Drugs / UCART22
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT04150497 | Oct 2019 → Jun 2026 overdue | B-cell acute lymphoblastic leukemia | Cellectis S.A. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 2026-06-11 | Cellectis S.A. | Results Cellectis Presents Final Phase 1 Results of Lasme-cel and Preliminary Results on Eti-cel at EHA 2026 Congress cellectis.com ↗
An overall response rate (ORR) of 100% (7/7) was achieved with a complete remission/complete remission with incomplete count recovery (CR/CRi) rate of 57% (4/7). |
| 2025-11-03 | Cellectis S.A. | Results Cellectis to Present a Development Update for eti-cel at ASH 2025 cellectis.com ↗
Correlation between alemtuzumab exposure and response with lasme-cel (UCART22) allows optimization of efficacy without an increase in toxicities |
| 2025-10-16 | Cellectis S.A. | Results Cellectis’ R&D Day Highlights Lasme-cel’s Potential to Address Significant Unmet Need for Patients with r/r B-ALL cellectis.com ↗
We are encouraged by the Phase 1 results of the BALLI-01 study in a population that had largely exhausted treatment options and faced a poor prognosis. |
| 2025-05-12 | Cellectis S.A. | Results Cellectis to Present Clinical Data on Lasme-cel and Eti-cel at EHA 2026 Annual Congress cellectis.com ↗
The depth of response we observed offers hope for these patients and demonstrates the potential for lasme-cel to become an effective therapeutic option for those with the highest unmet need. |
| 2024-07-25 | Cellectis S.A. | Regulatory FDA Grants Orphan Drug and Rare Pediatric Disease Designation Status to Cellectis’ UCART22 product candidate for Acute Lymphoblastic Leukemia (ALL) Treatment cellectis.com ↗
Cellectis (the “Company”) (Euronext Growth: ALCLS - NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug (ODD) and Rare Pediatric Disease Designation (RPDD) Status to UCART22 product candidate for the treatment of Acute Lymphoblastic Leukemia (ALL). |
| 2024-06-04 | Cellectis S.A. | Regulatory Cellectis Receives Orphan Drug Designation for UCART22, its Allogeneic CAR T Product for Patients with Acute Lymphoblastic Leukemia cellectis.com ↗
The Orphan Drug Designation for UCART22 marks an important step towards developing allogeneic CAR T products that would be readily available for all patients. |
| 2023-11-06 | Cellectis S.A. | Results Cellectis Reports Financial Results for Third Quarter and First Nine Months 2023 cellectis.com ↗
UCART22 P2 was administered after fludarabine, cyclophosphamide, and alemtuzumab (FCA) lymphodepletion and was well tolerated. |
| 2023-06-08 | Cellectis S.A. | Results Cellectis Presents Updated Clinical and Translational Data on BALLI-01 at the European Hematology Association (EHA) 2023 cellectis.com ↗
Cellectis (the “Company”) (Euronext Growth: ALCLS - NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, presented today updated clinical and translational data on its clinical trial BALLI-01 (evaluating UCART22) at the European Hematology Association (EHA) 2023. |
| 2023-05-11 | Cellectis S.A. | Results Cellectis Announces Poster Presentation on BALLI-01 at the European Hematology Association (EHA) 2023 cellectis.com ↗
The data show that UCART22 was well tolerated and clinical responses were achieved. |
| 2022-12-13 | Cellectis S.A. | Results Cellectis Announces Positive Preliminary Clinical Data for UCART22 in ALL and UCART123 in AML cellectis.com ↗ |
| 2021-12-11 | Cellectis S.A. | Results Cellectis Reports Encouraging Clinical Data from BALLI-01 Study in Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia, and Preclinical Data from TALGlobin01 at the 63rd American Society of Hematology Annual Meeting cellectis.com ↗
We are excited by the encouraging preliminary results obtained from patients administered UCART22 after fludarabine, cyclophosphamide and alemtuzumab (FCA) lymphodepletion in the BALLI-01 study. |
| 2020-12-05 | Cellectis S.A. | Results Cellectis Reports Preliminary Results from its Phase 1 BALLI-01 Study of UCART22 in R/R Adult B-ALL at American Society of Hematology (ASH) Annual Meeting cellectis.com ↗ |
| 2020-11-05 | Cellectis S.A. | Results Cellectis Provides Business Update and Reports Financial Results for Third Quarter and First Nine Months 2020 cellectis.com ↗
UCART22 demonstrated preliminary signs of activity at low dose levels with fludarabine/cyclophosphamide lymphodepletion regimen, with neither unexpected nor significant treatment-related toxicities. |
| 2020-11-04 | Cellectis S.A. | Results American Society of Hematology (ASH) Abstract Shows Initial Anti-Leukemic Activity of UCART22 in BALLI-01 Phase 1 Study in R/R Adult B-ALL cellectis.com ↗
2 out of 3 Patients at DL1 Achieved CR/CRi and 1 out of 2 Patients at DL2 Achieved a Significant Reduction in Bone Marrow Blasts |
| 2018-06-04 | Cellectis S.A. | Regulatory FDA Grants Cellectis IND Approval for UCART22 in B-ALL cellectis.com ↗
FDA) has approved the Company’s Investigational New Drug (IND) application to initiate a Phase 1 clinical trial for UCART22 |
| 2018-05-02 | Cellectis S.A. | Regulatory Cellectis Files IND for UCART22 in Acute Lymphoblastic Leukemia (B-ALL) cellectis.com ↗ |
All press releases naming this drug 19 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | UCART22 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04150497 ↗ |
| Modality | Cell therapy | “Allogeneic engineered T-cells expressing anti-CD22 Chimeric Antigen Receptor” NCT04150497 ↗ |
| Route | Intravenous | “UCART22 administered intravenously” NCT04150497 ↗ |
| Target | CD22 | “anti-CD22 Chimeric Antigen Receptor” NCT04150497 ↗ |