Clinical trial · Interventional
CD19-targeted CAR-T Cell Therapy for MRD+ B-cell Malignancies After Autologous Stem Cell Transplantation
CD19-targeted CAR-T Cell Therapy for Minimal Residual Disease in B-cell Malignancies After Autologous Stem Cell Transplantation
NCT03564977CI-TRIAL-00033563unknownN/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)
The main purpose of this study is to explore the efficacy of CD19-targeted CAR-T cell therapy for minimal residual disease (MRD) in B-cell Malignancies after autologous stem cell transplantation.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, B-Cell | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Lymphoma, B-Cell | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
| Minimal Disease, Residual | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD19-targeted CAR-T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CD19-targeted CAR-T cells
- interventionNames
- Biological: CD19-targeted CAR-T cells
Primary outcomes (4)
- measure
- Objective response rate
- timeFrame
- 2 years
- measure
- Disease control rate
- timeFrame
- 2 years
- measure
- Overall survival
- timeFrame
- 2 years
- measure
- Progress-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Confirmed by pathological biopsy in patients with B-cell malignancies and treated by autologous stem cell transplantation. 2. Age 18 to 75 years old, both male and female; 3. Is expected to survive more than 3 months; 4. Physical condition is good: ECOG score≤2; 5. In group of four weeks before Canon imaging examination evaluation body tumor load, recommend line PET - CT examination. 6. General requirements autologous as basic, normal blood T lymphocytes in autologous count must \>= 0.2 x10\^9 / L; 7. No obvious abnormal heart, liver, kidney, no large wounds that haven't healed on the body; 8. Into groups to participate in voluntarily, good adherence, can cooperate test observation, childbearing age women must be 7 days before starting treatment expert pregnancy test and the results were negative, and signed a written informed consent form. Exclusion Criteria: 1. Organ failure, such as heart: Class III and IV; liver: to Child grading of liver function grade C; kidney: kidney failure and uremia stage; lung: symptoms of severe respiratory failure; brain: disorder of consciousness; 2. Existing serious acute infection, uncontrollable, or have fester sex and chronic infection, wound in delay no more; 3. Patients with significant graft versus host disease (GVHD) after organ transplant history or allogeneic hematopoietic stem cell transplantation; 4. Systemic autoimmune diseases or immunodeficiency disease, patients with allergic constitution; 5. Coagulation abnormalities and severe thrombosis; 6. Pregnancy and lactation women; 7. Any other chronic disease patients who have been treated with immune agents or hormone therapy; 8. Patients who have participated in other clinical trials or other clinical trials in the past 30 days; 9. The Investigator believe the patients should not participate in this experiment.
References
Publications (0)
Data not yet available
No reference posted for this study.