T-cell Lymphoma (PTCL and CTCL), T-Cell Non-Hodgkin Lymphoma
Conditions
Brief summary
This is a multi-center, open-label, non-randomized, single-arm clinical trial. Refractory/relapse T-NHL patients are treated with autologous and allogeneic CD7 CAR T-cell therapy. The primary objective is to prospectively evaluate the safety of CD7 CAR T cell bridging to HSCT in the treatment of r/r T-NHL. The primary endpoint is the type and incidence of dose limiting toxicity (DLT) within 21 days after CD7 CAR-T cell infusion. A total of 36 subjects is estimated to be enrolled.
Interventions
Approximately 3-5 days prior to CD7 CAR-T cell infusion, subjects are treated with FC regimen (fludarabine and cyclophosphamide) for lymphodepletion. CAR-T cell infusion are performed 48 h after completion of chemotherapy.
Sponsors
Ruijin Hospital
Shanghai Liquan Hospital
Beijing GoBroad Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
(Patients who met all the inclusion criteria were eligible for enrolment): * Relapsed or refractory CD7-positive T-cell lymphomas that were treated with with standard chemotherapy, with poor prognosis from currently available treatments at and no available treatment options (e.g., HSCT or chemotherapy); * Male or female, age 14-70; * Eastern Cooperative Oncology Group (ECOG) Physical Status Score 0-2; * life expectancy is at least 60 days; * Subjects should be capable of understanding and signing the informed consent form prior to any screening procedures. Subjects are willing to follow the study visit schedule and associated study procedures as specified in the protocol. Candidates between the ages of 19-70 years old will need to be sufficiently aware of and capable of signing the informed consent form; underage candidates between the ages of 14-18 years old will need to be sufficiently aware of the informed consent form and their legal guardian will also need to sign the informed consent form separately.
Exclusion criteria
(Patients who fulfil any of the following criteria may not be enrolled): * Patients with history of allogeneic HSCT but PBMNC is not available from prior- transplant donor for preparation of CAR T cells and peripheral blood tumour load \>30%; patients without history of allogeneic HSCT and peripheral blood tumour load \>30%; * Intracranial hypertension or cerebral impaired consciousness; * Symptomatic heart failure or severe arrhythmia; * Symptoms of severe respiratory failure; * With other types of malignancy; * Diffuse intravascular coagulation; * Serum creatinine and/or urea nitrogen ≥ 1.5 times the normal value; * With sepsis or other uncontrollable infection; * Suffering from uncontrollable diabetes mellitus; * Severe mental disorders; * Have significant intracranial lesions on cranial MRI; * Organ transplantation (excluding haematopoietic stem cell transplantation) history; * Female patients (patients of childbearing potential) with positive blood HCG test; * Hepatitis (including hepatitis B and C) and positive screening for AIDS and syphilis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-limiting toxicity (DLT) | 21 days | Incidence and type of dose-limiting toxicity(DLT) within 21 days of CD7 CAR-T infusion. |
| Adverse events (AEs) | 21 days | Total number, incidence and severity of adverse events (AEs) within 21 days of CD7 CAR-T infusion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | 21, 90 days | The assessment of ORR by dose group at 21 and 90 Days after CD7 CAR T infusion. |
| Duration of response (DOR) | up to 2 years | DOR is defined as the date when CR response criteria are first met to the date of relapse or death caused by T-NHL in the absence of documented relapse |
Countries
China
Contacts
Primary ContactHaiyang LU, Ph.D
Outcome results
None listed