Senl-h19 CAR-T Cell Injection in the Treatment of Patient... | NCT04792593

Studies
Senl-h19 CAR-T Cell Injection in the Treatment of Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

NCT04792593

Sponsor

Hebei Senlang Biotechnology Inc., Ltd.

Status

Unknown status

Last Update Posted

Mar 11, 2021Actual

Enrollment

15Estimated

Phase

Not Applicable

Conditions

B-ALL

Interventions

Senl-h19 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

Mar 2021

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

Dec 3, 2020Actual

Primary Completion Date

Dec 10, 2021Estimated

Completion Date

Feb 10, 2022Estimated

First Submitted Date

Mar 8, 2021

First Submission Date that Met QC Criteria

Mar 8, 2021

First Posted Date

Mar 11, 2021Actual

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

Mar 8, 2021

Last Update Posted Date

Mar 11, 2021Actual

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 study is an open, dose-escalating clinical study, taking patients with relapsed or refractory acute lymphoblastic leukemia as the test subjects, including mouse-derived CAR-T treatment failure or relapse, or for any reason cannot bridge the transplant r/r B-ALL.

Detailed Description

Main research objectives:

To evaluate the safety and efficacy of Senl-h19 CAR-T in patients with relapsed or refractory acute lymphoblastic leukemia Secondary research purpose To investigate the cytokinetic characteristics of Senl-h19 CAR-T in patients with relapsed or refractory acute lymphoblastic 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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Senl-h19 CAR-T	Experimental	Patients will be treated with Senl-h19 CAR-T cells	Biological: Senl-h19 CAR-T

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Senl-h19 CAR-T	Biological	Biological: Senl-h19 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis	Senl-h19 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 CD7 CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity	First 1 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
duration of response (DOR)	duration of response (DOR)	24 months post CAR-T cells infusion
progression-free survival (PFS)	progression-free survival (PFS) time

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. Sign the informed consent and be willing and able to comply with the visit, treatment protocol, laboratory examination, and other requirements of the study as specified in the study procedure sheet; 2. A definite diagnosis of relapsed and refractory acute B-lymphoblastic leukemia meets one of the following criteria: a) Mouse CAR-T treatment fails or relapses; B) Unable to bridge the graft for any reason; 3. Eastern Cooperative Oncology Group (ECOG) score ≤2; 4. Age ≥2 years old, male or female 5. CD19 positive tumor cells were detected by immunohistochemistry or flow cytometry; 6. Expected survival longer than 3 months; 7. The collection time of peripheral blood mononuclear immune cells must be at least 2 weeks from the last radiotherapy or systematic treatment of patients;

Exclusion Criteria:

1. Severe cardiac insufficiency; 2. Have a history of severe lung impairment; 3. Complicated with other advanced malignant tumors; 4. Complicated with severe or persistent infection that cannot be effectively controlled; 5. Complicated with severe autoimmune diseases or congenital immune deficiency; 6. Active hepatitis (HBVDNA or HCVRNA positive); Human immunodeficiency virus (HIV) infection or syphilis infection; 8. Have a history of severe allergy to biological products (including antibiotics); 9. The female patient is pregnant and lactating, or has a pregnancy plan within 12 months; 10. Conditions that the investigator believes may increase the risk to the subject or interfere with the outcome of the study.

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

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