NCT05059912

Brief Summary

This is a prospective, open-label, multiple center and single arm phase 2 study to evaluate the efficacy and safety of T cells expressing humanized CD7 chimeric antigen receptors treatment for patients with refractory/relapsed CD7 positive T cell lymphoma.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2021

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 5, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 17, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 28, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2024

Completed
Last Updated

September 28, 2021

Status Verified

August 1, 2021

Enrollment Period

2 years

First QC Date

September 17, 2021

Last Update Submit

September 17, 2021

Conditions

Refractory and Relapsed T Cell Lymphoma

Outcome Measures

Primary Outcomes (2)

  • Overall response rate (ORR)

    Number of patients who achieved response (complete response and partial response ) after treatment of CD7 CAR-T cell. Response will be assessed using the Lugano criteria.

    1 year

  • Number of Adverse Events

    Adverse events are evaluated with CTCAE V5.0

    1 year

Secondary Outcomes (4)

  • Complete relapse rate(CR)

    1 year

  • Duration of overall response (DOR)

    1 year

  • Progression-free survival(PFS)

    1 year

  • Overall survival(OS)

    1 year

Study Arms (1)

CD7 positive relapsed or refractory T cell lymphoma

EXPERIMENTAL

Humanized CD7 CAR-T cells intravenously infused to patient with R/R T-NHL\[ at a dose of (0.5- 5)x10\^6 CD7 CAR-T cells/kg

Biological: Humanized CD7 CAR-T cells

Interventions

Humanized CD7 CAR-T cellsBIOLOGICAL

Patients will receive infusion of CAR T-cells targeting CD7 to confirm the safety and efficacy of CD7 CAR T-Cells in CD7+ relapsed or refractory T cell lymphoma

CD7 positive relapsed or refractory T cell lymphoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • R/R T-NHL with measurable (≧1.5cm) lesions confirmed by pathological immunohistochemistry or flow cytometry
  • The expressions of both CD4 and CD8 are negative in patients with bone marrow involved
  • The Eastern Cooperative Oncoloy Group (ECOG) physical condition score ≤ 2 points
  • The main organ functions need to meet the following conditions:
  • A.Left ventricular ejection fraction ≥50% B.Creatinine ≤132umol/l or creatinine clearance ≥60 ml/min C.ALT and AST≤2.5 upper limitation of normal D.T-BIL≤2.0mg/dl E.SpO2 \> 90%
  • Results of pregnant test should be negative, and agree to conception control during treatment and 1 year after CAR-T infusion
  • Expected survival exceeds 3 months
  • Written informed consent could be acquired

You may not qualify if:

  • Immunosuppressant medications or steroids were used within 2 weeks before cell collection, or need to use steroids or immunosuppressant medications more than two years
  • Patients with uncontrolled active infection
  • Active hepatitis B or hepatitis C infection
  • Patients with HIV infection
  • Severe acute or chronic graft-versus-host disease (GVHD)
  • Participated in any other drug research clinical trials within 30 days before enrollment
  • Prior CAR-T cells therapy within 3 months before enrollment
  • Prior allogeneic hematopoietic stem cell transplantation within 6 months before enrollment
  • Uncontrolled other tumor
  • Women in pregnancy, lactation or planning to become pregnant
  • The researcher considers inappropriate to participate in this research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Depei Wu, M.D&Ph.D

    The First Affiliated Hospital of Soochow University

    STUDY CHAIR

Central Study Contacts

Caixia Li, M.D

CONTACT

+86 512 67781856licaixia@suda.edu.cn

Jia Chen, M.D

CONTACT

+86 512 67781856chenjiasuzhou@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2021

First Posted

September 28, 2021

Study Start

August 5, 2021

Primary Completion

August 3, 2023

Study Completion

August 3, 2024

Last Updated

September 28, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)