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Tests treatment safety and results for B Cell Lymphoma
Official title Efficacy and Safety Evaluation of U01(ssCART-19) in B-Cell Lymphoma
ClinicalTrials.gov ID: NCT06987916
What this study is testing
What is ssCART-19?
ssCART-19 is an investigational medicine, being studied as a potential treatment for b cell lymphoma.
Also referred to as anti-CD19 CAR T with small hairpin RNA to silence the IL-6 gene.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 .
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 75
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- Uncontrolled infections (bacterial, fungal, viral, mycoplasmal, or others) as determined by the investigator;
- Clinically significant CNS diseases (current or history), including: Epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disorders...
- Cardiovascular exclusion criteria : Cardiac angioplasty/stent placement within 12 months prior to signing ICF ; NYHA Class II-IV congestive heart...
- Primary immunodeficiency ;
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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 .
- 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...
- Uncontrolled infections (bacterial, fungal, viral, mycoplasmal, or others) as determined by the investigator;
- Clinically significant CNS diseases (current or history), including: Epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disorders, or CNS-related autoimmune diseases , deemed uncontrolled by the...
- 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...
- 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 treatment clinical trial within 30 days prior to ICF signing ;
- Other conditions deemed ineligible by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.