Safety and Efficacy Evaluation of IM19 CAR-T Cells

Leukemia Clinical Trial

— IM19CAR-T  

Official title:

Safety and Efficacy Evaluation of IM19 CAR-T Cells on Refractory or Relapsed B-ALL Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03142646
• Other study ID #: 001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 30, 2016
• Est. completion date: October 1, 2018

Study information

• Verified date: October 2017
• Source: Beijing Immunochina Medical Science & Technology Co., Ltd.
• Contact: Xin-an Lu, Dr.
• Phone: 86-189-1157-6946
• Email: luxinan[@]immunochina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell leukemia or CD19+ B-all.

Description:

Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell leukemia or CD19+ B-ALL patients and determine the MTD,LTD and the best dosage.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with CD19+ leukemia, meeting the following criteria

• At least 2 prior combination chemotherapy regimens (not including single agent monoclonal antibody (Rituximab) therapy)

• Less than 1 year between last chemotherapy and progression

• Not eligible or appropriate for allo-HSCT

• To be aged 4 to 65 years

• Estimated survival of = 6 months, but = 2 years

• ECOG score =2

• Relapse after auto-HSCT

• Women of childbearing potential must have a urine pregnancy test taken and proven negative prior to the treatment. All patients agree to use reliable methods of contraception during the trial period and until follow-up for the last time.

• Voluntary participation in the clinical trials and sign the informed consent.

Exclusion Criteria:

• History of epilepsy or other CNS disease

• Patients have GVHD, which needs treatment with immunosuppressive agents

• Patients with prolonged QT interval or severe heart disease

• Patients in pregnancy or breast-feeding period

• Uncontrolled active infection

• Active hepatitis B or hepatitis C infection

• Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary

• Previously treatment with any gene therapy products

• Feasibility assessment during screening demonstrates <30% transduction of target lymphocytes, or insufficient expansion (<5-fold) in response to CD3/CD28 costimulation

• ALT /AST>3 x normal value; Creatinine> 2.5 mg/dl; Bilirubin >2.0 mg/dl

• Any uncontrolled medical disorders that the researchers consider are not eligible to participate the clinical trial

• HIV infection

• Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.

Related Conditions & MeSH terms

• Leukemia

Intervention

Biological:
• IM19 CAR-T
All patients will be treated with fludarabine and cyclophosphamide for 3 days,then,CAR-T cells expressing CD19 CAR will be infused 24-96 hours later.

Locations

Country	Name	City	State
China	Beijing hospital	Beijing
China	Peking University People's Hospital (PKUPH)	Peking

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Immunochina Medical Science & Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of study related adverse events	defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2.	2 years
Secondary	Overall response rate	An objective response is defined as: (1) a morphologic complete response (CR) or (2) a complete response with incomplete recovery of counts (CRi) (based on NCCN guidelines (National Comprehensive Cancer Network (NCCN), 2014) or (3) a negative minimal residual disease assessed by flow cytometry	2 years