Trial Title:
Clinical Study of CD7 CAR-T Cell Injection in the Treatment of Patients With Relapsed or Refractory CD7-positive Peripheral T Cell Lymphoma
NCT ID:
NCT05979792
Condition:
Peripheral T Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
CAR-T Therapy
Description:
CAR-T cell infusion
Arm group label:
CAR-T Therapy
Summary:
Despite the use of monoclonal antibodies, checkpoint inhibitors, and bispecific T cell
adapters (BiTE) Immunotherapies such as chimeric antigen receptor (CAR) T cells have
completely changed the treatment methods of various cancers.
However, only limited responses were observed in T cell diseases, In CD30 positive PTCL
and CTCL patients. The use of BV in and pembroluzimab (Programmed cell death receptor 1)
in the treatment of ENKTL.
Although some promising results have been observed for (PD-1) inhibitors, these positive
results are limited to specific subtypes of T cell diseases.
CAR T Cell therapy in recurrent/refractory B-cell malignant tumors is very successful,
the Food and Drug Administration (FDA) has approved two CAR T Cell therapy for the
treatment of this type of disease. However, using this technology to treat T-cell
malignancies has always been difficult, mainly due to the lack of tumor specific surface
antigens in cancerous T cells.
Therefore, our center plans to conduct a phase I clinical study of CAR-T to explore the
possibility of bringing more treatment options and benefits to PTCL patients.
Detailed description:
Patients with recurrent/refractory PTCL were included using a single arm, open label, and
single center approach.
Pre treatment plan:
Cyclophosphamide (CTX): 500mg/m2 × 3 days
Fludarabine: 30mg/m2 × 3 days
Note: Researchers can adjust the pre-treatment plan appropriately based on the patient's
condition, such as CTX 300mg × Wait for 3 days.
CTX and Flu were infused on the 5th to 3rd day (D-5 to D-3) before administration.
RD13-02 can only be injected after 48 hours of pre-treatment.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥ 18 years old and<80 years old.
2. According to the clinical practice guidelines for T-cell lymphoma of the National
Comprehensive Cancer Network (NCCN) (2022. v2), diagnosis of peripheral T-cell
lymphoma, including but not limited to: peripheral T Cell lymphoma, non-specific
type (PTCL-NOS), anaplastic large cell lymphoma (ALCL), T helper cell lymphoma
(FTCL), peripheral lymph nodes with follicular helper T cell phenotype T-cell
lymphoma (TFH) and angioimmunoblastic T-cell lymphoma (AITL), Etc;
3. Relapse or refractory peripheral T-cell lymphoma, which requires at least 2
systematic Sex therapy, is invalid or relapses.
4. Histologically confirmed as CD7 positive.
5. According to Lugano2014 standard, enhanced CT before enrollment should indicate at
least one evaluable tumor lesion (with the longest diameter of the intranodal
lesion>1.5cm and the longest diameter of the extranodal lesion>1.0cm), and PET/CT
should show metabolic activity.
6. Blood routine neutrophil count ≥ 1.0 during screening × 109/L; For individuals
without bone marrow invasion, platelet count ≥ 75 × 109/L, Hb ≥ 80g/L; For
individuals with bone marrow invasion, platelet count ≥ 50 × 109/L, Hb ≥ 60g/L (if
the patient does not meet the screening requirements but meets the screening period
requirements for re examination, they can be selected).
7. The average fluorescence intensity (MFI) of donor specific antibodies (DSA) at HLA
sites of HLA antibody negative or anti RD13-02 cell derived donors is less than
2000.
8. Creatinine clearance rate>60ml/min (Cockcroft and Gault formula); For patients
without liver invasion, serum total bilirubin ≤ 1.5 times the upper limit of normal
value, and serum ALT and AST ≤ 3 times the upper limit of normal value range; For
patients with liver invasion, serum total bilirubin ≤ 3 times the upper limit of
normal value, and serum ALT and AST ≤ 5 times the upper limit of normal value range.
9. Echocardiography showed that left ventricular Ejection fraction (LVEF) ≥ 50%.
10. Estimated survival time of over 3 months.
11. ECOG: 0-1.
12. Subjects or their Legal guardian voluntarily participate in the trial and sign the
informed consent form.
13. For patients undergoing reinfusion, in addition to meeting the relevant conditions
for reinfusion in the Design of experiments, it is required that there is no DLT
event or dose reduction after the first infusion.
14. The first 6 subjects included at any dose level should be able to collect sufficient
amounts of autologous hematopoietic stem cells for cryopreservation in advance;
Subsequent subjects will be determined by the researcher whether to collect
autologous hematopoietic stem cells for cryopreservation.
Exclusion Criteria:
1. Primary cutaneous T-cell lymphoma, including mycosis fungoides (MF) and Sezary
syndrome (SS); Enteropathy associated T-cell lymphoma (EATL), monotypic
epitheliophagocytic intestinal T-cell lymphoma (MEITL), hepatosplenic T-cell
lymphoma (HSTCL), extranodal NK/T-cell lymphoma, nasal type (EENKTCL) and primary
central nervous system lymphoma and other types of T-cell leukemia/lymphoma.
