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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-05

Study Completion Date

2024-08-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Refractory and Relapsed T Cell Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Humanized CD7 CAR-T cells

Intervention Type BIOLOGICAL

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

Interventions

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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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No