Refractory and Relapsed T Cell Lymphoma
Conditions
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.
Interventions
BIOLOGICALHumanized 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
Sponsors
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Affiliated Hospital of Jiangnan University
Affiliated Zhongshan Hospital of Dalian University
The First Affiliated Hospital of Dalian Medical University
The First Affiliated Hospital of Soochow University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
China
Contacts
Primary ContactCaixia Li, M.D
Backup ContactJia Chen, M.D
Outcome results
None listed