Clinical trial · Interventional
Immunotherapy Using Autologous T Cell-Engineered With CD19-specific Chimeric Antigen Receptor for the Treatment of Recurrent /Refractory B Cell Leukemia
A Clinical Study Using Autologous T Cell Engineered With Chimeric Antigen Receptor Targeting to CD19（Cluster of Differentiation Antigen 19) in Treating Patients With Recurrent /Refractory B Cell Leukemia
- 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)
Objectives: The purpose of this study is to evaluate the safety and prognosis of New Cluster of Differentiation Antigen 19-chimeric Antigen Receptor T (nCAR19-T) Cells in the treatment of recurrent/refractory B-cell tumor and the Optimal dosage of nCAR19-T cell therapy. Methods: This study designs a novel therapy using nCAR19-T. 20 patients will be enrolled. Cyclophosphamide 500 mg - 2000 mg/m2 (day 2) with or without Fludarabine 30 mg/m2 /day, 4 days (day-6,-5,-4,-3); nCAR19-T transfusion：day 0(5×10※5/kg，1×10※6/kg，3×10※6/kg). According to the National Cancer Institute (NCI) standard (CTCAE), they will be observed 24 weeks long. Follow-up survey after the clinical study: within 1 months, once a week; then once a month for 1 years; and then once a year, a total of 15 years.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent B-Cell Tumor | — | UNRESOLVED | — |
| Refractory B-Cell Tumor | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD19-specific chimeric antigen receptor | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CD19-specific chimeric antigen receptor
- description
- After pretreatment, cluster of differentiation antigen 19 (CD19)-specific chimeric antigen receptor will be transfused.
- interventionNames
- Biological: CD19-specific chimeric antigen receptor
Primary outcomes (1)
- measure
- Occurrence of adverse events and tumor response rate related to study drug
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years old, male or female 2. Karnofsky≥60% 3. At least 2 courses of chemotherapy were performed 4. Creatinine is less than 2.5mg/dL;alanine aminotransferase (ALT) / aspartate aminotransferase(AST) less than 3 times of the normal bilirubin is less than 3mg/dL 5. Adequate venous access, isolation, and white blood cell production without other taboos 6. Signed informed consent 7. Patients with fertility are willing to use contraceptive method. 8. At least two months after infusion of T cells Exclusion Criteria: 1. Need to use glucocorticoid therapy 2. Need immunotherapy 3. Creatinine \> 2.5mg/dL; ALT / AST \> 5 times of the normal; bilirubin \> 3mg/dL 4. Forced expiratory volume at one second (FEV1)\<2 L,diffusing capacity of the lung for carbon monoxide (DLCO)\<40% 5. congestive cardiac failure (III or IV, NYHA); Significant hypotension; Coronary heart disease Can not be controlled; DLCO\<40% 6. human immunodeficiency virus (HIV), hepatitis B virus (HBV),hepatitis C virus (HCV) patients 7. Had received gene therapy 8. Significant encephalopathy / new focal neurologic impairment 9. Blood culture positive or radiographic evidence of infection 10. Other drugs, or other biological treatment, chemotherapy or radiotherapy are performed within a month 11. The history of allergic reactions in cell therapy and cetuximab similar compounds.
References
Publications (14)
- BACKGROUNDGhorashian S, Pule M, Amrolia P. CD19 chimeric antigen receptor T cell therapy for haematological malignancies. Br J Haematol. 2015 May;169(4):463-78. doi: 10.1111/bjh.13340. Epub 2015 Mar 5. PMID 25753571
- BACKGROUNDMaude SL, Shpall EJ, Grupp SA. Chimeric antigen receptor T-cell therapy for ALL. Hematology Am Soc Hematol Educ Program. 2014 Dec 5;2014(1):559-64. doi: 10.1182/asheducation-2014.1.559. Epub 2014 Nov 18. PMID 25696911
- BACKGROUNDGrupp SA. Advances in T-cell therapy for ALL. Best Pract Res Clin Haematol. 2014 Sep-Dec;27(3-4):222-8. doi: 10.1016/j.beha.2014.10.014. Epub 2014 Oct 27. PMID 25455270
- BACKGROUNDLee DW, Kochenderfer JN, Stetler-Stevenson M, Cui YK, Delbrook C, Feldman SA, Fry TJ, Orentas R, Sabatino M, Shah NN, Steinberg SM, Stroncek D, Tschernia N, Yuan C, Zhang H, Zhang L, Rosenberg SA, Wayne AS, Mackall CL. T cells expressing CD19 chimeric antigen receptors for acute lymphoblastic leukaemia in children and young adults: a phase 1 dose-escalation trial. Lancet. 2015 Feb 7;385(9967):517-528. doi: 10.1016/S0140-6736(14)61403-3. Epub 2014 Oct 13. PMID 25319501
- BACKGROUNDMaude SL, Frey N, Shaw PA, Aplenc R, Barrett DM, Bunin NJ, Chew A, Gonzalez VE, Zheng Z, Lacey SF, Mahnke YD, Melenhorst JJ, Rheingold SR, Shen A, Teachey DT, Levine BL, June CH, Porter DL, Grupp SA. Chimeric antigen receptor T cells for sustained remissions in leukemia. N Engl J Med. 2014 Oct 16;371(16):1507-17. doi: 10.1056/NEJMoa1407222. PMID 25317870
- BACKGROUNDKochenderfer JN, Dudley ME, Kassim SH, Somerville RP, Carpenter RO, Stetler-Stevenson M, Yang JC, Phan GQ, Hughes MS, Sherry RM, Raffeld M, Feldman S, Lu L, Li YF, Ngo LT, Goy A, Feldman T, Spaner DE, Wang ML, Chen CC, Kranick SM, Nath A, Nathan DA, Morton KE, Toomey MA, Rosenberg SA. Chemotherapy-refractory diffuse large B-cell lymphoma and indolent B-cell malignancies can be effectively treated with autologous T cells expressing an anti-CD19 chimeric antigen receptor. J Clin Oncol. 2015 Feb 20;33(6):540-9. doi: 10.1200/JCO.2014.56.2025. Epub 2014 Aug 25.