Clinical trial · Interventional
C-CAR011 Treatment in Subjects With ALL After HSCT
A Study Evaluating Safety and Efficacy of CBM.CD19-targeted Chimeric Antigen Receptor T Cells (C-CAR011) Treatment in Subjects With Acute Lymphoblastic Leukemia(ALL) After Hematopoietic Stem Cell Transplantation(HSCT)
NCT03327285CI-TRIAL-00047444unknownN/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 single-center, prospective clinical study evaluating safety and efficacy of C-CAR011 treatment in subjects with ALL after HSCT
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 |
|---|---|---|---|
| Acute Lymphoblastic Leukemia(ALL) | Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| C-CAR011 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- C-CAR011
- description
- The amount of cells received:1.0-5.0×10\^6 CAR+T cells/kg
- interventionNames
- Biological: C-CAR011
Primary outcomes (2)
- measure
- TEAEs
- timeFrame
- 2 months
- description
- TEAEs evaluated after C-CAR011 infusion
- measure
- GVHD
- timeFrame
- 2 months
- description
- GVHD evaluated after C-CAR011 infusion
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Age 15-65 years old, male or female. * Volunteered to participate in this study and signed informed consent. * Meet the two populations above. * Histologically diagnosed as CD19+B-ALL. * 100% T lymphocytes of donor. * Treatment without chemotherapy and antibody therapy within 2 weeks prior to C-CAR011 therapy. * Left ventricular ejection fraction (LVEF) ≧ 50%, no evidence of pericardial effusion and clinically significant arrhythmias. * Baseline oxygen saturation ≧ 92% on room air and with normal pulmonary function, no evidence of active lung infection. * Expected survival ≧ 3 months. * Eastern cooperative oncology group (ECOG) performance status of 0 or 1. Exclusion Criteria: * History of allergy to cellular products. * Any kind of these laboratory testing: serum total bilirubin≧2.0mg/dl, serum albumin\<35g/L, ALT, AST≧3×ULN, serum creatinine≧2.0mg/ dl,platelets\<20×109/L. * The subjects had active aGVHD with II-IV degrees (Glucksberg degrees) or active moderate to severe cGVHD. * Severe uncontrolled infection (mycotic, bacterial, virus and so on). * Any central nervous system leukemia(CNS2, CNS3) , with insensitive to intrathecal injection of or radiotherapy of head/spine; but effectively controlled cases will be eligible. * The subjects were treated CART cells or DLI after HSCT. * Bone marrow failure syndrome(BMF) after allogeneic hematopoietic stem cell transplantation. * Any genetically modified T cell therapy. * History of heavy drinking, drug taking or mental disease. * Participated in any other clinical trial within one month prior to enrollment. * Women who are pregnant or lactating or have breeding intent in 6 months. * The investigators believe that any increase in the risk of the subject or interference with the results of the trial.
References
Publications (0)
Data not yet available
No reference posted for this study.