Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AUTO3 CD19/22 CAR T cells · 1 trial · 4 indications
DLT was defined as i) any new non-hematological adverse event (AE) of Grade 3 or higher toxicity using the NCI CTCAE (version 5.0), which was probably or definitely related to AUTO3 therapy, which occurred within the DLT evaluation period, and which failed to resolve to Grade 2 or better within 14 days, despite appropriate supportive measures; ii) Grade 4 cytokine release syndrome (CRS) or neurotoxicity, cerebral edema, or Grade 3 neurotoxicity (including cerebral edema) that lasted \>72 hours; iii) Grade \>3 disseminated intravascular coagulation; iv) Grade \>2 infusion reaction; v) Any other fatal event (Grade 5) or life-threatening event (Grade 4) that could not be managed with conventional supportive measures or which in the opinion of the Safety Evaluation Committee (SEC) necessitated dose reduction or other modification to trial treatment to avoid a similar hazard in future patients.
Morphological response evaluations were based on the response criteria for ALL according to the NCCN guidelines version 2.2014. Minimal residual disease-negative status was achieved if MRD was \<10\^-4 (0.01%) by PCR amplification of individual rearrangements of Ig genes and/or flow cytometry MRD testing.
| Arm | Type | Description |
|---|---|---|
| AUTO3 | EXPERIMENTAL | Paediatric patients with relapse or refractory B-cell ALL |
| Name | Type | Description |
|---|---|---|
| AUTO3 (CD19/22 CAR T cells | BIOLOGICAL | Following preconditioning with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with 1 to 5.0 x 10⁶/kg CD19/CD22 Chimeric Antigen Receptor (CAR) positive T cells as a single or split dose. |
Key Inclusion Criteria: 1. Male or female patients aged 1-24 years with high risk (HR) relapsed/refractory B-lineage ALL, AND: 1. Any bone marrow (BM) relapse or central nervous system (CNS) relapse with detectable BM disease after allogeneic stem cell transplant (SCT) and must be ≥6 months fro...
AUTO3 CD19/22 CAR T cells is an investigational cell therapy being developed for the treatment of B Acute Lymphoblastic Leukemia (ALL), including recurrent and refractory childhood ALL. It is a bispecific CAR T cell product designed to target two antigens, CD19 and CD22, on B cells. It is currently in Phase 1 clinical development.
AUTO3 CD19/22 CAR T cells targets both CD19 and CD22, two proteins found on B cells. By engineering a patient's T cells to recognize these targets, the therapy aims to direct the immune system to attack and eliminate cancerous B cells in B Acute Lymphoblastic Leukemia. This dual targeting is intended to improve treatment efficacy.
AUTO3 CD19/22 CAR T cells is being developed by Autolus Therapeutics plc, a biopharmaceutical company. The company's stock is traded under the ticker symbol AUTL. Autolus is focused on developing next-generation T cell therapies for the treatment of cancer, including this investigational CAR T cell product.
AUTO3 CD19/22 CAR T cells is in Phase 1 clinical development. It is an investigational therapy, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The Phase 1 trial has been completed, and the therapy is not yet available outside of clinical research settings.
AUTO3 CD19/22 CAR T cells has been studied in one clinical trial, identified as NCT03289455. This Phase 1 trial, titled "CD19/22 CAR T Cells (AUTO3) for the Treatment of B Cell Acute Lymphoblastic Leukemia (ALL)," was conducted in the United Kingdom and enrolled 23 participants. The trial has been completed.
Yes, AUTO3 CD19/22 CAR T cells is also known as CD19/22 CAR T cells. The product is designed to target both CD19 and CD22 antigens, and it is being evaluated for the treatment of B Acute Lymphoblastic Leukemia. This dual-targeting approach distinguishes it from single-target CAR T cell therapies.