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UCART22 · 1 trial · 1 indication
Incidence, nature, and severity of adverse events and serious adverse events (SAEs) throughout the study in relation to UCART22 and/or lymphodepletion
| Arm | Type | Description |
|---|---|---|
| Dose Escalation | EXPERIMENTAL | Several tested doses of UCART22 until the Maximum Tolerated Dose (MTD) is identified and establish Recommended Phase 2 Dose (RP2D) Dose Expansion: UCART22 administered at the RP2D |
| Name | Type | Description |
|---|---|---|
| UCART22 | BIOLOGICAL | Allogeneic engineered T-cells expressing anti-CD22 Chimeric Antigen Receptor given following a lymphodepleting regimen |
| CLLS52 | BIOLOGICAL | A monoclonal antibody that recognizes a CD52 antigen |
Inclusion Criteria: * B-ALL blast cells expressing CD22 * Diagnosed with R/R B-ALL * Prior therapy must include at least one standard chemotherapy regimen and at least one salvage regimen Exclusion Criteria: -Prior cellular therapy or investigational cellular or gene therapy within 90 days prior ...
UCART22 is an investigational cell therapy being studied for the treatment of B-cell Acute Lymphoblastic Leukemia (B-ALL). It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being evaluated in patients with relapsed or refractory CD22+ B-cell Acute Lymphoblastic Leukemia.
UCART22 targets CD22, an antigen expressed on B cells. By binding to CD22, the therapy is designed to recognize and eliminate cancerous B cells in patients with B-cell Acute Lymphoblastic Leukemia. This targeted approach is being studied in a Phase 1 clinical trial.
UCART22 is being developed by Cellectis S.A., a biopharmaceutical company listed on the stock exchange under the ticker CLLS. The company is conducting clinical trials to evaluate the safety and efficacy of UCART22 in patients with B-cell Acute Lymphoblastic Leukemia.
UCART22 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting patients to assess the treatment's safety and preliminary efficacy in B-cell Acute Lymphoblastic Leukemia.
UCART22 is being studied in a Phase 1/2 clinical trial with the identifier NCT04150497, known as the BALLI-01 study. This trial is recruiting patients with relapsed or refractory CD22+ B-cell Acute Lymphoblastic Leukemia and is being conducted in the United States and France.
UCART22 is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials. The FDA has granted UCART22 orphan drug designation for the treatment of B-cell Acute Lymphoblastic Leukemia, which provides certain development incentives, but approval has not been granted.