NCT04156243

Brief Summary

This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD19 CARvac in patients with relapsed and/or refractory 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
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Feb 2018

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

Study Start

First participant enrolled

February 1, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
Last Updated

November 12, 2019

Status Verified

January 1, 2019

Enrollment Period

2.1 years

First QC Date

November 6, 2019

Last Update Submit

November 8, 2019

Conditions

B Cell LymphomaB Cell Leukemia

Keywords

CD19CD19 CAR T cell

Outcome Measures

Primary Outcomes (3)

  • Number of participants with dose limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

    28 days

  • Type of dose-limiting toxicity (DLT)

    28 days

  • Number of participants with adverse event by severity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

    2 years

Secondary Outcomes (3)

  • Overall Response Rate (ORR)

    1 year

  • Progression-free survival (PFS)

    1 year

  • Overall survival

    1 year

Study Arms (1)

CD19 CARvac T cells

EXPERIMENTAL

CD19 CARvac T cells transduced with a lentiviral vector to express

Biological: CD19 CARvac T cells

Interventions

CD19 CARvac T cellsBIOLOGICAL

CD19 CARvac T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy.

CD19 CARvac T cells

Eligibility Criteria

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

You may qualify if:

  • Diagnosis based on the World Health Organization (WHO) 2008
  • Patients have exhausted standard therapeutic options
  • Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks
  • Female must be not pregnant during the study

You may not qualify if:

  • Prior solid organ transplantation
  • Potentially curative therapy including chemotherapy or hematopoietic cell transplant
  • Prior treatment with BCMAxCD3 or CS1xCD3 bispecific agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The General Hospital of Western Theater Command

Chengdu, China

RECRUITING

Peking University Shenzhen Hospital

Shenzhen, China

RECRUITING

Related Publications (1)

  • Liu F, Sha S, Ma G, Su Y, Xiong Y, He G, Li Y, Hanes WM, Tse W. Treatment of CML-transformed B Cell Acute Lymphoblastic Leukemia (B-ALL) in Adults with Anti-CD19 Chimeric Antigen Receptor T Cell (CAR T) Therapy. Stem Cell Rev Rep. 2020 Dec;16(6):1356-1358. doi: 10.1007/s12015-020-10008-7. No abstract available.

    PMID: 32840736DERIVED

MeSH Terms

Conditions

Lymphoma, B-CellLeukemia, B-Cell

Condition Hierarchy (Ancestors)

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

Study Officials

  • Hongyu Zhang, MD, PhD

    Peking University Shenzhen Hospital

    PRINCIPAL INVESTIGATOR

  • Fang Liu, MD, PhD

    The General Hospital of Western Theater Command

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin Pinz

CONTACT

6315386218kevin.pinz@icellgene.com

Study Design

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

Study Record Dates

First Submitted

November 6, 2019

First Posted

November 7, 2019

Study Start

February 1, 2018

Primary Completion

February 28, 2020

Study Completion

February 28, 2020

Last Updated

November 12, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)