Clinical trial · Interventional
Safety and Efficacy Evaluation of IM19 CAR-T Cells
Safety and Efficacy Evaluation of IM19 CAR-T Cells on Refractory or Relapsed B-ALL Patients
NCT03142646CI-TRIAL-00032740IM19CAR-TunknownPhase 1 / Phase 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)
Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell leukemia or CD19+ B-all.
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 CART
- description
- A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by a single infusion of IM19CART cells administered intravenously.
- interventionNames
- Biological: IM19 CAR-T
Primary outcomes (1)
- measure
- Occurrence of study related adverse events
- timeFrame
- 2 years
- description
- defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2.
Secondary outcomes (1)
- measure
- Overall response rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with CD19+ leukemia, meeting the following criteria * At least 2 prior combination chemotherapy regimens (not including single agent monoclonal antibody (Rituximab) therapy) * Less than 1 year between last chemotherapy and progression * Not eligible or appropriate for allo-HSCT * To be aged 4 to 65 years * Estimated survival of ≥ 6 months, but ≤ 2 years * ECOG score ≤2 * Relapse after auto-HSCT * Women of childbearing potential must have a urine pregnancy test taken and proven negative prior to the treatment. All patients agree to use reliable methods of contraception during the trial period and until follow-up for the last time. * Voluntary participation in the clinical trials and sign the informed consent. Exclusion Criteria: * History of epilepsy or other CNS disease * Patients have GVHD, which needs treatment with immunosuppressive agents * Patients with prolonged QT interval or severe heart disease * Patients in pregnancy or breast-feeding period * Uncontrolled active infection * Active hepatitis B or hepatitis C infection * Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary * Previously treatment with any gene therapy products * Feasibility assessment during screening demonstrates \<30% transduction of target lymphocytes, or insufficient expansion (\<5-fold) in response to CD3/CD28 costimulation * ALT /AST\>3 x normal value; Creatinine\> 2.5 mg/dl; Bilirubin \>2.0 mg/dl * Any uncontrolled medical disorders that the researchers consider are not eligible to participate the clinical trial * HIV infection * Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
References
Publications (0)
Data not yet available
No reference posted for this study.