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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Refractory and Relapsed T Cell Lymphoma
• Intervention / Treatment: Biological: Humanized CD7 CAR-T cells

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jia Chen, M.D; Phone Number: +86 512 67781856; Email: chenjiasuzhou@gmail.com

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215000
      • Recruiting
      • The First Affiliated Hospital of Soochow University
      • Contact: Depei Wu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥ 18 years
2. R/R T-NHL with measurable (≧1.5cm) lesions confirmed by pathological immunohistochemistry or flow cytometry
3. The expressions of both CD4 and CD8 are negative in patients with bone marrow involved
4. The Eastern Cooperative Oncoloy Group (ECOG) physical condition score ≤ 2 points

5. 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%

6. Results of pregnant test should be negative, and agree to conception control during treatment and 1 year after CAR-T infusion
7. Expected survival exceeds 3 months
8. Written informed consent could be acquired

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CD7 positive relapsed or refractory T cell lymphoma; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete relapse rate(CR)	Number of patients who achieved complete response after treatment by CD7 CAR-T cell.	1 year
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
Progression-free survival(PFS)	PFS 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.	1 year

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Soochow University
• Collaborators: Affiliated Hospital of Jiangnan University; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; The First Affiliated Hospital of Dalian Medical University; The Affiliated Zhongshan Hospital of Dalian University; PersonGen BioTherapeutics (Suzhou) Co., Ltd.
• Investigators: Study Chair: Depei Wu, M.D&Ph.D, The First Affiliated Hospital of Soochow University

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2021
• Primary Completion (Anticipated): August 3, 2023
• Study Completion (Anticipated): August 3, 2024

Study Registration Dates

• First Submitted: September 17, 2021
• First Submitted That Met QC Criteria: September 17, 2021
• First Posted (Actual): September 28, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 17, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
• Other Study ID Numbers: CD7T

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No