Autologous CD19 CAR T Cells in Relapsed or Refractory B-cell Lymphoma

B-cell Lymphoma Clinical Trial

Official title:

A Safety and Efficacy Study of Autologous T Cells Engineered to Express Chimeric Antigen Receptor Targeting CD19 in Patients With Relapsed or Refractory B-cell Lymphoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02842138
• Other study ID #: 2016YJZ12
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: June 2016
• Est. completion date: August 2019

Study information

• Verified date: February 2019
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single arm, open-label, one center, dose escalation clinical study to determine the safety and efficacy of infusion of autologous T cells expressing CD19-redirected Chimeric Antigen Receptor (CD19 CAR T) in adult patients with relapsed or refractory CD19 positive B-cell lymphoma.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: August 2019
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. CD19+ B cell lymphoma,verified by IHC or flow cytometry.

2. a prior history of at least two standard care of medication.

3. ineligible for allogeneic transplantation or relapsed after transplantation.

4. patients are 18 years older.

5. life expectancy > 3months.

6. ECOG = 2.

7. satisfactory major organ functions: adequate heart function with LVEF=50%; pulse oximetry of = 90%; cockcroft-gault creatinine clearance=40 ml/min; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =3ULN; Bilirubin =2.0 mg/dl .

8. Blood: Hgb = 80 g/L, ANC = 1×10^9/L, PLT = 50×10^9/L.

9. women of reproductive potential must have a negative pregnancy test. Male and female of reproductive potential must agree to use birth control during the study and one year post study.

10. measurable tumors.

Exclusion Criteria:

1. using immunosuppressive drugs or systemic steroids within one week of enrollment.

2. active infection.

3. HIV positive.

4. active hepatitis B virus infection or hepatitis C virus infection.

5. breastfeeding or pregnant women.

6. patients refuse to practice birth control during study and one year post study.

7. patients with a prior history of other malignances will be excluded from this study, but patients who have been cured from skin basal cell carcinoma or cervical cancer, or who have had their tumors removed by surgical resection but without further therapies and have more than 5 years of progression-free survival, can be included into the study.

8. currently enrolled in other study.

9. patients, in the opinion of investigators, may not be eligible or are not able to comply with the study.

Related Conditions & MeSH terms

• B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell

Intervention

Biological:
• autologous anti-CD19 CAR T cells
Patients will receive a three-day regimen of chemotherapy consisting of fludarabine and cyclophosphamide aimed to deplete the lymphocytes. Four days after lymphodepletion, patients are intravenously infused autologous anti-CD19 CAR T cells. A prescribed CAR T cell dose will be intravenously infused to patient in a three-day split-dose regimen (day0,30%; day1, 30%; day2, 40%).

Locations

Country	Name	City	State
China	Peking University Cancer Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University	Marino Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Persistence of CAR T cells in patients		2 years
Primary	Number of patients with adverse events		2 years
Secondary	Treatment response rate of anti-CD19 CAR T cell infusion	Defined as the proportion of patients who achieved complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD) based on standardized response criteria for malignant lymphoma (Cheson BD, JCO, 2007).	4 weeks
Secondary	overall survival rate of patients treated with anti-CD19 CAR T cells		2 years
Secondary	progression-free survival of patients treated with anti-CD19 CAR T cells		2 years