2. Active central nervous system (CNS) invasion.
3. If anti-tumor treatment has been received before infusion, it should be excluded if
any of the following conditions are met:
- received small molecule Targeted therapy within 72 hours
- Received systemic chemotherapy within 2 weeks (excluding pre-treatment)
- Received radiation therapy within 4 weeks
- When the time between the last monoclonal antibody infusion and those who have
received monoclonal antibody treatment is less than 5 half-lives four weeks
long or less (whichever is shorter)
4. Individuals with a history of allergies to any component in cellular products.
5. According to the New York Heart Association (NYHA) cardiac function grading
standards, subjects with cardiac dysfunction classified as Class III or IV.
6. Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or
other serious heart disease clinically within 12 months of enrollment.
7. The electrocardiogram indicates that the QT interval is significantly prolonged, and
the patient has serious heart disease such as serious arrhythmia in the past.
8. Previous history of craniocerebral trauma, Disorders of consciousness, epilepsy,
cerebrovascular ischemia, cerebrovascular hemorrhagic disease, etc.
9. Uncontrolled severe active infections (excluding simple urinary tract infections and
bacterial pharyngitis).
10. The subject has a history of other primary cancers, except for the following:
1. Non Melanoma cured by excision, such as skin Basal-cell carcinoma;
2. Carcinoma in situ of cervix, local prostate cancer, and ductal Carcinoma in
situ with disease-free survival ≥ 2 years after adequate treatment;
11. Subjects with autoimmune diseases requiring treatment or subjects requiring
Immunosuppressive drug treatment;
12. Individuals with graft versus host disease (GvHD) and/or requiring immunosuppressive
therapy.
13. Live vaccination within 4 weeks prior to screening.
14. The subject has a history of alcoholism, drug abuse, or mental illness.
15. Individuals with EBV DNA copy numbers greater than the upper limit of normal or
positive for EBER; CMV copies greater than the upper limit of normal values; HBV or
HCV DNA copy number>the upper limit of normal value, and active syphilis or AIDS and
other virus infected persons.
16. Subjects who were receiving systemic Sex hormone treatment before screening and who
were judged by the investigator to need long-term use of systemic Sex hormone during
treatment (except for inhalation or local use).
17. Individuals who have participated in other clinical trials within the first 4 weeks
of screening.
18. Pregnant and lactating women and subjects with Fertility who cannot take effective
contraceptive measures (both men and women).
19. Any situation that the researcher believes may increase the risk of the subject or
interfere with the test results.
Gender:
All
Minimum age:
18 Years
Maximum age:
79 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of USTC
Address:
City:
Hefei
Zip:
230000
Country:
China
Contact:
Last name:
Xiaoyu Zhu, Doctor
Investigator:
Last name:
Xiaoyu Zhu, Doctor
Email:
Principal Investigator
Facility:
Name:
The First Affliliated Hospital of Xiamen University
Address:
City:
Xiamen
Zip:
361000
Country:
China
Contact:
Last name:
Bing Xu, Doctor
Investigator:
Last name:
Bing Xu, Doctor
Email:
Principal Investigator
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450000
Country:
China
Contact:
Last name:
Keshu Zhou, Doctor
Investigator:
Last name:
Keshu Zhou, Doctor
Email:
Principal Investigator
Facility:
Name:
The First Affliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Zip:
450000
Country:
China
Contact:
Last name:
Mingzhi Zhang, Doctor
Investigator:
Last name:
Mingzhi Zhang
Email:
Principal Investigator
Facility:
Name:
The Affliliated Hospital of Northwest University
Address:
City:
Xi'an
Zip:
710000
Country:
China
Contact:
Last name:
Xiequn Chen, Doctor
Investigator:
Last name:
Xiequn Chen, Doctor
Email:
Principal Investigator
Facility:
Name:
West China Hospital Sichuan University
Address:
City:
Chengdu
Zip:
610000
Country:
China
Contact:
Last name:
Tin Niu, Doctor
Investigator:
Last name:
Tin Niu, Doctor
Email:
Principal Investigator
Facility:
Name:
The 920th Hospital of the Joint Service Support Force of the People's Liberation Army
Address:
City:
Kunming
Zip:
650000
Country:
China
Contact:
Last name:
Sanbin Wang, Doctor
Investigator:
Last name:
Sanbin Wang, Doctor
Email:
Principal Investigator
Facility:
Name:
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Address:
City:
Shanghai
Country:
China
Contact:
Last name:
Weili Zhao, Doctor
Start date:
September 1, 2023
Completion date:
December 1, 2025
Lead sponsor:
Agency:
Zhao Weili
Agency class:
Other
Source:
Ruijin Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05979792
