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

Phase 2

• Conditions: Refractory and Relapsed T Cell Lymphoma

• Registration Number: NCT05059912
• Lead Sponsor: The First Affiliated Hospital of Soochow University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-08
• Study Start: 2021-08-05
• Study First Submitted: 2021-09-17
• Study First Submitted QC: 2021-09-17
• Last Update Submitted: 2021-09-17
• Study First Posted: 2021-09-28
• Last Update Posted: 2021-09-28
• Primary Completion: 2023-08-03
• Study Completion: 2024-08-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Overall response rate (ORR)	1 year	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	1 year	Adverse events are evaluated with CTCAE V5.0

Secondary Outcome Measures

Name	Time	Method
Progression-free survival(PFS)	1 year	PFS will be assessed from the CAR-T cell infusion to progression, death or last follow-up.
Overall survival(OS)	1 year	OS will be assessed from the CAR-T cell infusion to death or last follow-up.
Complete relapse rate(CR)	1 year	Number of patients who achieved complete response after treatment by CD7 CAR-T cell.
Duration of overall response (DOR)	1 year	Duration of overall response will be assessed from the CAR-T cell infusion to progression, death or last follow-up.

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China