T-cell Acute Lymphoblastic Leukemia, T-cell Non-Hodgkin Lymphoma
Conditions
Keywords
anti-CD5 CAR, T cell leukemia/lymphoma, T-ALL
Brief summary
This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of anti-CD5 CART cells in patients with relapsed and/or refractory T cell lymphoma or leukemia.
Detailed description
Anti- CAR is a chimeric antigen receptor immunotherapy treatment designed to treat lymphoma/leukemia expressing CD5 antigen. CD5+ T cell lymphomas or leukemia are a subset of leukemias and lymphomas that are positive for the surface protein CD5. The purpose of this study is to evaluate the efficacy and safety of anti-CD5 CAR T cells.
Interventions
DRUGanti-CD5 CAR T cells
anti-CD5 CAR T cells transduced with a lentiviral vector to express CD5 chimeric receptor domain on T cells
Sponsors
iCAR Bio Therapeutics Ltd.
Peking University Shenzhen Hospital
iCell Gene Therapeutics
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed written informed consent; Patients volunteer to participate in the research 2. Diagnosis is mainly based on the World Health Organization (WHO) 2008 3. Patients have exhausted standard therapeutic options 4. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 weeks 5. Female must be not pregnant during the study
Exclusion criteria
1. Patients declining to consent for treatment 2. Prior solid organ transplantation 3. Potentially curative therapy including chemotherapy or hematopoietic cell transplant 4. Any drug used for GVHD must be stopped \>1 week
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events after anti-CD5 CAR T cells cell infusion | 2 years particularly the first 28 days after infusion | Determine the toxicity profile of anti-CD5 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) |
| Progression-Free Survival (PFS) | up to 2 years | Progression-Free Survival (PFS) |
| Overall Survival (OS) | up to 2 years | Overall Survival (OS) |
Countries
China
Contacts
Primary ContactKevin G Pinz, MS
Outcome results
None listed