Clinical Trial






A Phase I/II Study of CD19 CAR T-Cell Immunotherapy for CD19+ Recurrent/ Refractory Acute B Lymphocytic Leukemia (B-ALL) and B cell lymphoma


The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the CNDA. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.


Recruitment Status: Recruiting

See Contacts and Locations


Sponsor: Hebei Senlang BIOTECHNOLOGY Co., LTD

Information provided by (Responsible Party): Hebei Yanda Lu Daopei Hospital


Study Description

Brief Summary:
Patients with relapsed or refractory acute B Lymphocytic leukemia (B-ALL) and B cell lymphoma often develop resistance to chemotherapy. For this reason, the investigators are attempting to use T-cells obtained directly from the patient, which can be genetically modified to express a chimeric antigen receptor (CAR) to CD19, expressed on the surface of the cell in patients with CD19+ B-ALL and B cell lymphoma. The CAR enables the T-cell to recognize and kill the cell through the recognition of CD19, a protein expressed on the surface of the cell in patients with CD19+ leukemia and B cell lymphoma. This is a Phase I/II study designed to evaluate the safety and efficacy of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of CD19+ leukemia and B cell lymphoma.


Condition or disease 

Intervention/treatment 

Phase 

B-ALL and B cell lymphoma

Biological: Patient-derived CD19-specific CAR T-cells

Phase I/II


Study Design

Study Type:Interventional  (Clinical Trial)
Estimated Enrollment: 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Study of CD19 CAR T-Cell Immunotherapy for CD19+ Recurrent/ Refractory Acute B Lymphocytic Leukemia and B cell lymphoma
Actual Study Start Date: August 29,2017
Estimated Primary Completion Date: August 29,2019
Estimated Study Completion Date: August 29,2023


Arms and Interventions


Arm 

Intervention/treatment 

Experimental: Autologous and allogeneic CD19-specific CAR T-cells

Biological:

Patient-derived CD19-specific chimeric antigen receptor T-cells


Outcome Measures

Primary Outcome Measures:

1. The adverse events associated with one or multiple CAR T-cell product infusions will be assessed [ Time Frame: 30 days ]
The type, frequency, severity, and duration of adverse events will be summarized
2. Tumor load
Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.
[Time Frame: Up to 3 months]
3. CAR-T cell persistence
CAR-T cell persistence will be quantified with flow cytometry and qPCR
[Time Frame: Up to 3 months]


Eligibility Criteria

Ages Eligible for Study: 1 Year to 70 Years   (Child, Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers:No


Criteria*

• Inclusion Criteria

(The results of the examination after patients admitted in hospital are the mainly criteria for admission)
1. Be diagnosed a kind of Relapsed or Refractory CD19+ B-ALL and B cell lymphoma;
2. ECOG score≤2;
3. To be aged 1 to 70 years;
4. More than a month lifetime from the consent signing date.


• Exclusion Criteria

1. Serious cardiac insufficiency, left ventricular ejection fraction<50%;
2. Has a history of severe pulmonary function damaging;
3. Merging other progressing malignant tumor;
4. Merging uncontrolled infection;
5. Merging the metabolic diseases (except diabetes);
6. Merging severe autoimmune diseases or immunodeficiency disease;
7. Patients with active hepatitis B or hepatitis C;
8. Patients with HIV infection;
9. Has a history of serious allergies on Biological products (including antibiotics);
10. Has acute GvHD on allogeneic hematopoietic stem cell transplantation patients after stopping immunosuppressants a month;
11. Pregnancy or lactation women;
12. Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
* The Criteria is finally evaluated by Investigators.


Contacts and Locations

• Contacts

Vicky Gao   +86 18518229985   international_center@ludaopei.com


• Locations

Hebei, China

Hebei Yanda Lu Daopei Hospital              Recruiting

Sipulan Road, Yanjiao Economy and Technology Development Zone, Langfang City, 065201, People’s Republic of China


• Sponsors and Collaborators

Hebei Senlang Biotechnology Inc., Ltd.
Hebei Yanda Lu Daopei Hospital


Principal Investigator:

 Peihua Lu, PhD & MD

Hebei Yanda Ludaopei Hospital

Study Chair:

Peihua Lu, PhD & MD

Jianqiang Li,PhD & MD

Hebei Yanda Ludaopei HospitalHebei Senlang Biotechnology Inc., Ltd.



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