Clinical trial · Interventional
Efficacy and Safety Evaluation of IM19 CAR-T Cell Therapy for MRD+ After Transplantation
Efficacy Study About Donor Derived CD19-target T Cell to Treat B-ALL Post Hematopoietic Stem Cell Transplantation
NCT04336501CI-TRIAL-00048904unknownN/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)
Efficacy study about donor derived CD19-target T cell to treat B-ALL post hematopoietic stem cell transplantation
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 |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IM19 CAR-T | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IM19 CAR-T group
- description
- Subject will be treated with IM19 car-t cells
- interventionNames
- Biological: IM19 CAR-T
Primary outcomes (1)
- measure
- ORR at 6 month
- timeFrame
- 6 months
- description
- Objective response at 6 month
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * To be aged 3 to 65 years * It was consistent with the diagnosis of CD19+ B-All with MRD+ in allo- hsct transplantation * The immunotyping was determined to be CD19+ B-All * The T lymphocytes in the subjects were 100% donor T lymphocytes * No chemotherapy or antibody treatment was received 2 weeks before cell therapy * Left ventricular ejection fraction (LVEF) ≥50% and centerless inclusion were diagnosed by echocardiography * The subjects had no pulmonary active infection * Blood oxygen saturation at the fingertips ≥ 92% * Estimated survival of \>3 months * ECOG physical condition level 0\~1 Exclusion Criteria: * Unwilling to accept IM19 CAR-T cell therapy, do not agree to signInformed consent of subject * Subjects are allergic to the components of cellular products * Total serum bilirubin ≥ 2.0mg/dl、Serum albumin \< 35g/L、ALT and AST were more than 3 times of the upper limit of the normal range. Blood creatinine ≥ 2.0mg/dl;Platelet \< 20 x 109 / L * Subjects had activity level II-IV aGVHD, or activityModerate to severe cGVHD * The subjects had a severe failure to control the infection * Subject with known central nervous system leukemia (CNS2 or CNS3) * Subjects were treated with CAR T cells or DLT after transplantation * The subjects developed bone marrow failure syndrome after allo-hsct transplantation * The subjects had previously received other gene treatments * The subjects had a history of alcohol, drug use or mental illness * Subjects were enrolled in any other clinical investigator within 1 month prior to screening * Female subjects: 1) were pregnant/lactating, or 2) had a pregnancy plan during the study period,Or 3) fertile and unable to use effective contraception * The researchers believe there are other conditions that may not be appropriate for the study
References
Publications (0)
Data not yet available
No reference posted for this study.