Phase I Study of CD19-CAR-T2 Cells for Patients With Chemotherapy Resistant or Refractory CD19+ Acute Leukemia

Sponsor

Guangdong Provincial People's Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02822326

Collaborator

Chinese Academy of Sciences (Other), Guangdong Zhaotai InVivo Biomedicine Co. Ltd. (Other)

Enrollment

Location

Arm

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of chimeric antigen receptor 19 (CD19-CAR-T2 Cells) infusions in patients with chemotherapy resistant or refractory CD19+ acute Leukemia.

Condition or Disease	Intervention/Treatment	Phase
Acute Leukemia	Biological: CD19-CAR-T2 Cells	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

CD19-CAR-T2 Cells for Relapse/Refractory CD19 Positive Acute Leukemia-a Phase I Trial

Study Start Date :

Jan 1, 2016

Anticipated Primary Completion Date :

Sep 1, 2019

Anticipated Study Completion Date :

Sep 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CD19-CAR-T2 T Cells The subject's T cells will be modified to those which could identify and kill the tumor cells (CD19+ cells). These CD19-CAR-T2 T cells will be infused over 10-15 minutes on days Day 1, 2 and 3 tentatively according to the response to infusion.	Biological: CD19-CAR-T2 Cells

Arm

Intervention/Treatment

Experimental: CD19-CAR-T2 T Cells

The subject's T cells will be modified to those which could identify and kill the tumor cells (CD19+ cells). These CD19-CAR-T2 T cells will be infused over 10-15 minutes on days Day 1, 2 and 3 tentatively according to the response to infusion.

Biological: CD19-CAR-T2 Cells

Outcome Measures

Primary Outcome Measures

The maximum tolerated dose(MTD) of CD19 positive relapsed/ refractory acute leukimia treated wtih CD19-CAR-T2 cells [24 weeks]

Secondary Outcome Measures

Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment [12 months]
Adverse events and laboratory abnormalities (type, frequency and severity)
Overall Response Rate [12 months]
Overall Response Rate (ORR), which includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and CSF. The primary endpoint will be based on the IRC assessment. The local investigator's assessed results will be used for sensitivity analysis.

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient with relapsed and/or refractory CD19 positive B-cell acute leukemia
Eastern Cooperative Oncology Group (ECOG) performance status 《 3
ALT/ AST 《 3x normal
Bilirubin < 2.0 mg/dl
Creatinine < 2.5 mg/dl and less than 2.5x normal for age
LVEF》 45%
Accept white blood cell collection
Provide informed consent

Exclusion Criteria:

Previous treatment with investigational gene or cell therapy medicine products
Solitary extramedullary relapse
Active hepatitis B , hepatitis C or HIV infection
Uncontrolled active infection
Presence of grade 2-4 acute or extensive chronic GVHD
Active CNS involvement: epilepsy, paresis, aphasia, stroke, severe head trauma,
Dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, etc.
Any uncontrolled active medical disorder that would preclude participation as outlined.
Received non-diagnostic purposes major surgery within the past 4 weeks
Participated in any other clinical study within the past 4 weeks
Used murine biological products (except blinatumomab), unless it is proved no anti-mouse antibodies exist.
Pregnancy or breast-feeding women
Use of prohibited drugs:
Steroids: Therapeutic doses of steroids must be stopped > 72 hours prior to CD19-CAR-T2 Cells infusion
Allogeneic cellular therapy: Any donor lymphocyte infusions (DLI) must be completed > 4 weeks prior to CD19-CAR-T2 Cells infusion
GVHD therapies: Any drug used for GVHD must be stopped > 4 weeks prior to CD19-CAR-T2 Cells infusion
Chemotherapy: i. The following drugs must be stopped > 1 week prior to CTL019 infusion and should not be administered concomitantly or following lymphodepleting chemotherapy: hydroxyurea, vincristine, 6-mercaptopurine, 6-thioguanine, methotrexate <25 mg/m2, cytosine arabinoside < 10 mg/m2/day, asparaginase; ii. The following drugs must be stopped > 4 weeks prior to CTL019 infusion: salvage chemotherapy (e.g. clofarabine, cytosine arabinoside > 100 mg/m2, anthracyclines, cyclophosphamide), excluding the required lymphodepleting chemotherapy drugs
Any situation that may increase the risk of the test or interfere with the test results

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guangdong General Hospital	Guangzhou	Guangdong	China	510080

Sponsors and Collaborators

Guangdong Provincial People's Hospital
Chinese Academy of Sciences
Guangdong Zhaotai InVivo Biomedicine Co. Ltd.

Investigators

Principal Investigator: Jianyu Weng, Dr., Guangdong Provincial People's Hospital
Principal Investigator: Peilong Lai, Dr., Guangdong Provincial People's Hospital