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

Soochow University

Status and phase: Enrolling; Phase 2

Conditions: Refractory and Relapsed T Cell Lymphoma

Treatments: Biological: Humanized CD7 CAR-T cells

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05059912

CD7T

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

CD7 positive relapsed or refractory T cell lymphoma

Experimental group

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

Treatment:

Biological: Humanized CD7 CAR-T cells