A Study to Assess CD19-targeted Immunotherapy T Cells in Patients With Relapsed or Refractory CD19+ B Cell Leukemia
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|ClinicalTrials.gov Identifier: NCT02672501|
Recruitment Status : Unknown
Verified February 2016 by Shanghai GeneChem Co., Ltd..
Recruitment status was: Recruiting
First Posted : February 3, 2016
Last Update Posted : February 3, 2016
In the conventional treatment options, B cell leukemia could be treated with chemotherapy drugs or HSCT. But chemotherapy could barely cured leukemia. And HSCT is often limited by lacking of HLA-matched donors, even if those patients who received HSCT still could be relapsed. And now, chimeric antigen receptor modified T cell infusion maybe an effective treatment to solve these problems. The investigators use a 2nd CAR- T with the optimized hinge and transmembrane domain to treat patients with relapsed or refractory B cell leukemia, including relapsed cases after HSCT. The purpose of this study is to assess the safety and efficacy of this 2nd CAR-T cells. At the same time, evaluating the possible and clinical responses of using donor-derived T cells engineered CAR-T cells.
Detailed Description: This study is being conducted to assess anti-CD19-CAR-T cells safety and efficacy in treating patients with B cell leukemia. The investigators constructed a 2nd CAR, CD19 as target protein, 4-1BB as co-stimulator. And optimized the spatial conformation by a suitable hinge & transmembrane domain sequences. The source of T cells for CAR-T is from two aspects, one is autologous, the other is donor-derived (only suitable for patients received HSCT before and relapsed). The infusion dose is (1-5)×106 CAR positive T cells/kg, and the specific cells numbers depend on the situation of individual CAR-T cells preparation.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, B-Cell||Drug: anti-CD19-CAR-T cells||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-labeled, Uncontrolled, Single-arm Pilot Study to Evaluate Cellular Immunotherapy Using CD19-targeted Chimeric Antigen Receptor Engineered T Cells in Patients With Relapsed or Refractory CD19+ B Cell Leukemia|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||December 2019|
Experimental: anti-CD19-CAR-T cells
patients receive chemotherapy(CF, cyclophosphamide and Fludarabine) on day -6 to day -1, then infusied with anti-CD19-CAR-T cells transduced with lentivirus on day 0 in the absence of disease progression or unacceptable toxicity.
Drug: anti-CD19-CAR-T cells
a 2nd CAR, CD19 as target protein, 4-1BB as co- stimulator, and optimized the spatial conformation by a suitable hinge & transmembrane domain sequences
Other Name: 2nd CAR-T
- Number of patients with adverse event [ Time Frame: 6 weeks ]asverse event is evaluated with CTCAE, version 4.0
- Number of patients with tumor response [ Time Frame: 8 weeks ]summarize tumor response by overal response rates
- Detection of transferred T cells in the circulation using quantitative -PCR [ Time Frame: 6 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672501
|Contact: Jianmin Yang, Doctoremail@example.com|
|Contact: Xuejun Yu, Masterfirstname.lastname@example.org|
|Shanghai Changhai Hospital，The Second Military Medical University||Recruiting|
|Shanghai, Shanghai, China, 200090|
|Contact: Jianmin Yang, Doctor 18317172636 email@example.com|
|Principal Investigator:||Jianmin Yang, Doctor||Shanghai Changhai Hospital，The Second Military Medical University|