A Clinical Research of CAR T Cells Targeting CD19 Positive Malignant B-cell Derived Leukemia and Lymphoma

Lymphoma Clinical Trial

Official title:

A Clinical Research of Chimeric Antigen Receptor (CAR) T Cells Targeting CD19 Positive Malignant B-cell Derived Leukemia and Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02349698
• Other study ID #: TMMU-BTC-001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 2014
• Est. completion date: December 2023

Study information

• Verified date: June 2019
• Source: Southwest Hospital, China
• Contact: Cheng Qian, MD,PhD
• Phone: 0086-023-68765461
• Email: cqian3184[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this research is to verify the safety of CD19 targeted chimeric antigen receptor T cells and to determine the proper dosage of CAR T cells infused.

Description:

Nowadays refractory or relapsed leukemia/lymphoma lacks effective treatment. Innovative therapy is urgently required. Chimeric antigen receptor (CAR)-modified T cells have demonstrated great successes in treating even late stage cluster of differentiation antigen 19 (CD19) positive B cell malignancies. To design better CAR T cells, we have developed new CD19 CARs. Preclinical studies have demonstrated effective killing of CD19 target cells. In this study, the CD19 CARs, will be evaluated in CD19 positive leukemia/lymphoma patients. The primary goal is to confirm its adverse effects including cytokine storm response and any other adverse effects. In addition, tumor targeting and disease status after treatment will also be evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Relapsed or refractory B cell derived acute lymphoblastic leukemia(ALL), chronic lymphocytic leukemia(CLL) and non-hodgkin lymphoma.

2. KPS>60.

3. Life expectancy>3 months.

4. Gender unlimited, age from 4 years to 75 years.

5. Disease progresses but reserves reaction to recent treatments.

6. Patients who have failed at least one line of a standard treatment.

7. No serious mental disorder.

8. Patients must have adequate cardiac function(no cardiac disease, LVEF=40% ), adequate pulmonary function as indicated by room air oxygen saturation of >94%, and adequate renal function(Cr=133umol/L).

9. No other serious diseases(autoimmune disease, immunodeficiency etc.).

10. No other tumors.

11. Patients volunteer to participate in the research.

Exclusion Criteria:

1. HIV affected.

2. Patients are allergic to cytokines.

3. Central nervous system leukemia within 28 days.

4. Uncontrolled active infection.

5. Acute or chronic GVHD.

6. Treated with T cell inhibitor.

7. Pregnancy and nursing females.

8. Other situations we think improper for the research.

Related Conditions & MeSH terms

• Leukemia
• Lymphoma

Intervention

Biological:
• Chimeric Antigen Receptor Modified T cells Targeting CD19
T cells modified with CD19 targeted chimeric antigen receptor.

Locations

Country	Name	City	State
China	Southwest Hospital of Third Millitary Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events of each patient.	Determine the toxicity profile of the CD19 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.	3 years
Secondary	Survival time of Anti-CD19 CAR T cells in vivo.	To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood.	3 years
Secondary	Efficacy of anti-CD19 CAR T cells assessed by the ability of CAR T cells to kill leukemia/lymphoma cells		12 weeks
Secondary	Maximum tolerated dose (MTD) of CD19 targeted CAR T cells.	To confirm the maximum tolerated dose of CD19 targeted CAR T cells.	4 weeks