NCT04850560

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2021

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2021

Completed
28 days until next milestone

Study Start

First participant enrolled

May 18, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

June 9, 2021

Status Verified

April 1, 2021

Enrollment Period

12 months

First QC Date

April 18, 2021

Last Update Submit

June 5, 2021

Conditions

Objective Response Rate

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

    Objective response rate of the combination

    3 months

Study Arms (1)

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

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

Interventions

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

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

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 3100019, China

RECRUITING

MeSH Terms

Interventions

Decitabine

Intervention Hierarchy (Ancestors)

AzacitidineAza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Central Study Contacts

Hui Liu, MD, PhD

CONTACT

13819198629sylenliu@zju.edu.cn

Wenbin Qian, MD, PhD

CONTACT

13605801032qianwb@zju.edu.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2021

First Posted

April 20, 2021

Study Start

May 18, 2021

Primary Completion

May 1, 2022

Study Completion

May 1, 2024

Last Updated

June 9, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)