Clinical trial · Interventional
Assessment of Safety and Efficacy of ThisCART19A in Adult Patients With B-NHL After Failure of Autologous Chimeric Antigen Receptor T- Cell(CAR-T) Therapy
Assessment of Safety and Efficacy of ThisCART19A in Adult Patients With B Cells Non-Hodgkin's Lymphoma(B-NHL) After Failure of Autologous CAR-T Therapy
NCT05349266CI-TRIAL-00058073unknownPhase 1ClinicalTrials.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 phase I, single center study to assess the efficacy and safety of ThisCART19A in adult with Non-Hodgkins Lymphoma in China.
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 |
|---|---|---|---|
| ThisCART19A | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- ThisCART19A 2×10^6 cells/kg for dose level 1
- description
- Patients will receive 2×10\^6 cells/kg of ThisCART19A
- interventionNames
- Biological: ThisCART19A
- type
- EXPERIMENTAL
- label
- ThisCART19A 3×10^6 cells/kg as dose level 2
- description
- Patients will receive 3×10\^6 cells/kg of ThisCART19A
- interventionNames
- Biological: ThisCART19A
- type
- EXPERIMENTAL
- label
- Patients will receive 4×10^6 cells/kg as dose level 3
- description
- Patients will receive 4×10\^6 cells/kg of ThisCART19A
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Cellular or histopathological diagnosis of B-cell non-Hodgkin's lymphoma (B-NHL) includes: diffuse Large B-cell lymphoma (DLBCL), follicular lymphoma to DLBCL (tFL), follicular lymphatic (FL), Mantle cell lymphoma (MCL), primary Mediastinal Large B-cell lymphoma (PMBCL), etc. * Failing to autologous CAR-T therapy. * At least one available lesion to be assessed. * Good organ function during screening. * Should be confirmed Cluster of differentiation(CD)19 positive by biopsy for the patient who received target CD19 therapy before. Exclusion Criteria: * Allergic to preconditioning measures. * Patients with other malignancies other than B-cell malignancies within 5 years prior to screening. Patients with cured skin squamous carcinoma, basal carcinoma, non-primary invasive bladder cancer, localized low-risk prostate cancer, in situ cervical/breast cancer can be recruited. * Uncontrollable bacterial, fungal and viral infection during screening. * Patients had pulmonary embolism within 3 months prior to enrollment. * Had intolerant severe cardiovascular and cerebrovascular diseases and hereditary diseases prior to enrollment. * Imaging confirmed the presence of central nervous system involvement (both primary and secondary) and obvious symptoms at the time of screening. * Active hepatitis B virus (HBV) or hepatitis C virus (HCV) or Human immunodeficiency virus (HIV) or Syphilis infection. HBV-DNA \< 2000 IU/mL can be enrolled, but should admitted to use anti-virus drugs such as entecavir, tenofovir, etc, and supervisory the relative indication during the treatment. * Had big lesion(single lesion diameter ≥10 cm). * Bone marrow involvement≥5%. * Receive allogeneic hematopoietic stem cell transplantation less than 100 days. * Combined systemic steroid use (e.g., prednisone ≥20mg) within 3 days prior to screening. Or systemic diseases that require long-term use of immunization Inhibitor. * Vaccinated with influenza vaccine within 2 weeks prior to lymphodepleting chemotherapy (Severe Acute Respiratory Syndrome-Corona virus disease 19 can be included, inactivated, live/non-live adjuvant vaccinations allowed to be included) . * Patients who are receiving Graft versus host disease Hepatitis(GvHD) treatment; Patients without GvHD and who had stopped immunosuppressive drugs for at least 1 month were eligible for inclusion. * Women who are in pregnant or lactating, and female subjects or partners who plan to be pregnant within 1 year after cell infusion. Male subjects who plan pregnancy within 1 year after infusion.
References
Publications (0)
Data not yet available
No reference posted for this study.