Clinical trial · Interventional
Humanized CAR-T Therapy for Treatment of B Cell Malignancy
Humanized CAR-T Therapy for Treatment of Recurrent or Refractory B Cell Malignancy by Targeting CD19
NCT02782351CI-TRIAL-00028950unknownPhase 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)
The present study evaluates the safety and efficacy of humanized Chimeric antigen receptor T cells (CAR-T) in treating recurrent or refractory B cell malignancy targeting CD19 with a humanized scFv. All participants will receive autologous chimeric antigen receptor engineered T cells.
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, Lymphocytic, Chronic, B-Cell | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAR-T | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CAR-T
- description
- In interventional studies, patients enrolled will receive autologous 2nd generation CAR-T cells, which contain a humanized single chain antibody sequence against CD19.
- interventionNames
- Biological: CAR-T
Primary outcomes (1)
- measure
- CAR-T cells persistence in peripheral blood
- timeFrame
- 12 months
- description
- The presence of CAR T cells in patients' peripheral blood will be quantified with real time qPCR
Secondary outcomes (1)
- measure
- B cell number and immunoglobulins in peripheral blood
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
Show eligibility criteria text
Inclusion Criteria: * Age≥3 at the time of consent * Survival time\>12 weeks * B cell hematological malignancies by pathological examination * Chemotherapy failure or recurrent B cell malignancy * Creatinine\< 2.5mg/dl * Glutamic-pyruvic transaminase, glutamic oxalacetic transaminase\< 3 fold of normal level * Karnofsky Performance Status\>50% at the time of screening * Bilirubin\<2.0mg/dl * Adequate pulmonary, renal, hepatic, and cardiac function * Fail in autologous or allogenic haemopoietic stem cell transplantation * Free of leukocytes removal contraindications Exclusion Criteria: * Pregnant or nursing women * Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening * Previous treatment with any gene therapy product * Abnormal vital signs * Highly allergic constitution or history of severe allergies, especially allergy to interleukin-2 * General infection or local severe infection, or other infection that is not controlled * Dysfunction in lung, heart, kidney and brain. * Severe autoimmune diseases * other symptoms that are not applicable for CAR-T
References
Publications (4)
- BACKGROUNDvan der Stegen SJ, Hamieh M, Sadelain M. The pharmacology of second-generation chimeric antigen receptors. Nat Rev Drug Discov. 2015 Jul;14(7):499-509. doi: 10.1038/nrd4597. PMID 26129802
- RESULTDavila ML, Bouhassira DC, Park JH, Curran KJ, Smith EL, Pegram HJ, Brentjens R. Chimeric antigen receptors for the adoptive T cell therapy of hematologic malignancies. Int J Hematol. 2014 Apr;99(4):361-71. doi: 10.1007/s12185-013-1479-5. Epub 2013 Dec 6. PMID 24311149
- DERIVEDQi Y, Zhao M, Hu Y, Wang Y, Li P, Cao J, Shi M, Tan J, Zhang M, Xiao X, Xia J, Ma S, Qiao J, Yan Z, Li H, Pan B, Sang W, Li D, Li Z, Zhou J, Huang H, Liang A, Zheng J, Xu K. Efficacy and safety of CD19-specific CAR T cell-based therapy in B-cell acute lymphoblastic leukemia patients with CNSL. Blood. 2022 Jun 9;139(23):3376-3386. doi: 10.1182/blood.2021013733. PMID 35338773
- DERIVEDChen W, Ma Y, Shen Z, Chen H, Ma R, Yan D, Shi M, Wang X, Song X, Sun C, Cao J, Cheng H, Zhu F, Sun H, Li D, Li Z, Zheng J, Xu K, Sang W. Humanized Anti-CD19 CAR-T Cell Therapy and Sequential Allogeneic Hematopoietic Stem Cell Transplantation Achieved Long-Term Survival in Refractory and Relapsed B Lymphocytic Leukemia: A Retrospective Study of CAR-T Cell Therapy. Front Immunol. 2021 Oct 29;12:755549. doi: 10.3389/fimmu.2021.755549. eCollection 2021. PMID 34777367