Clinical trial · Interventional
To Evaluate Safety and Efficacy of Autologous CD19 Chimeric Antigen Receptor (CAR)-T Cells in Relapsed/Refractory B- Non-Hodgkin Lymphoma (B-NHL)
A Phase II Open Label Single-arm Study to Evaluate Safety and Efficacy of Autologous CD19 CAR-T Cells in Patients With Relapsed/Refractory B- Non-Hodgkin Lymphoma
NCT06698484CI-TRIAL-00082845CAR-T for NHLrecruitingPhase 2ClinicalTrials.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)
A Phase II Open-Label Single-arm Study to Evaluate Safety and Efficacy of locally manufactured autologous CD19-directed CAR T-cells in Patients with Relapsed/Refractory B- Non-Hodgkin Lymphoma (B-NHL) or patients not eligible for hematopoietic stem cell transplantation (HCT)
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 |
|---|---|---|---|
| Relapsed/Refractory B- Cell Non-Hodgkin Lymphoma | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAR-T cells | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patient will infuse with autologous CD19 CAR-T cells
- description
- CD19 CAR-T cells
- interventionNames
- Drug: CAR-T cells
Primary outcomes (1)
- measure
- Overall response rate (ORR)
- timeFrame
- From day 30, then 3 monthly until 24 months after infusion of CAR-T cells
- description
- The ORR is the sum of patients achieving complete response (CR) and partial response (PR) at day 30, then 3 monthly up to 24 months after receiving CAR T-cells determined by the investigator following Lugano criteria in non-Hodgkin Lymphoma (NHL). Response assessment will be determined using a PET CT scan, or other relevant imaging studies and compared to the baseline (pre-CAR-T infusion) study.
Secondary outcomes (2)
- measure
- overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 13 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically confirmed diagnosed with CD19 positive B cell NHL in accordance with WHO classification * Patients who are refractory to second-line treatment or patients who relapsed after first-line treatment with no available curative options such as autologous or allogeneic haematopoietic stem cell transplantation (HSCT) or relapse within one year of autologous HSCT * At least one measurable lesion according to revised IWG response criteria * Age between ≥13to ≤75 years * Adequate organ function as defined by a creatinine clearance \>40 ml/min, serum alanine transaminase (ALT) \< 5 times the normal value, serum bilirubin \< 3 times the normal value, left ventricular ejection fraction\> 45% * Absolute neutrophil count ≥ 1500/μl, haemoglobin level ≥ 7 g/dl, platelets ≥ 50000/μl. * Life expectancy \>12 weeks * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Female of childbearing age must have a negative pregnancy test and is on two effective contraception methods * Male patients must use two effective contraception methods Exclusion Criteria: * Active central nervous system (CNS) lymphoma (detected by Imaging study or cerebrospinal fluid (CSF) analysis) * Active cancer(other than NHL) or receiving cancer treatment * Evidence of severe lung, heart (New York Heart Association class III/IV, arrhythmia, heart block, uncontrolled hypertension), liver, or renal failure or severe neurologic disorder * Presence of active autoimmune disease requiring immunosuppressive therapy * Human Immunodeficiency Virus (HIV) positivity * Active Hepatitis B, and Hepatitis C infection * Uncontrolled infection * Pregnant/nursing female. * Receiving autologous or allogeneic stem cell transplant within 12 weeks of enrolment
References
Publications (0)
Data not yet available
No reference posted for this study.