-cell Lymphoma.
This is a single-arm, open-label clinical study evaluating the efficacy and safety of U01 (ssCART-19) in patients with relapsed or refractory B-cell lymphoma.
Read the detailed description
The primary objective of this study is to evaluate the efficacy and safety of CD19-targeted CAR-T cells engineered with an IL-6 silencing element in patients with relapsed or refractory B-cell lymphoma.
- Conditions
- B Cell Lymphoma
- Being tested
- ssCART-19
- Keywords
- CD19, ssCART-19
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ssCART-19Drug
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 |
|---|---|---|
| U01(ssCART-19) CAR-T cells | Experimental | CD19-targeted CAR-T cells engineered with an IL-6 silencing element Receives: Drug: ssCART-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse events after U01 CAR-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 ssCART-19
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 Partial Remission(PR)
Measured: 2 years post CAR T cell infusion
Duration of response (DOR)
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 U01 to the date of death due to any cause.
Measured: 2 years post CAR T cell infusion
Progression-free survival (PFS)
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
Secondary outcomes (4)
Pharmacokinetics of ssCART-19
Time at the maximal concentration(Tmax)
Measured: 2 years post CAR T cell infusion
Pharmacokinetics of ssCART-19
Area under the concentration-time curve(AUC)
Measured: 2 years post CAR T cell infusion
Pharmacokinetics of ssCART-19
The maximal concentration of peripheral blood (Cmax)
Measured: 2 years post CAR T cell infusion
Pharmacodynamics of ssCART-19
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start23 Jan 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- Wenjun Zhang, Ph.D., Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093073
- Sponsor's protocol ID
- U01
- Status last verified
- Sep 2025
- First submitted
- 21 Jul 2025
- Last updated
- 6 May 2026
- 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 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label Clinical Study Evaluating the Efficacy and Safety of U01 (ssCART-19) in Patients With Relapsed or Refractory B-cell Lymphoma.
- ClinicalTrials.gov ID
- NCT07093073
- Acronym / sponsor ID
- U01
- Conditions
- B Cell Lymphoma
- Keywords
- CD19, ssCART-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Unicar-Therapy Bio-medicine Technology Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 30 Jul 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 evaluating the efficacy and safety of U01 (ssCART-19) in patients with relapsed or refractory B-cell lymphoma.
Detailed description
The primary objective of this study is to evaluate the efficacy and safety of CD19-targeted CAR-T cells engineered with an IL-6 silencing element in patients with relapsed or refractory B-cell lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| U01(ssCART-19) CAR-T cells | Experimental | Drug: ssCART-19CD19-targeted CAR-T cells engineered with an IL-6 silencing element |
Who may qualify
- Ages
- 2 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- Voluntary written informed consent obtained from the participant (or legal guardian) with good compliance expected throughout the study.
- All of the following conditions must be met:
- Prior regimens must have included anti-CD20 monoclonal antibody (unless documented CD20-negative tumor) and an anthracycline-containing regimen. In addition, at least one of the following must apply:
- Tumor tissue (archival or fresh) positive for CD19 by IHC; pathology report within 6 months preferred.
- ≥1 measurable lesion per Lugano 2014 response criteria.
Key exclusion criteria (12 listed)
- Concurrent malignancy other than the study indication, except for carcinoma in situ or any malignancy with a disease-free interval ≥3 years.
- Presence of any of the following:• Positive HBe-Ab and/or HBc-Ab with HBV-DNA above the lower limit of quantification;• Positive HCV-Ab with HCV-RNA above the lower limit of quantification;• Positive Treponema pallidum antibody (TP-Ab);• Positive HIV antibody.
- Active bacterial, fungal, viral, mycoplasmal, or other infection deemed uncontrollable by the investigator.
- History or current clinically significant CNS disorder unrelated to lymphoma-e.g., seizure disorder, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any CNS autoimmune disease-that the investigator considers uncontrolled.
- Within 12 months before informed consent: percutaneous coronary intervention (angioplasty or stent placement), NYHA Class III-IV congestive heart failure, myocardial infarction, unstable angina, or other clinically significant cardiac history judged by the investigator; or QTc >480 ms (Fridericia correction) or LVEF <50 % by echocardiography at screening.
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 |
|---|---|---|
| ssCART-19Lymphodepletion 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 | U01(ssCART-19) CAR-T cells |
Primary outcome
Incidence of Adverse events after U01 CAR-T cells infusion [Safety and Tolerability]
Time frame: 28 days post administration of ssCART-19
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Objective Response Rate (ORR), as assessed by Investigators
Time frame: 2 years post CAR T cell infusion
The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Remission (CR) or Partial Remission(PR)
Duration of response (DOR)
Time frame: 2 years post CAR T cell infusion
Duration of response (DOR) is defined as the time from the first documented objective response to the first documented disease progression or death.
Overall survival (OS)
Time frame: 2 years post CAR T cell infusion
Overall Survival (OS) was defined as the time from the date of first infusion of U01 to the date of death due to any cause.
Progression-free survival (PFS)
Time frame: 2 years post CAR T cell infusion
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.
4 secondary outcomes
Pharmacokinetics of ssCART-19
Time frame: 2 years post CAR T cell infusion
Pharmacokinetics of ssCART-19
Time frame: 2 years post CAR T cell infusion
Pharmacokinetics of ssCART-19
Time frame: 2 years post CAR T cell infusion
Pharmacodynamics of ssCART-19
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 6 May 2026.
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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.
Wenjun Zhang, Ph.D. principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ssCART-19 in people with B Cell Lymphoma, 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 19 inclusion and 12 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 6 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 Wenjun Zhang, Ph.D (13918803148, zhangwenjun@tongji.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 U01 CAR-T cells infusion [Safety and Tolerability] (time frame: 28 days post administration of ssCART-19). The study lists 5 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 6 May 2026.