Cellectis (CLLS) FDA Approvals

Cellectis' Drugs in the FDA Approval Process

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 and UCART22. 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.

Data - June 11,2026

Phase 1

• Drug: Lasme-cel
• Announced Date: June 11, 2026
• Indication: in heavily pretreated patients with relapsed or refractory CD22+ B-cell acute lymphoblastic leukemia (r/r B-ALL)

Announcement

Cellectis presents final Phase 1 data from the BALLI-01 clinical trial evaluating lasme-cel, a CD22 directed allogeneic CAR-T therapy, in patients with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL), and preliminary data from the NATHALI-01 study evaluating eti-cel, a dual CD20 and CD22 directed CAR-T in relapsed/refractory B-cell non Hodgkin lymphoma (r/r B-NHL), at the European Hematology Association (EHA) 2026 Annual Congress.

AI Summary

Cellectis shared new EHA 2026 data for two CAR-T studies. In BALLI-01, lasme-cel for relapsed or refractory B-cell acute lymphoblastic leukemia showed strong final Phase 1 results in the target Phase 2 group: all 7 patients responded, 4 reached complete remission or complete remission with incomplete count recovery, and 75% of those tested were minimal residual disease negative. All patients then went on to stem cell transplant. The treatment also showed a manageable safety profile, with severe CRS, ICANS, and IEC-HS each seen in only a small number of patients and all cases resolved.

In NATHALI-01, early data for eti-cel in relapsed or refractory B-cell non-Hodgkin lymphoma showed activity in 14 heavily pretreated patients, most of whom had already received CD19 CAR-T therapy. The company said the results support studying weight-based alemtuzumab dosing and low-dose IL-2 to improve CAR-T expansion and response.

Upcoming presentations - May 12,2026

• 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.

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.

Provided Update - October 16,2025

• 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.