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B Cell LymphomaPhase 1/2NCT06987916

Efficacy and Safety Evaluation of U01(ssCART-19) in B-Cell Lymphoma

A Phase 1/2 study testing ssCART-19 in people with B Cell Lymphoma, run by Shanghai Tongji Hospital, Tongji University School of Medicine at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is an open-label phase1 study to assess the safety and efficacy of U01(ssCART-19) cell therapy in the treatment of patients with refractory or recurrent 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
50 participants
Where
1 siteChina
Study dates
22 Apr 2025to 22 Apr 2030
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Participants must voluntarily sign the informed consent form (ICF) and demonstrate good compliance.
  • Participants must meet the following requirements:
  • Age ≥2 years and ≤75 years at the time of signing the ICF (both sexes eligible). For minors (<18 years), the legal guardian must sign after full disclosure; minors with decision-making capacity must co-sign with their guardians.
  • Confirmed diagnosis of B-cell lymphoma according to the NCCN Clinical Practice Guidelines for B-Cell Lymphomas (3rd Edition, 2024) .
  • Prior treatment requirements :
  • Failure to achieve partial response (PR) after first-line therapy, or relapse within 12 months post-first-line therapy; Relapsed/refractory B-cell lymphoma after second-line therapy (one standard chemotherapy regimen + one salvage regimen).
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  • Prior treatments must include CD20 monoclonal antibody (unless CD20-negative tumor confirmed by the investigator) and anthracycline-based regimens .
  • Additionally, meet one of the following:
  • Ineligible for autologous stem cell transplantation (ASCT); ii. Refusal of ASCT; iii. Post-ASCT relapse. d) Refractory/relapsed status at screening: Relapse: Disease progression (PD) after achieving PR or complete response (CR);
  • Refractory:
  • No response to last-line therapy (PD during/after treatment, or stable disease [SD] lasting <6 months); ii. Post-ASCT relapse/PD (biopsy-confirmed), including relapse/PD within 12 months post-ASCT with SD/PD after salvage therapy2.
  • CD19 positivity confirmed by immunohistochemistry (IHC) of tumor tissue (preferably within 6 months).
  • At least one measurable lesion assessed by the Lugano Lymphoma Response Criteria (Cheson 2014) .
  • ECOG performance status score 0-3 .
  • Adequate bone marrow reserve at screening:
  • Absolute lymphocyte count (ALC) ≥0.3×10⁹/L ; Platelet count (PLT) ≥30×10⁹/L .
  • Adequate organ function:
  • AST/ALT ≤3×ULN (≤5×ULN if due to tumor infiltration); Total bilirubin ≤2×ULN (≤3×ULN for Gilbert syndrome with direct bilirubin ≤1.5×ULN); Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min (Cockcroft-Gault formula); Oxygen saturation >91% on room air (dyspnea grade ≤1); Left ventricular ejection fraction (LVEF) ≥50% ; INR ≤1.5×ULN and APTT ≤1.5×ULN .
  • Negative pregnancy test (blood/urine) within 7 days before CAR-T infusion for women of childbearing potential. All participants must agree to use effective contraception during the study and for ≥1 year post-treatment.
  • Adequate venous access for leukapheresis or blood collection, with no contraindications to leukapheresis.
  • Expected survival ≥3 months .

Who cannot join

  • Concurrent malignancies , except for:
  • Malignancies with disease-free survival (DFS) >3 years ; Carcinoma in situ ;
  • Active viral infections :
  • Hepatitis B : Positive for HBe-Ab and/or HBc-Ab with HBV-DNA > lower limit of quantitation (LLOQ) ; Hepatitis C : Positive HCV-Ab with HCV-RNA > LLOQ ; Positive Treponema pallidum antibody (TP-Ab); Positive HIV antibody ;
  • Uncontrolled infections (bacterial, fungal, viral, mycoplasmal, or others) as determined by the investigator;
  • Clinically significant CNS diseases (current or history), including:
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  • Epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disorders, or CNS-related autoimmune diseases , deemed uncontrolled by the investigator;
  • Cardiovascular exclusion criteria :
  • Cardiac angioplasty/stent placement within 12 months prior to signing ICF ; NYHA Class II-IV congestive heart failure , myocardial infarction, unstable angina, or other clinically significant cardiac history; QTe interval ≥480 ms (Fridericia correction) or LVEF <50% at screening;
  • Primary immunodeficiency ;
  • Severe immediate hypersensitivity to any study drug;
  • Live vaccine administration within 6 weeks prior to screening ;
  • Pregnancy or lactation ;
  • Active autoimmune diseases ;
  • Participation in another interventional clinical trial within 30 days prior to ICF signing ;
  • Other conditions deemed ineligible by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wenjun Zhang, Doctor contact

