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

NCT ID: NCT04850560

Last Updated: 2021-06-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-18
• Study Completion Date: 2024-05-01

Brief 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.

Conditions

Objective Response Rate

Study Design

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

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

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

Interventions

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

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hui Liu, MD, PhD

Role: CONTACT

sylenliu@zju.edu.cn

13819198629

Wenbin Qian, MD, PhD

Role: CONTACT

qianwb@zju.edu.cn

13605801032

Facility Contacts

Hui Liu

Role: primary

Other Identifiers

IR2021001123

Identifier Type: -

Identifier Source: org_study_id