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

NCT ID: NCT02842138

Last Updated: 2019-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2019-08-31

Brief 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.

Conditions

B-cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CD19 CAR T cells

A standard dose escalation approach aimed to assess the safety and efficacy of autologous anti-CD19 CAR T cells will be applied.

Group Type: EXPERIMENTAL

autologous anti-CD19 CAR T cells

Intervention Type: BIOLOGICAL

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%).

Interventions

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%).

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marino Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Jun Zhu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jun Zhu, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

Peking University Cancer Hospital

Beijing, , China

Countries

China

References

Ying Z, Huang XF, Xiang X, Liu Y, Kang X, Song Y, Guo X, Liu H, Ding N, Zhang T, Duan P, Lin Y, Zheng W, Wang X, Lin N, Tu M, Xie Y, Zhang C, Liu W, Deng L, Gao S, Ping L, Wang X, Zhou N, Zhang J, Wang Y, Lin S, Mamuti M, Yu X, Fang L, Wang S, Song H, Wang G, Jones L, Zhu J, Chen SY. A safe and potent anti-CD19 CAR T cell therapy. Nat Med. 2019 Jun;25(6):947-953. doi: 10.1038/s41591-019-0421-7. Epub 2019 Apr 22.

Reference Type: DERIVED

PMID: 31011207 (View on PubMed)

Other Identifiers

2016YJZ12

Identifier Type: -

Identifier Source: org_study_id