NCT03271515

Brief Summary

This study aims to evaluate the safety, efficacy and duration of response of anti-CD19 anti-CD20 Bispecific Chimeric Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, relapsed CD19+ and CD20+ haematological malignancies.

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
20

participants targeted

Target at P25-P50 for phase_1 leukemia

Timeline
Completed

Started Mar 2021

Shorter than P25 for phase_1 leukemia

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

August 31, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 5, 2017

Completed
3.5 years until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

1 year

First QC Date

August 31, 2017

Last Update Submit

January 19, 2021

Conditions

LeukemiaLymphoma

Keywords

leukemialymphomaCAR-TbispecificCD20CD19

Outcome Measures

Primary Outcomes (1)

  • Antitumor Effects

    Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.

    Every 3 months post treatment up to 24 months

Secondary Outcomes (2)

  • Survival time of Anti-CD19 Anti-CD20 CAR T cells in vivo.

    3 years

  • Adverse events of each patient.

    3 years

Study Arms (2)

conventional therapy

NO INTERVENTION

patients accept conventional radioactive and chemical therapy.

anti-CD19 anti-CD20 Bispecific CAR-T

EXPERIMENTAL

patients accept transfusion of anti-CD19 anti-CD20 Bispecific CAR-T cells.

Biological: anti-CD19 anti-CD20 Bispecific CAR-T

Interventions

anti-CD19 anti-CD20 Bispecific CAR-TBIOLOGICAL

patients accept transfusion of anti-CD19 anti-CD20 Bispecific CAR-T cells.

anti-CD19 anti-CD20 Bispecific CAR-T

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Relapsed or refractory B cell derived acute lymphoblastic leukemia(ALL), chronic lymphoblastic leukemia(CLL) and non-hodgkin lymphoma.
  • KPS\>60.
  • Life expectancy\>3 months.
  • Gender unlimited, age from 18 years to 70 years.
  • CD19 or CD20 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry.
  • Patients who have failed at least one line of a standard treatment.
  • No serious mental disorder.
  • Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of \>94%, and adequate renal function(Cr≤133umol/L).
  • No other serious diseases(autoimmune disease, immunodeficiency etc.).
  • No other tumors.
  • Patients volunteer to participate in the research.
  • Patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to trial.

You may not qualify if:

  • KPS\<50.
  • Patients are allergic to cytokines.
  • Central nervous system leukemia within 28 days.
  • Uncontrolled active infection.
  • Acute or chronic GVHD.
  • Treated with T cell inhibitor.
  • Pregnancy and nursing females.
  • HIV/HBV/HCV Infection.
  • Other situations we think improper for the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hebei Yanda Ludaopei Hospital

Sanhe, Hebei, 065200, China

Location

MeSH Terms

Conditions

LeukemiaLymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • li gangyi

    Beijing Doing Biomedical Co., Ltd.

    STUDY CHAIR

Central Study Contacts

gai liyun

CONTACT

086-13269099630liyun_gai@doingtimes.com

li gangyi

CONTACT

086-13901106501gangyi_li@doingtimes.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2017

First Posted

September 5, 2017

Study Start

March 1, 2021

Primary Completion

March 1, 2022

Study Completion

March 1, 2023

Last Updated

January 20, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)