Sequential Low-dose Decitabine With PD-1/CD28 CD19 CAR-T in Relapsed or Refractory B-cell Lymphoma

Objective Response Rate Clinical Trial

Official title:

Sequential Low-dose Decitabine Therapy With Novel CAR-T Carrying PD-1/CD28 Chimeric Switch Receptor in Relapsed or Refractory B-cell Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04850560
• Other study ID #: IR2021001123
• Status: Recruiting
• Phase: Phase 1
• Start date: May 18, 2021
• Est. completion date: May 1, 2024

Study information

• Verified date: April 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Hui Liu, MD, PhD
• Phone: 13819198629
• Email: sylenliu[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy and safety of CD19 PD-1/CD28-CAR-T sequential low-dose decitabine in the treatment of relapse or refractory B cell lymphoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• (1) Age = 18, upper limit 75, unlimited for men and women;

(2) ECOG score 0-3;

(3) Histologically confirmed diffuse large B-cell lymphoma (DLBCL) [according to who 2008];

(4) CD19 was positive (immunohistochemistry or flow cytometry).

(5) The definition of refractory or relapse of DLBCL is: no complete remission after 2-line treatment; disease progression in any treatment process, or disease stabilization time equal to or less than 6 months; or disease progression or relapse within 12 months after hematopoietic stem cell transplantation;

(6) The previous treatment of diffuse large B cell lymphoma must include rituximab (CD20 mAb) and anthracycline;

(7) There should be at least one measurable focus. It is required that any length of lymph node focus should be greater than 1.5cm or any length of extranodal focus should be greater than 1.0cm. PET-CT scan focuses should have uptake (SUV is greater than liver blood pool);

(8) The absolute value of neutrophils in peripheral blood = 1000 / µ L, platelet = 45000 / µ L;

(9) Heart, liver and kidney function: creatinine < 1.5mg/dl; ALT (alanine aminotransferase) / AST (aspartate aminotransferase) 2.5 times lower than the normal upper limit; total bilirubin < 1.5mg/dl; heart ejection fraction (EF) = 50%;

(10) Sufficient understanding ability and voluntary signing of informed consent;

(11) Those with fertility must be willing to use contraceptive methods;

(12) According to the judgment of the researchers, the expected survival time is more than 4 months;

(13) Willing to follow visit schedule, administration plan, laboratory inspection and other test steps.

Exclusion Criteria:

• (1) History of other tumors;

(2) Hematopoietic stem cell transplantation was performed within 6 weeks;

(3) Any target car-t treatment was performed within 3 months before the car-t treatment;

(4) Previous use of any commercially available PD-1 mAb;

(5) Cytotoxic drugs, glucocorticoids and other targeted drugs were received within 2 weeks before cell collection;

(6) Active autoimmune diseases;

(7) Uncontrollable infection of active bacteria and fungi;

(8) HIV infection, syphilis infection; active hepatitis B or C: hepatitis B: HBV-DNA = 1000IU / ml; hepatitis C: HCV RNA positive and liver function abnormal.

(9) Known central nervous system lymphoma.

Related Conditions & MeSH terms

• Objective Response Rate

Intervention

Biological:
• CD19 PD-1/CD28 CAR-T Plus Low Dose Decitabine
CD19 PD-1/CD28 CAR-T Plus Low Dose Decitabine

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	Objective response rate of the combination	3 months