NCT05995028

Brief Summary

The purpose of this clinical trial is to assess the feasibility, safety and efficacy of universal CAR T cells based on 4SCAR7U design against CD7-positive hematological malignancies using CD7 specific universal CAR T cells. The study also aims to learn more about the function of CD7 targeting CAR T cells and their persistence in patients of hematological malignancies.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
8mo left

Started Oct 2023

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress79%
Oct 2023Dec 2026

First Submitted

Initial submission to the registry

August 8, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 16, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

October 31, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

2.9 years

First QC Date

August 8, 2023

Last Update Submit

April 21, 2026

Conditions

T-cell Acute Lymphoblastic LymphomaAcute Myeloid LeukemiaNK Cell LymphomaT-cell Acute Lymphoblastic Leukemia

Keywords

T-ALLTCLAMLNK lymphomaUniversal CAR TCD7

Outcome Measures

Primary Outcomes (1)

  • Safety of infusion

    Treatment-related adverse events are assessed by NCI CTCAE V4.0 criteria.

    6 months

Secondary Outcomes (1)

  • Clinical response

    1 year

Study Arms (1)

Universal 4SCAR7U cells to treat CD7-positive hematological malignancies

EXPERIMENTAL
Biological: Universal CD7-specific CAR gene-engineered T cells

Interventions

Universal CD7-specific CAR gene-engineered T cellsBIOLOGICAL

Infusion of 4SCAR7U T cells

Universal 4SCAR7U cells to treat CD7-positive hematological malignancies

Eligibility Criteria

Age6 Months - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age older than 6 months.
  • Confirmed expression of CD7 and additional surface antigens in the cancer cells by immuno-histochemical staining or flow cytometry.
  • Karnofsky performance status (KPS) score is higher than 80 and life expectancy \> 3 months.
  • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5 × upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal, total bilirubin ≤ 2.0mg/dL.
  • Hgb≥80g/L.
  • No cell separation contraindications.
  • Abilities to understand and the willingness to provide written informed consent.

You may not qualify if:

  • Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection.
  • Active bacterial, fungal or viral infection not controlled by adequate treatment.
  • Known HIV or hepatitis C virus (HCV) infection.
  • Pregnant or nursing women may not participate.
  • Use of glucocorticoid for systemic therapy within one week prior to entering the trial.
  • Previous treatment with any gene therapy products.
  • Patients, in the opinion of investigators, may not be able to comply with the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, 518000, China

RECRUITING

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, Myeloid

Central Study Contacts

Lung-Ji Chang, Ph.D

CONTACT

86-136 7112 1909c@szgimi.org

Ying Deng

CONTACT

86-0755-8672 5195c@szgimi.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2023

First Posted

August 16, 2023

Study Start

October 31, 2023

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)