Immunotherapy With CD19 CAR T-cells for B-Cell Leukemia | NCT04100187

Studies
Immunotherapy With CD19 CAR T-cells for B-Cell Leukemia

NCT04100187

Sponsor

Kecellitics Biotech Company Ltd

Status

Unknown status

Last Update Posted

Dec 1, 2022Actual

Enrollment

100Estimated

Phase

Phase 1

Conditions

Leukemia

Interventions

Anti-CD19-CAR

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2023Estimated

Primary Completion Date

Aug 1, 2023Estimated

Completion Date

Aug 1, 2024Estimated

First Submitted Date

Sep 18, 2019

First Submission Date that Met QC Criteria

Sep 19, 2019

First Posted Date

Sep 24, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2022

Last Update Posted Date

Dec 1, 2022Actual

Name	Class
Hebei Yanda Ludaopei Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

This is a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product named CD19 Chimeric Antigen Receptor (CAR) T-cells (CD19 CAR T-cells) in patients with high risk, relapsed CD19+ Leukemia. Following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis for the generation of the CD19 CAR Tcells.

Patients will receive the CD19CAR T-cells following lymphodepleting chemotherapy. The study will evaluate the safety, efficacy and duration of response of the CD19 CAR T-cells in patients with high risk relapsed CD19+ Leukemia

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
experimental:3	Experimental	Leukemia treated with chimeric antigen receptor modified T cells(Anti-CD19-CAR) targeting CD19.	Biological: Anti-CD19-CAR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anti-CD19-CAR	Biological	Cells extracted, followed by induction chemotherapy before CD19-CAR infusion (dose escalation.)	experimental:3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events of each patient	Determine the toxicity profile of the CD19 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.	3 years
Survival time of Anti-CD19 CAR T cells in vivo	To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood.	3 years
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
Maximum tolerated dose (MTD) of CD19 targeted CAR T cells.	Maximum tolerated dose (MTD) of CD19 targeted CAR T cells.	4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Relapsed or refractory B cell Leukemia.
KPS>60.
Life expectancy>3 months.
Gender unlimited, age from 2 years to 70 years.
CD19 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

Exclusion Criteria:

KPS<50.
Patients are allergic to cytokines.
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Li xiangqun, DOCTOR	Contact	086-15712867910		xiangqun_li@doingtimes.com
Li xiangqun	Contact	086-15712867910		xiangqun_li@doingtimes.com

Overall Officials

Name	Affiliation	Role
Li xiangqun	Kecellitics Biotech Company Ltd	Study Chair

Locations

Not provided

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases