This section highlights FDA-related milestones and regulatory updates for drugs developed by Cellectis (CLLS).
Over the past two years, Cellectis has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Lasme-cel, UCART22, and TALEN®. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Lasme-cel FDA Regulatory Events
Lasme-cel is a drug developed by Cellectis for the following indication: in heavily pretreated patients with relapsed or refractory CD22+ B-cell acute lymphoblastic leukemia (r/r B-ALL).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Lasme-cel
- Announced Date:
- May 12, 2026
- Indication:
- in heavily pretreated patients with relapsed or refractory CD22+ B-cell acute lymphoblastic leukemia (r/r B-ALL)
Announcement
Cellectis announced upcoming presentations on the BALLI-01 and NATHALI-01 clinical trials, at the European Hematology Association (EHA) annual congress, on June 11-14, 2026, in Stockholm, Sweden.
Read Announcement
UCART22 FDA Regulatory Events
UCART22 is a drug developed by Cellectis for the following indication: For patients with relapsed or refractory CD22+ B-cell acute lymphoblastic leukemia.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- UCART22
- Announced Date:
- October 16, 2025
- Indication:
- For patients with relapsed or refractory CD22+ B-cell acute lymphoblastic leukemia
Announcement
Cellectis today hosts a R&D Day in New York City.
AI Summary
Cellectis today hosted its Research and Development Day in New York City. Company leaders and expert speakers presented the full Phase 1 data for lasme-cel (also called UCART22), an off-the-shelf CAR T therapy for patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). They also detailed the design of a pivotal Phase 2 trial, including patient criteria and clinical goals.
The presentation highlighted safety, efficacy signals and dosing strategies observed in Phase 1. It outlined plans to enroll more patients in the next trial and showed how lasme-cel could meet key regulatory requirements. Attendees discussed the potential market size and commercial strategy if the therapy gains approval.
The in-person event ran from 8:30 to 10:30 a.m. ET and was also live-streamed. A replay will be available on Cellectis’s website for anyone who could not attend.
Read Announcement- Drug:
- UCART22
- Announced Date:
- July 25, 2024
- Indication:
- For patients with relapsed or refractory CD22+ B-cell acute lymphoblastic leukemia
Announcement
Cellectis announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug (ODD)
AI Summary
Cellectis announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug and Rare Pediatric Disease Designation status to its UCART22 product candidate for treating acute lymphoblastic leukemia (ALL). ALL accounts for about 10% of all leukemia cases in the United States and is known for its rapid progression and high fatality rate if left untreated.
Mark Frattini, M.D., Ph.D., Chief Medical Officer at Cellectis, highlighted that this FDA designation underlines the potential of UCART22 to offer a new therapeutic option for patients who cannot undergo hematopoietic stem cell transplantation or have relapsed after previous treatments. The designations are expected to accelerate and reduce the development costs associated with UCART22, helping move this promising allogeneic CAR T-cell therapy closer to becoming a readily available treatment for ALL patients.
Read Announcement- Drug:
- UCART22
- Announced Date:
- July 25, 2024
- Indication:
- For patients with relapsed or refractory CD22+ B-cell acute lymphoblastic leukemia
Announcement
Cellectis announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) Status
AI Summary
Cellectis announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) Status to its UCART22 product candidate. The RPDD status is awarded to therapies addressing serious, life‐threatening diseases that mainly affect individuals from birth to 18 years old, which shows the FDA’s recognition of the need for new treatments in this area.
UCART22 is designed for the treatment of acute lymphoblastic leukemia (ALL), a fast-progressing disease responsible for about 10% of all leukemia cases in the United States and often fatal if left untreated. This designation is an important step in developing an allogeneic CAR T-cell therapy. It may help expedite the drug’s development and review process while potentially reducing costs. The achievement supports Cellectis' commitment to advancing promising new therapies for children with this challenging disease.
Read Announcement
TALEN® FDA Regulatory Events
TALEN® is a drug developed by Cellectis for the following indication: For triple negative breast cancer (TNBC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TALEN®
- Announced Date:
- September 3, 2024
- Indication:
- For triple negative breast cancer (TNBC)
Announcement
Cellectis today published a scientific article in Science Advances suggesting that TALEN®-edited MUC1 CAR T-cells could be a potential treatment option for advance-stage triple negative breast cancer (TNBC) patients with limited therapeutic options.
AI Summary
Cellectis recently published a study in Science Advances showing that TALEN®‐edited MUC1 CAR T-cells may offer a new treatment option for patients with advanced-stage triple-negative breast cancer (TNBC), a form of cancer with few current treatment choices. The research describes a multi-layered engineering strategy where CAR T-cells are modified using TALEN® and synthetic biology to improve their ability to fight tumors. These multi-armored CAR T-cells are designed with several edits—including PD1 knockout, tumor-specific IL12 release, and TGFBR2 knockout—to overcome the tumor’s immunosuppressive microenvironment.
The study’s preclinical tests in mouse models demonstrated that both intravenous and intratumoral delivery of these cells effectively reduced large, metastatic tumors. This approach may not only target primary tumors but also help control distant lesions, suggesting a promising new option for treating TNBC patients with limited alternatives.
Read Announcement
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