Clinical trial · Interventional
Clinical Trial of SL1904B CAR-T Cells for Relapsed or Refractory Non-Hodgkin Lymphoma
NCT04447547CI-TRIAL-00047401unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a study of patients with relapsed or refractory non-Hodgkin's lymphoma. To evaluate the safety and efficacy of SL1904B in patients with relapsed or refractory non-Hodgkin's lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD19 CAR-T | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SL1904B CAR-T
- description
- Patients will be treated with CD19 CAR-T cells
- interventionNames
- Biological: CD19 CAR-T
Primary outcomes (2)
- measure
- Safety: Incidence and severity of adverse events
- timeFrame
- First month post CAR-T cells infusion
- description
- To evaluate the possible adverse events occurred within first one month after SL1904B infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
- measure
- Efficacy: Overall Remission Rate (ORR)
- timeFrame
- 3 months post CAR-T cells infusion
- description
- Overall Remission Rate (ORR) including partial remission and complete remission rate after infusion of SL1904B
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Sign the informed consent form and be willing and able to comply with the visit, treatment regimen, laboratory examination and other requirements of the study as stipulated in the trial flow chart; 2. The diagnosis of patients with relapsed or refractory non-hodgkin lymphoma; 3. There should be at least one measurable tumor focus according to the RECIST version 1.1; 4. ECOG Scores: 0\~2; 5. The expression of CD19 on the tumor cells was reported as positive by either immunohistochemistry or flow cytometry; 6. Estimated survival time was longer than 3 months; 7. main organ functions shall meet the following requirements including: serum creatinine ≤1.5 times the upper limit of normal value (ULN); ALT ULN 2.5 or less; AST ULN 2.5 or less; Total bilirubin ≤ 1.5ULN; Left ventricular ejection fraction (LVEF) ≥45%; Hemoglobin ≥90g/L; Platelet count ≥50×109/L; absolute Neutrophil count (ANC) ≥1.0×109/L; Blood oxygen saturation \>92%； 8. Peripheral blood mononuclear immune cells must be collected at least 2 weeks after the last radiotherapy or systemic treatment. Exclusion Criteria: 1. Serious cardiac insufficiency； 2. Has a history of severe pulmonary function damaging; 3. With other tumors which is/are in advanced malignant and has/have systemic metastasis; 4. Merging the metabolic diseases (except diabetes); 5. Merging severe autoimmune diseases or immunodeficiency disease; 6. Patients with active hepatitis B or hepatitis C virus infection; 7. Patients with HIV infection or syphilis infection; 8. Has a history of serious allergies on Biological products (including antibiotics); 9. Participated in any other clinical drug trial for the last six months; 10. Being pregnant and lactating or having pregnancy within 12 months; 11. With other uncontrolled diseases and considered not suitable to participate by the researchers; 12. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.
References
Publications (0)
Data not yet available
No reference posted for this study.