Clinical trial · Interventional
Safety and Efficacy of ThisCART19 in Patients With Refractory or Relapsed B Cell Malignancies
A Study to Evaluate the Safety and Clinical Activity of Allogeneic Chimeric Antigen Receptor T Cells Targeting CD19 in Patients With Refractory or Relapsed B Cell Malignancies.
NCT04384393CI-TRIAL-00055904unknownPhase 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 study to evaluate the safety and clinical activity of ThisCART19 (Allogeneic CAR-T targeting CD19) in patients with refractory or relapsed CD19 positive B cell malignancies.
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 |
|---|---|---|---|
| B Cell Malignancy | B-Cell Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ThisCART19 cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ThisCART19 cells injections
- description
- In this study, allogeneic anti-CD19 CAR T Cells(ThisCART19 cells) is used to treat patients with refractory or relapsed CD19 positive B cell malignancies.
- interventionNames
- Biological: ThisCART19 cells
Primary outcomes (3)
- measure
- Incidence of Dose Limiting Toxicities
- timeFrame
- From infusion to Day 28
- description
- To assess adverse events as dose limiting toxicities as defined by the protocol.
- measure
- Complete Remission
- timeFrame
- At Day 28 after ThisCART19 infusion
- description
- Proportion of patients in whom with morphologic complete remission (CR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient with relapsed or refractory CD19 positive acute or chronic lymphocytic leukemia, or lymphoma. 2. No alternative treatment options deemed by investigator. 3. Measurable or detectble disease at time of enrollment. 4. Eastern cooperative oncology group (ECOG) performance status of ≤2. 5. Cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO). 6. Estimated life expectancy \> 12 weeks deemed by investigator. 7. Serum creatinine ≤1.6 mg/dl and/or blood urea nitrogen(BUN) ≤ 1.5 mg/dl . 8. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 5 upper limit of normal (ULN). 9. Informed consent explained to, understood by and signed by patient/guardian. Exclusion Criteria: 1. Pregnant or lactating women 2. Uncontrolled infection 3. Active hepatitis B virus or hepatitis C virus infection. 4. Patients who need steroids to control disease. 5. Patients who accepted autologous stem-cell transplantation (ASCT) within 100 days. 6. Patients with grade 2-4 graft-versus-host disease (GVHD), or deemed need to manage by investigator. 7. History of Human Immunodeficiency Virus (HIV) infection. 8. Patients with active central nervous system (CNS) involvement by malignancy. 9. Patients combine with other disease cause neutrophil count (ANC) \< 750 per microlitre or platelet count (PLT)\< 50,000 per microlitre.
References
Publications (0)
Data not yet available
No reference posted for this study.