NCT04163302

Brief Summary

This is a single center, non-randomized, open-label, phase 2 study to evaluate the efficacy and safety of CD19-PD1-CART cells therapy for patients with relapsed/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_2

Timeline
Completed

Started Jul 2019

Typical duration for phase_2

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

Study Start

First participant enrolled

July 7, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 14, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

November 15, 2019

Status Verified

November 1, 2019

Enrollment Period

2 years

First QC Date

November 12, 2019

Last Update Submit

November 14, 2019

Conditions

Lymphoma, B-Cell

Keywords

LymphomaChimeric antigen receptor T cellChimeric antigen receptorImmunotherapyPD-1CD19

Outcome Measures

Primary Outcomes (1)

  • Incidence of Treatment-related Adverse Events

    Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0).

    3 years

Secondary Outcomes (5)

  • Overall Remission Rate(ORR) of CD19-PD1-CART cells in Lymphoma

    3 years

  • Overall survival(OS) of CD19-PD1-CART cells in Lymphoma

    3 years

  • Progress-free survival(PFS) of CD19-PD1-CART cells in Lymphoma

    3 years

  • Rate of CD19-PD1-CARTcells in peripheral blood cells

    3 years

  • Quantity of CD19-PD1-CART cells copies in peripheral blood cells.

    3 years

Study Arms (1)

CD19+ Lymphoma

EXPERIMENTAL

This study is to evaluate the efficacy and safety of CD19-PD1-CART cells therapy for patients with Relapsed/Refractory B Cell Lymphoma.

Biological: CD19-PD1-CART Cell

Interventions

CD19-PD1-CART CellBIOLOGICAL

This study was a single-center, open-label, single-arm, non-randomized clinical trial, which has 3 groups by infusion dose level. Firstly, each dose group has 3 patients. The pretreatment regimen of cyclophosphamide (25mg/m2 for 3 consecutive days) and fludarabine (10mg/kg for 3 consecutive days) was given before CART cells were reinfused. CART cells were reinfused on the third day after the pretreatment. If no serious side effects emerges in the group, then the next group uses the subsequent higher dose. If serious side effects emerges in a single patients in any dose level, 3 more patients will be enrolled to the same dose level. After 9 or more patients, the investigators select the safest dose and recruit more patients for CART test to explore its effectiveness.

CD19+ Lymphoma

Eligibility Criteria

Age14 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, aged 14 to 80 years (including 14 and 80 years old).
  • The diagnosis was Refractory/relapsed B-cell lymphoma.(Meeting 1 of the first 4 items plus item 5)
  • A.Tumor shrinkage less than 50% or disease progression after 4 cycles of standard chemotherapy.
  • B.Achieved CR after standard chemotherapy, but relapsed within 6 months.
  • C.2 or more relapses after CR.
  • D.Not suitable for HSCT, or relapse after HSCT.
  • E.Subjects must have received adequate treatment in the past and the predicted survival is more than three months.
  • Patient or his or her legal guardian voluntarily participates in this stuy and signs an informed consent form.
  • Flow cytometry or immunohistochemistry showed CD19 positive in tumor cells.
  • No serious concomitant disease and major organ function is not serious abnormal.
  • ECOG physical condition score 0-3 or KPS score \> 80.
  • the test meets the following indicators:
  • A.ALT/AST \< 2.5 times the upper limit of normal (ULN) and total bilirubin≤34.2μmol/L.
  • B.Creatinine \< 176.8 μmol/L.
  • C.WBC≥2.5×109/L ，LY≥0.7×109/L，LY%≥15%.
  • +1 more criteria

You may not qualify if:

  • Women who are pregnant or breastfeeding.
  • Patients whose tumor cell don't have positive CD19 antigen.
  • Active hepatitis B or hepatitis C, HIV/AIDS infection, any uncontrolled active infection.
  • Patients who are using steroid drugs throughout the body currently.
  • Patients who have received any gene therapy in the past.
  • Patients who are allergy to immunotherapy and related drugs.
  • Patients with heavy heart disease or poorly controlled high blood pressure.
  • Patients who received chemotherapy or radiation 4 weeks before the study began.
  • Patients who are participating in other clinical trials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hai Nan Hospital of Chinese PLA General Hospital

Sanya, Hainan, 572000, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-CellLymphoma

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Quanshun Wang

    Hainan Hospital of Chinese PLA General Hospital

    STUDY CHAIR

  • Wengshuai Zheng

    Hainan Hospital of Chinese PLA General Hospital

    STUDY DIRECTOR

  • Lixun Guan

    Hainan Hospital of Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

  • Lu Wang

    Hainan Hospital of Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

  • Yuanyuan Xu

    Hainan Hospital of Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

  • Yalei Hu

    Hainan Hospital of Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

  • Zhengyang Gu

    Hainan Hospital of Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Quanshun Wang

CONTACT

15692538521wqs63@sohu.com

Wenshuai Zheng

CONTACT

1570157262818766179210@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This study was a single-center, open-label, single-arm, non-randomized clinical trial, which was divided in 3 groups by different infusion dose level. Firstly, each dose group has 3 patients. The pretreatment regimen of cyclophosphamide (25mg/m2 for 3 consecutive days) and fludarabine (10mg/kg for 3 consecutive days) was given before CART cells were reinfused. CART cells were reinfused on the third day after the pretreatment. If no serious side effects emerges in the group, then the next group uses the subsequent higher dose. If serious side effects emerges in a single patients in any dose level, 3 more patients will be enrolled to the same dose level. After 9 or more patients, the investigators select the safest dose and recruit more patients for CART test to explore its effectiveness.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Hematology Department of Hainan Hospital of PLA General Hospital; Vice Chief of Hematology Department of PLA General Hospital

Study Record Dates

First Submitted

November 12, 2019

First Posted

November 14, 2019

Study Start

July 7, 2019

Primary Completion

July 1, 2021

Study Completion

July 1, 2022

Last Updated

November 15, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)