Safety and Efficacy Study of SL1904B CAR-T Cells for Rela... | NCT04546893

Studies
Safety and Efficacy Study of SL1904B CAR-T Cells for Relapsed or Refractory B-Cell Acute Lymphocyte Leukemia

NCT04546893

Sponsor

Hebei Senlang Biotechnology Inc., Ltd.

Status

Unknown status

Last Update Posted

Sep 14, 2020Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

B-ALL

Interventions

CD19 CAR-T

Countries

China

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

Sep 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2020Actual

Primary Completion Date

Sep 1, 2022Estimated

Completion Date

Dec 1, 2022Estimated

First Submitted Date

Sep 4, 2020

First Submission Date that Met QC Criteria

Sep 4, 2020

First Posted Date

Sep 14, 2020Actual

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

Sep 4, 2020

Last Update Posted Date

Sep 14, 2020Actual

Name	Class
Hebei Yanda Ludaopei Hospital	OTHER
Beijing Lu Daopei Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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 is an open, single-arm, clinical study to evaluate efficacy and safety of anti CD19 CAR-T cell in the treatment of recurrent or refractory B-ALL

Detailed Description

The CARs consist of an anti-CD19 single-chain variable fragment（scFv） that was derived from the FMC63 mouse hybridoma, a portion of the human CD137（4-1BB） molecule, and the intracellular component of the human CD3ζ molecule. Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy.

The Main research objectives:

To evaluate the safety and efficacy of 1904B in patients with recurrent or refractory B-ALL

The Secondary research objectives:

To investigate the cytokinetic characteristics of 1904B in patients with recurrent or refractory B-ALL

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1904B CAR-T	Experimental	Patients will be treated with CD19 CAR-T cells	Biological: CD19 CAR-T

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CD19 CAR-T	Biological	Biological: CD19 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis;	1904B CAR-T

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety: Incidence and severity of adverse events	To evaluate the possible adverse events occurred within first one month after SL1904B infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity	First month post CAR-T cells infusion
Efficacy: Remission Rate	Remission Rate including complete remission(CR)、CR with incomplete blood count recovery(CRi)、No remission(NR)	3 months post CAR-T cells infusion

Secondary Outcomes

Measure	Description	Time Frame
Efficacy:duration of response (DOR)	duration of response (DOR)	24 months post CAR-T cells infusion
Efficacy: progression-free survival (PFS)	progression-free survival (PFS) time

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Sign the informed consent and be willing and able to comply with the visit, treatment regimen, laboratory examination and other requirements of the study as stipulated in the trial flow chart;
A definite diagnosis of B-cell Lymphocyte Leukemia, which meets any of the following criteria: Relapsed : a) relapsed within 12 months after first remission;Refractory: a) no remission after six weeks of induction therapy or no remission after two courses of induction therapy; b) relapsedafter CR for 2 or more times; c) The first relapse after chemotherapy and no remission after at least one salvage treatment; c) relapsed after hematopoietic stem cell transplantation;
ECOG Scores: 0~2
CD19 positivewere detected by immunohistochemistry or flow cytometry;
Estimated survival time>3 months;
Peripheral blood mononuclear immune cells must be collected at least 2 weeks after the last radiotherapy or systemic treatment.

Exclusion Criteria:

Serious cardiac insufficiency；
Has a history of severe pulmonary function damaging;
With other tumors which is/are in advanced malignant and has/have systemic metastasis;
Severe or persistent infection that cannot be effectively controlled；
Merging severe autoimmune diseases or immunodeficiency disease;
Patients with active hepatitis B or hepatitis C([HBVDNA+]or [HCVRNA+]);
Patients with HIV infection or syphilis infection;
Has a history of serious allergies on Biological products (including antibiotics);
Being pregnant and lactating or having pregnancy within 12 months;
Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Peihua Lu, PhD&MD	Contact	008618611636172		peihua_lu@126.com
Jianqiang Li, PhD&MD	Contact	008615511369555		limmune@gmail.com