+86 13918803148

zhangwenjun@tongji.edu.cn

China1 site, 1 recruiting

  • Shanghai Tongji Hospital ( Tongji Hospital of Tongji University)

    Shanghai, Shanghai Municipality, 200065

    Wenjun Zhang, Doctor, +86 13918803148, zhangwenjun@tongji.edu.cn

    Miao Xuan, doctor, 0862166111243

    Recruiting

Other trials in China

About this study

Official title: A Single-Arm, Open-Label Clinical Study on the Efficacy and Safety of U01 (ssCART-19) in the Treatment of Relapsed or Refractory B-Cell Lymphoma

This is an open-label phase1 study to assess the safety and efficacy of U01(ssCART-19) cell therapy in the treatment of patients with refractory or recurrent B-cell lymphoma .

Read the detailed description

Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) are critical complications in CAR T-cell therapy. Research highlights IL-6 as a central driver of CRS, as activated CAR T-cells secrete this cytokine, which in turn stimulates monocytes to produce additional IL-6. To mitigate this risk, ssCART-19-a modified anti-CD19 CAR T-cell therapy-incorporates small hairpin RNA (shRNA) technology to silence the IL-6 gene, thereby reducing IL-6 secretion by both CAR T-cells and monocytes. This study aims to assess the safety and efficacy of the U01 (ssCART-19) therapy in patients with refractory or recurrent B-cell lymphoma .

Conditions
B Cell Lymphoma
Being tested
ssCART-19
Keywords
ssCART-19, Relapsed or Refractory B-Cell Lymphma, IL-6
Medical subject headings
Lymphoma, B-Cell, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ssCART-19Biological

    Also called anti-CD19 CAR T with small hairpin RNA to silence the IL-6 gene

    autologous T cells transduced with a lentiviral vector containing anti-CD19 CAR and small hairpin RNA to silence the IL-6 gene

Study groups in NCT06987916
Study groupRoleWhat they receive
ssCART-19ExperimentalAll enrolled patients in this arm will receive ssCART-19
Receives: Biological: ssCART-19

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The types, frequency, and severity of treatment related adverse events

    After CAR-T cell infusion, we will observe the potential adverse events, especially Cytokine Release Syndrome(CRS) and neurotoxicity Using NCI Common Terminology Criteria for Adverse Events(CTCAE) V5.0

    Measured: Day1 to Week 4

  2. Objective response rate(ORR)

    Measured: At 1,3,6,9,12,18 and 24 months post-treatment follow up

  3. Duration of response (DOR)

    Measured: At 1,3,6,9,12,18 and 24 months post-treatment follow up

  4. Progression free survival(PFS)

    Measured: At 1,3,6,9,12,18 and 24 months post-treatment follow up

  5. Overall survival(OS)

    Measured: At 1,3,6,9,12,18 and 24 months post-treatment follow up

Secondary outcomes (2)

  1. Kinetics of CAR-T cells

    Use flow cytometry or qPCR to monitor the kinetics of CAR-T cells

    Measured: Day1 to Month 3

  2. Monitoring changes in IL-6, ferritin, and CRP in peripheral blood following CAR-T cell infusion

    Measured: Day1 to Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2025
  2. Study start22 Apr 2025
  3. Primary completion22 Apr 2028 (estimated)
  4. Study completion22 Apr 2030 (estimated)

Resources

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
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06987916
Sponsor's protocol ID
U01-01
Status last verified
May 2025
First submitted
15 May 2025
Last updated
5 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ssCART-19 in people with B Cell Lymphoma, run by Shanghai Tongji Hospital, Tongji University School of Medicine 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 21 inclusion and 16 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 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wenjun Zhang, Doctor (+86 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?

The types, frequency, and severity of treatment related adverse events (time frame: Day1 to Week 4). 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?

On the ClinicalTrials.gov record for NCT06987916.

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 5 Jun 2025.

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