Clinical trial NCT05059912: CD7 CAR T-cell for R/R CD7+ T Cell Lymphoma
Official title: Humanized CD7 CAR T-cell Therapy for R/R CD7+ T Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Refractory and Relapsed T Cell Lymphoma
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
Collaborators: name: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Affiliated Hospital of Jiangnan University
name: The Affiliated Zhongshan Hospital of Dalian University
name: The First Affiliated Hospital of Dalian Medical University
First posted: 2021-09-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: 1 year
measure: Number of Adverse Events
timeFrame: 1 year
Secondary outcomes:
measure: Complete relapse rate(CR)
timeFrame: 1 year
measure: Duration of overall response (DOR)
timeFrame: 1 year
measure: Progression-free survival(PFS)
timeFrame: 1 year
measure: Overall survival(OS)
timeFrame: 1 year
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Depei Wu, M.D&Ph.D
role: STUDY_CHAIR
References: