NCT04384393

Brief Summary

This is a study to evaluate the safety and clinical activity of ThisCART19 (Allogeneic CAR-T targeting CD19) in patients with refractory or relapsed CD19 positive B cell 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
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2020

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

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

May 6, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

May 9, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2022

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2023

Completed
Last Updated

January 11, 2022

Status Verified

December 1, 2021

Enrollment Period

2.5 years

First QC Date

May 6, 2020

Last Update Submit

December 20, 2021

Conditions

B Cell Malignancy

Outcome Measures

Primary Outcomes (3)

  • Incidence of Dose Limiting Toxicities

    To assess adverse events as dose limiting toxicities as defined by the protocol.

    From infusion to Day 28

  • Complete Remission

    Proportion of patients in whom with morphologic complete remission (CR)

    At Day 28 after ThisCART19 infusion

  • TRM: Treatment Related Mortality

    The mortality related with ThisCART19 infusion.

    Up to 2 years

Secondary Outcomes (4)

  • Objective Response Rate

    Up to 1 year

  • Duration of Response

    Up to 1 year

  • Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability

    From inclusion up to 1 year

  • Overall Survival Rate of 2 Years

    At year 2

Study Arms (1)

ThisCART19 cells injections

EXPERIMENTAL

In this study, allogeneic anti-CD19 CAR T Cells(ThisCART19 cells) is used to treat patients with refractory or relapsed CD19 positive B cell malignancies.

Biological: ThisCART19 cells

Interventions

ThisCART19 cellsBIOLOGICAL

0.2-60 x 10\^6 CAR T cells per kg body weight.

ThisCART19 cells injections

Eligibility Criteria

Age3 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with relapsed or refractory CD19 positive acute or chronic lymphocytic leukemia, or lymphoma.
  • No alternative treatment options deemed by investigator.
  • Measurable or detectble disease at time of enrollment.
  • Eastern cooperative oncology group (ECOG) performance status of ≤2.
  • Cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO).
  • Estimated life expectancy \> 12 weeks deemed by investigator.
  • Serum creatinine ≤1.6 mg/dl and/or blood urea nitrogen(BUN) ≤ 1.5 mg/dl .
  • Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 5 upper limit of normal (ULN).
  • Informed consent explained to, understood by and signed by patient/guardian.

You may not qualify if:

  • Pregnant or lactating women
  • Uncontrolled infection
  • Active hepatitis B virus or hepatitis C virus infection.
  • Patients who need steroids to control disease.
  • Patients who accepted autologous stem-cell transplantation (ASCT) within 100 days.
  • Patients with grade 2-4 graft-versus-host disease (GVHD), or deemed need to manage by investigator.
  • History of Human Immunodeficiency Virus (HIV) infection.
  • Patients with active central nervous system (CNS) involvement by malignancy.
  • Patients combine with other disease cause neutrophil count (ANC) \< 750 per microlitre or platelet count (PLT)\< 50,000 per microlitre.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

Hefei, Anhui, China

RECRUITING

Fundamenta Therapeutice Co.,Ltd

Suzhou, Jiangsu, China

RECRUITING

Study Officials

  • Xingbing Wang

    The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Li, Ph.D

CONTACT

+86-18662604088jli@ctigen.com

Ling He

CONTACT

+86-18626100886lhe@ctigen.com

Study Design

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

Study Record Dates

First Submitted

May 6, 2020

First Posted

May 12, 2020

Study Start

May 9, 2020

Primary Completion

November 10, 2022

Study Completion

October 24, 2023

Last Updated

January 11, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)