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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 developed for the treatment of relapsed or refractory CD22-positive B-cell acute lymphoblastic leukemia (B-ALL). It is designed for patients whose disease has returned or has not responded to prior therapy. It has not been approved by the FDA and remains in clinical development.
UCART22 targets CD22, an antigen expressed on the surface of B-cell acute lymphoblastic leukemia cells. By directing therapeutic activity toward CD22, UCART22 aims to recognize and act on CD22-positive leukemic cells. CD22 is a validated B-cell antigen and the target used to select patients for this therapy.
UCART22 is being developed by Cellectis S.A., a clinical-stage biopharmaceutical company. Cellectis trades on the Nasdaq under the ticker symbol CLLS. The company is the sponsor of the ongoing clinical program evaluating UCART22 in B-cell acute lymphoblastic leukemia.
UCART22 is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA for any indication. The Phase 1/2 BALLI-01 study is currently recruiting participants and has an estimated enrollment of 52 patients.
UCART22 is being evaluated in the Phase 1/2 BALLI-01 study, registered as NCT04150497. The trial is titled a Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia. It is recruiting in the United States and France, with an estimated enrollment of 52 participants.
UCART22 has received Orphan Drug designation from the FDA for its development in B-cell acute lymphoblastic leukemia. Orphan Drug designation is granted to therapies intended for rare diseases. UCART22 remains investigational and has not received FDA approval for any indication.