T-cell Acute Lymphoblastic Leukemia, T-cell Acute Lymphoblastic Lymphoma, T-cell Non-Hodgkin Lymphoma
Conditions
Keywords
Anti-CD7 CAR, CD7CAR, T cell leukoma/lymphoma, T-ALL, T-cell acute lymphoblastic leukemia, T-cell acute lymphoblastic lymphoma
Brief summary
This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of non-gene edited anti-CD7 CAR (also called anti-CD7 CAR) T cells in patients with relapsed and/or refractory T cell lymphoma or leukemia
Detailed description
Anti-CD7 CAR is a chimeric antigen receptor immunotherapy treatment designed to treat leukemia/lymphoma expressing CD7 antigen. T-cell acute lymphoblastic leukemia, T-acute lymphoblastic lymphoma and T-cell non-Hodgkin lymphoma are a subset of leukemias and lymphomas that are positive for the surface protein CD7. The purpose of this study is to evaluate the efficacy and safety of anti-CD7 CAR T cells.
Interventions
BIOLOGICALCD7 CAR T cells
Non-gene edited anti-CD7 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
Eligibility
Sex/Gender
ALL
Age
18 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 |
|---|---|---|
| Dose limiting toxicity (DLT) | The first 28 days after infusion | Number of participants with dose limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 |
| Type of dose-limiting toxicity (DLT) | The first 28 days after infusion | Type of dose-limiting toxicity (DLT) |
| Adverse event by severity | 2 years | Number of participants with adverse event by severity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate of ant-CD7 CAR | 1 year | Assessment of morphologic complete remission (CR), complete remission with incomplete recovery of counts (CR1), no residual disease as analyzed by flow cytometry analysis, and molecular remission by molecular studies |
| Progression-free survival (PFS) | 1 year | Progression-free survival (PFS) |
| Overall survival | 1 year | Overall survival |
Countries
China
Contacts
Primary ContactKevin Pinz, MS
Backup ContactYupo Ma, MD/PhD
Outcome results
None listed