NCT04260932

Brief Summary

This is a single center, single arm, open-label, phase I study to evaluate the safety and efficacy of CD19/CD20 Dual-CAR-T cells in patients with refractory and relapsed B-cell lymphoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

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

February 6, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 7, 2020

Completed
23 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2021

Completed
Last Updated

March 8, 2022

Status Verified

August 1, 2021

Enrollment Period

1.2 years

First QC Date

February 6, 2020

Last Update Submit

March 6, 2022

Conditions

B-cell Lymphoma

Outcome Measures

Primary Outcomes (2)

  • Percentage of participants with adverse events.

    6 months

  • Objective remission rate(ORR)

    The percentage of participants who achieved complete remission (CR) and partial remission over all participants.

    6 months

Secondary Outcomes (3)

  • Relapse-Free Survival(RFS )

    6 months

  • Overall-Survival(OS)

    6 months

  • Persistence of CAR-T cells in vivo

    6 months

Study Arms (1)

CD19/CD20 Dual-CAR-T cells

EXPERIMENTAL

CD19/CD20 Dual-CAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of CAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest for at least 2 days before infusion.

Biological: CD19/CD20 Dual-CAR-T cells

Interventions

CD19/CD20 Dual-CAR-T cellsBIOLOGICAL

CD19/CD20 Dual-CAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of CAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest at least for 2 days before infusion. CD19/CD20 Dual-CAR-T cells will be intravenously infused with a escalated dose of 1-6×106 cells/kg.

CD19/CD20 Dual-CAR-T cells

Eligibility Criteria

Age1 Year - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Relapsed and refractory B-cell lymphoma with:
  • Relapsed or refractory disease after ≥2 lines of chemotherapy including rituximab and anthracycline and either having failed after autologous or allogeneic hematopoietic stem cell transplantation (ASCT);
  • Patients must have evaluable evidence of disease, including minimal residual disease (MRD);
  • Double positive expression of CD19 / CD20 in B cells;
  • Ages 1 to 80 years, including boundary values;
  • ECOG score 0-3 points;
  • Women of childbearing age (15-49 years old) must receive a pregnancy test within 7 days prior to initiation of treatment and the results are negative; male and female patients with fertility must use an effective contraceptive to ensure 3 months after discontinuation of treatment during the study period not pregnant inside;
  • Patients who voluntarily sign informed consent and are willing to comply with treatment plans.

You may not qualify if:

  • patients with organ failure:
  • Heart: NYHA heart function grade IV;
  • Liver: Grade C that achieves Child-Turcotte liver function grading;
  • Kidney: kidney failure and uremia;
  • Lung: symptoms of respiratory failure;
  • Brain: a person with a disability;
  • Active infections that are difficult to control;
  • Human immunodeficiency virus (HIV) positive;
  • Liver and kidney function: total bilirubin \> 5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 5 × ULN, serum creatinine clearance rate 60mL / min;
  • GVHD ≥ 2 or anti-GVHD treatment;
  • intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation;
  • pregnant or lactating women;
  • The patient does not agree to use effective contraception during the treatment period and for the next 3 months;
  • Patients who participate in other clinical studies at the same time;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hebei Yanda Ludaopei Hospital

Sanhe, Hebei, 065200, China

Location

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

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

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

February 6, 2020

First Posted

February 7, 2020

Study Start

March 1, 2020

Primary Completion

May 10, 2021

Study Completion

September 10, 2021

Last Updated

March 8, 2022

Record last verified: 2021-08

Locations

CN(1)