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CD7 CAR T-cell for R/R CD7+ T Cell Lymphoma

Primary Purpose

Refractory and Relapsed T Cell Lymphoma

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Humanized CD7 CAR-T cells

About this trial

This is an interventional treatment trial for Refractory and Relapsed T Cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

The First Affiliated Hospital of Soochow UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CD7 positive relapsed or refractory T cell lymphoma

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Number of Adverse Events

Adverse events are evaluated with CTCAE V5.0

Secondary Outcome Measures

Complete relapse rate(CR)

Number of patients who achieved complete response after treatment by CD7 CAR-T cell.

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.

Progression-free survival(PFS)

PFS will be assessed from the CAR-T cell infusion to progression, death or last follow-up.

Overall survival(OS)

OS will be assessed from the CAR-T cell infusion to death or last follow-up.

Full Information

NCT ID

NCT05059912

First Posted

September 17, 2021

Last Updated

September 17, 2021

Sponsor

The First Affiliated Hospital of Soochow University

Collaborators

PersonGen BioTherapeutics (Suzhou) Co., Ltd., The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Affiliated Hospital of Jiangnan University, The Affiliated Zhongshan Hospital of Dalian University, The First Affiliated Hospital of Dalian Medical University

1. Study Identification

Unique Protocol Identification Number

NCT05059912

Brief Title

CD7 CAR T-cell for R/R CD7+ T Cell Lymphoma

Official Title

Humanized CD7 CAR T-cell Therapy for R/R CD7+ T Cell Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Recruiting

Study Start Date

August 5, 2021 (Actual)

Primary Completion Date

August 3, 2023 (Anticipated)

Study Completion Date

August 3, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The First Affiliated Hospital of Soochow University

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Refractory and Relapsed T Cell Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CD7 positive relapsed or refractory T cell lymphoma

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Humanized CD7 CAR-T cells

Intervention Description

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

Primary Outcome Measure Information:

Title

Overall response rate (ORR)

Description

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.

Time Frame

1 year

Title

Number of Adverse Events

Description

Adverse events are evaluated with CTCAE V5.0

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Complete relapse rate(CR)

Description

Number of patients who achieved complete response after treatment by CD7 CAR-T cell.

Time Frame

1 year

Title

Duration of overall response (DOR)

Description

Duration of overall response will be assessed from the CAR-T cell infusion to progression, death or last follow-up.

Time Frame

1 year

Title

Progression-free survival(PFS)

Description

PFS will be assessed from the CAR-T cell infusion to progression, death or last follow-up.

Time Frame

1 year

Title

Overall survival(OS)

Description

OS will be assessed from the CAR-T cell infusion to death or last follow-up.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Caixia Li, M.D

Phone

+86 512 67781856

licaixia@suda.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Jia Chen, M.D

Phone

+86 512 67781856

chenjiasuzhou@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Depei Wu, M.D&Ph.D

Organizational Affiliation

The First Affiliated Hospital of Soochow University

Official's Role

Study Chair

Facility Information:

Facility Name

The First Affiliated Hospital of Soochow University

City

Suzhou

State/Province

Jiangsu

ZIP/Postal Code

215000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Depei Wu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

CD7 CAR T-cell for R/R CD7+ T Cell Lymphoma

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