CD7 CAR-T for Patients With r/r CD7+ Hematologic Malignan... | NCT05454241

Studies
CD7 CAR-T for Patients With r/r CD7+ Hematologic Malignancies

NCT05454241

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Status

Completed

Last Update Posted

Mar 13, 2025Actual

Enrollment

14Actual

Phase

Phase 2

Conditions

Hematological Malignancies

Interventions

Anti-CD7 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

Jun 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 7, 2022Actual

Primary Completion Date

Aug 31, 2024Actual

Completion Date

Aug 31, 2024Actual

First Submitted Date

Jul 4, 2022

First Submission Date that Met QC Criteria

Jul 8, 2022

First Posted Date

Jul 12, 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

Mar 11, 2025

Last Update Posted Date

Mar 13, 2025Actual

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 is a open-label, phase 2 study to evaluate the efficacy, safety and PK of CD7 chimeric antigen receptors treatment for patients with refractory/relapsed CD7 positive hematological malignancies.

Detailed Description

Not provided

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
anti-CD7 UCAR-T cells	Experimental		Drug: Anti-CD7 CAR-T

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anti-CD7 CAR-T	Drug	Universal CAR-T cells targeting CD7	anti-CD7 UCAR-T cells

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall Response Rate(ORR)	Number of patients who achieved response after treatment of CD7 CAR-T cell.	1 Year

Secondary Outcomes

Measure	Description	Time Frame
Duration of overall response (DOR)	Duration of overall response will be assessed from the CAR-T cell infusion to progression, death or last follow-up.	1 Year
Overall survival(OS)	OS will be assessed from the CAR-T cell infusion to death or last follow-up.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed CD7 positive relapsed/refractory hematological malignancies.
Echocardiography shows left ventricular ejection fraction (LVEF) ≥ 50%;
There is no active pulmonary infection, and the oxygen saturation during air inhalation is more than 92%;
The estimated survival time is more than 3 months;
Eastern cooperative oncology group (ECOG) performance status of 0 to 2
The patients or their legal guardians voluntarily participated in the trial and signed the informed consent.

Exclusion Criteria:

Patients with history of epilepsy or other central nervous system diseases;
Patients with prolonged QT or severe heart disease;
Pregnant or lactating women
Patients with uncontrolled active infection.
Positive for any of the following etiological tests: HIV, HBV, HCV
Any other conditions that researcher think it is inappropriate for the subject to anticipate the trial

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 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

Name	Affiliation	Role
Ying Wang, Dr.	Hematology Hospital, Chinese Academy of Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Hematology & Blood Diseases Hospital		Tianjin		300020	China

IPD Sharing Statement Module

Plan to Share IPD

Description

When the research is completed, it will be shared in the form of a paper publication

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019337	Hematologic Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided