CD7 CAR T-Cell Therapy for r/r T-cell Lymphomas

A Multicenter, Open-Label, Non-Randomized, Single-Arm Phase I/II Clinical Study of Autologous and New Donor CD7 CAR-T Cells for Relapsed or Refractory Mature T-Cell Lymphomas

This is a multi-center, open-label, non-randomized, single-arm clinical trial. Refractory/relapse T-NHL patients are treated with autologous and allogeneic CD7 CAR T-cell therapy. The primary objective is to prospectively evaluate the safety of CD7 CAR T cell bridging to HSCT in the treatment of r/r T-NHL. The primary endpoint is the type and incidence of dose limiting toxicity (DLT) within 21 days after CD7 CAR-T cell infusion. A total of 36 subjects is estimated to be enrolled.

Study Overview

• Status: Recruiting
• Conditions: T-Cell Non-Hodgkin Lymphoma; T-cell Lymphoma (PTCL and CTCL)
• Intervention / Treatment: Drug: CD7 CAR-T cells infusion

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Haiyang LU, Ph.D; Phone Number: 86+ 18221015770; Email: lhy13062@rjh.com.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 102200
      • Recruiting
      • Beijing GoBroad Hospital
      • Contact: Tengyu Wang, Ph.D; Phone Number: 86+18831006667; Email: miaosc@gobroadhealthcare.com
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
      • Contact: Haiyang LU, Ph.D; Phone Number: 86+18221015770; Email: lhy13062@rjh.com
    • Shanghai, Shanghai, China, 200435
      • Recruiting
      • Shanghai Liquan Hospital
      • Contact: Su LI, Ph.D; Phone Number: 86+4000215005
  • 广东
    • 湛江市, 广东, China, 524000
      • Recruiting
      • 湛江中心人民医院
      • Contact: 文瑞婷; Phone Number: 0759-2369336

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria (Patients who met all the inclusion criteria were eligible for enrolment):

• Relapsed or refractory CD7-positive T-cell lymphomas that were treated with with standard chemotherapy, with poor prognosis from currently available treatments at and no available treatment options (e.g., HSCT or chemotherapy);
• Male or female, age 14-70;
• Eastern Cooperative Oncology Group (ECOG) Physical Status Score 0-2;
• life expectancy is at least 60 days;
• Subjects should be capable of understanding and signing the informed consent form prior to any screening procedures. Subjects are willing to follow the study visit schedule and associated study procedures as specified in the protocol. Candidates between the ages of 19-70 years old will need to be sufficiently aware of and capable of signing the informed consent form; underage candidates between the ages of 14-18 years old will need to be sufficiently aware of the informed consent form and their legal guardian will also need to sign the informed consent form separately.

Exclusion Criteria (Patients who fulfil any of the following criteria may not be enrolled):

• Patients with history of allogeneic HSCT but PBMNC is not available from prior- transplant donor for preparation of CAR T cells and peripheral blood tumour load >30%; patients without history of allogeneic HSCT and peripheral blood tumour load >30%;
• Intracranial hypertension or cerebral impaired consciousness;
• Symptomatic heart failure or severe arrhythmia;
• Symptoms of severe respiratory failure;
• With other types of malignancy;
• Diffuse intravascular coagulation;
• Serum creatinine and/or urea nitrogen ≥ 1.5 times the normal value;
• With sepsis or other uncontrollable infection;
• Suffering from uncontrollable diabetes mellitus;
• Severe mental disorders;
• Have significant intracranial lesions on cranial MRI;
• Organ transplantation (excluding haematopoietic stem cell transplantation) history;
• Female patients (patients of childbearing potential) with positive blood HCG test;
• Hepatitis (including hepatitis B and C) and positive screening for AIDS and syphilis.

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 CAR-T therapy; Enrolled patients were treated with anti-CD7 CAR-T cells, with or without allo-HSCT bridging.	Drug: CD7 CAR-T cells infusion; Approximately 3-5 days prior to CD7 CAR-T cell infusion, subjects are treated with FC regimen (fludarabine and cyclophosphamide) for lymphodepletion. CAR-T cell infusion are performed 48 h after completion of chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose-limiting toxicity (DLT)	Incidence and type of dose-limiting toxicity(DLT) within 21 days of CD7 CAR-T infusion.	21 days
Adverse events (AEs)	Total number, incidence and severity of adverse events (AEs) within 21 days of CD7 CAR-T infusion.	21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	The assessment of ORR by dose group at 21 and 90 Days after CD7 CAR T infusion.	21, 90 days
Duration of response (DOR)	DOR is defined as the date when CR response criteria are first met to the date of relapse or death caused by T-NHL in the absence of documented relapse	up to 2 years

Collaborators and Investigators

• Sponsor: Beijing GoBroad Hospital
• Collaborators: Shanghai Ruijin Hospital, Shanghai Jiaotong University School of Medicine; Shanghai Liquan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: April 6, 2025
• First Submitted That Met QC Criteria: April 6, 2025
• First Posted (Actual): April 13, 2025

Study Record Updates

• Last Update Posted (Actual): May 13, 2025
• Last Update Submitted That Met QC Criteria: May 11, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
• Other Study ID Numbers: BJGBYY-IIT-LCYJ-2025-022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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