Clinical trial · Interventional
Safety and Efficacy Evaluation of IM19 CAR-T Cells (IM19CAR-T)
Safety and Efficacy Evaluation of IM19 CAR-T Cells On CD19+ Refractory or Relapsed B-ALL Patients
NCT03173417CI-TRIAL-00038714completedPhase 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.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fludarabine and cyclophosphamide | Drug | — | UNRESOLVED |
| IM19 CAR-T | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IM19 CART
- description
- All patients will be treated with fludarabine and cyclophosphamide for 3 days,then,CAR-T cells expressing CD19 CAR will be infused 24-96 hours later.
- interventionNames
- Biological: IM19 CAR-T
- Drug: fludarabine and cyclophosphamide
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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with CD19+ Refractory or Relapsed B-ALL(At least 2 prior combination chemotherapy regimens) 2. To be aged 3 to 75 years 3. Blast in blood ≤ 30% 4. ECOG score ≤2 5. 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. 6. Voluntary participation in the clinical trials and sign the informed consent. Exclusion Criteria: 1. Intracranial hypertension or unconsciousness 2. Respiratory failure 3. CD19 negative 4. Disseminated intravascular coagulation 5. ALT /AST\>3 x normal value; Creatinine\> 1.5 x normal value; Bilirubin \>2.0 x normal value 6. Hematosepsis or Uncontrolled active infection 7. Uncontrolled diabetes 8. Abalienation; 9. WHO Sscore \>3 10. Patients in pregnancy or breast-feeding period 11. Previously treatment with any gene therapy products 12. Any uncontrolled medical disorders that the researchers consider are not eligible to participate the clinical trial 13. Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
References
Publications (2)
- DERIVEDChen M, Fu M, Wang A, Wu X, Zhen J, Gong M, Zhang X, Yue G, Du Q, Zhao W, Zhao Y, Lu P, Wang H. Cytoplasmic CD79a is a promising biomarker for B lymphoblastic leukemia follow up post CD19 CAR-T therapy. Leuk Lymphoma. 2022 Feb;63(2):426-434. doi: 10.1080/10428194.2021.1980214. Epub 2021 Oct 21. PMID 34672246
- DERIVEDZhang X, Lu XA, Yang J, Zhang G, Li J, Song L, Su Y, Shi Y, Zhang M, He J, Song D, Lv F, Li W, Wu Y, Wang H, Liu H, Zhou X, He T, Lu P. Efficacy and safety of anti-CD19 CAR T-cell therapy in 110 patients with B-cell acute lymphoblastic leukemia with high-risk features. Blood Adv. 2020 May 26;4(10):2325-2338. doi: 10.1182/bloodadvances.2020001466. PMID 32453841