Refractory T-Cell Lymphoma, T Cell Lymphoma in Relapse
Conditions
Keywords
CD4-specific CAR T, T cell leukemia, T cell lymphoma, CD4CAR
Brief summary
This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD4 CAR T cells in patients with relapsed and/or refractory T cell lymphoma.
Detailed description
CD4-specific CAR is a chimeric antigen receptor immunotherapy treatment designed to treat lymphoma/leukemia expressing CD4 antigen. CD4+ T cell lymphomas are a subset of leukemias and lymphomas that are positive for the surface protein CD4. The purpose of this study is to evaluate the efficacy and safety of CD4 CAR T cells.
Interventions
BIOLOGICALCD4 CAR T cells
CD4 CAR T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy.
Sponsors
iCAR Bio Therapeutics Ltd.
Peking University Shenzhen Hospital
iCell Gene Therapeutics
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Dose escalation phase: CD4 CAR T cells transduced with a lentiviral vector to express CD4 chimeric receptor domain on T cells with an escalation approach, 2e6 to 5e6 CAR-T cells/kg
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed written informed consent; Patients volunteer to participate in the research * Diagnosis is mainly based on the World Health Organization (WHO) 2008 * Patients have exhausted standard therapeutic options * Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 weeks * Female must be not pregnant during the study
Exclusion criteria
* Patients declining to consent for treatment * Prior solid organ transplantation * Potentially curative therapy including chemotherapy or hematopoietic cell transplant * Any drug used for GVHD must be stopped \>1 week
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events after CD4 CAR T cells cell infusion | 2 years particularly the first 28 days after infusion | Determine the toxicity profile of CD4 CAR T cell therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent adverse events | up to 6 months | Incidence of treatment-emergent adverse events |
| Disease Free Survival (DFS) | up to 2 years | Disease Free Survival (DFS) (IMWG criteria) |
| Progression-Free Survival (PFS) | up to 2 years | Progression-Free Survival (IMWG criteria) |
| Overall Survival (OS) | up to 2 years | overall survival |
Countries
China
Contacts
Primary ContactKevin Pinz, MS
Backup ContactYupo Ma, MD/PhD
Outcome results
None listed