CAR-T Cells in the Treatment of Malignant Hematological T... | NCT05619861

Studies
CAR-T Cells in the Treatment of Malignant Hematological Tumors

NCT05619861

Sponsor

Hebei Senlang Biotechnology Inc., Ltd.

Status

Unknown status

Last Update Posted

Nov 17, 2022Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Lymphoma, B-Cell
Leukemia, B-cell
Leukemia, T-Cell
Multiple Myeloma

Interventions

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

Nov 2022

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

Apr 27, 2020Actual

Primary Completion Date

Jan 26, 2023Estimated

Completion Date

Dec 26, 2023Estimated

First Submitted Date

Nov 9, 2022

First Submission Date that Met QC Criteria

Nov 9, 2022

First Posted Date

Nov 17, 2022Actual

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 9, 2022

Last Update Posted Date

Nov 17, 2022Actual

Name	Class
Cangzhou People's 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

To evaluate the safety of autologous CAR-T cell injection in the treatment of recurrent and refractory hematopoietic and lymphoid tissue tumors

Detailed Description

Main research objective: To evaluate the safety of autologous CAR-T cell injection in the treatment of recurrent and refractory hematopoietic and lymphoid tissue tumors. Secondary research objective: To investigate the efficacy and cytodynamic characteristics of autologous CAR-T cell injection in the treatment of recurrent and refractory hematopoietic and lymphoid tissue tumors

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
CAR-T	Experimental	Autologous CAR-T cells, intravenous infusion, infusion dose 0.1-3 × 106CAR-T cells/kg	Biological: CAR-T

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CAR-T	Biological	Patients will receive CAR-T treatment	CAR-T

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety: Incidence and severity of adverse events	The incidence and severity of adverse events and adverse reactions from infusion to withdrawal or before the safety follow-up period	24 months post CAR-T cells infusion

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

With the consent of himself or the legal guardian and the signed informed consent, he is willing and able to comply with the planned visit, research and treatment, laboratory examination and other test procedures; Clinical Study of CAR-T Technique in the Treatment of Recurrent and Refractory Hematopoietic and Lymphatic Tumor
Patients with recurrent and refractory hematopoiesis and lymphoid tissue tumors determined by clinical diagnosis;
Age 14-70 (including boundary value), both male and female;
Subjects with a physical status of 0~2 in the American Eastern Oncology Collaboration Group (ECOG);
The results of treatment related antigens were positive;
The expected life span is more than 3 months from the date of signing the informed consent;

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cangzhou People's Hospital	Recruiting	Cangzhou	Hebei		China

Condition Browse Module

MeSH Terms

ID	Term
D016393	Lymphoma, B-Cell
D015448	Leukemia, B-Cell
D015458	Leukemia, T-Cell
D009101	Multiple Myeloma

Ancestor Terms

ID	Term
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided