Acute Lymphoblastic Leukemia
Conditions
Keywords
CAR T-Cell Therapy, Acute lymphoblastic leukemia, CD19, non-viral, fast CAR
Brief summary
This is a Phase 1 study to evaluate FIT-CD19-CAR-T (ARM011) safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarkers.
Detailed description
This is an open-label, single arm, Phase 1 study to evaluate the safety and tolerability of FIT-CD19-CAR-T (ARM011) administered intravenously (IV) following a standard lymphodepleting (LD) chemotherapy regimen of cyclophosphamide and fludarabine in subjects with relapsed/refractory acute lymphoblastic leukemia (ALL). This dose finding study will use a 3+3 design.
Interventions
BIOLOGICALARM011
ARM011 is an autologous, CD19 targeted CAR T-cell product developed on fast-in-time (FIT) platform-a non-viral, 2-day rapid manufacturing process
DRUGFludarabine
Administered prior to infusion of ARM011
DRUGCyclophosphamide
Administered prior to infusion of ARM011
Sponsors
TriArm Therapeutics (Taiwan) Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Male or female subjects age ≥18 years 2. Diagnosis of ALL 3. Refractory to or relapsed after current standard treatment, and not suitable or unable to wait for other treatment options 4. Disease burden: Bone marrow with evidence of disease. 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. 6. Adequate organ functions 7. Life expectancy ≥12 weeks Key
Exclusion criteria
1. Active central nervous system (CNS) involvement of ALL 2. Burkitt's lymphoma or chronic myeloid leukemia (CML) lymphoid blast crisis 3. Prior anti-CD19 therapy (other than blinatumomab) 4. Subjects who have experienced Grade 3 or higher cytokine release syndrome (CRS)/neurotoxicity following blinatumomab. 5. autoimmune disease resulting in end-organ injury or requiring systemic immunosuppression within the last 2 years. 6. History or presence of cardiac or CNS disorders as defined in the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events [Safety and Tolerability] | Up to 24 months after ARM011 infusion | Safety and Tolerability: Proportion of subjects experiencing adverse events and dose-limiting toxicities |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate cellular kinetics and persistence of ARM011 | Up to 24 months after ARM011 infusion | Cellular kinetics related peak (Cmax) in peripheral blood |
| Evaluate preliminary anti-tumor activity of ARM011 | Up to 24 months after ARM011 infusion | Preliminary anti-tumor activity: Proportion of subjects with an objective response (including complete response or complete remission with incomplete count recovery) |
| Evaluate host immunogenicity to ARM011 | Up to 24 months after ARM011 infusion | Incidence of anti-CD19-directed CAR antibodies |
| Evaluate the feasibility of administration of ARM011 | 24 months | The proportion of subjects for whom a CAR T-cell product meeting specifications could be prepared, which will be computed with a corresponding 95% confidence interval (CI). |
Countries
Taiwan
Contacts
Primary ContactReta Ruan
Backup ContactYiming Gong, MD
Outcome results
None listed