Cellectis Presents Final Phase 1 Results of Lasme-cel and Preliminary Results on Eti-cel at EHA 2026 Congress
Rhea-AI Summary
Cellectis (NASDAQ: CLLS) reported final Phase 1 BALLI-01 results for lasme-cel in relapsed/refractory B-cell acute lymphoblastic leukemia and preliminary NATHALI-01 data for eti-cel in relapsed/refractory B-cell non-Hodgkin lymphoma at EHA 2026.
Lasme-cel achieved 100% ORR (7/7) in the target Phase 2 population, with 57% CR/CRi and 75% MRD-negative among responders; all proceeded to HSCT. ≥grade 3 CRS and ICANS each occurred in 4% of patients, IEC-HS in 2%, all resolving. Eti-cel showed 88% ORR and 63% CR in the optimal dose cohort, with alemtuzumab exposure and low-dose IL-2 being explored to optimize lymphodepletion and CAR-T expansion. Both BALLI-01 pivotal Phase 2 and NATHALI-01 Phase 1 are open for recruitment, with key analyses expected in Q4 2026.
AI-generated analysis. Not financial advice.
Positive
- Lasme-cel target Phase 2 population ORR 100% (7/7) in r/r B-ALL
- Lasme-cel CR/CRi 57% with 75% MRD-negative among responders; all bridged to HSCT
- Serious CRS and ICANS each reported in 4% of patients; IEC-HS in 2%; all resolved
- Eti-cel optimal dose cohort ORR 88% and CR 63% in r/r B-NHL
- Correlation of alemtuzumab exposure with eti-cel expansion and response supports weight-based dosing strategy
- Key BALLI-01 interim and full NATHALI-01 Phase 1 data expected in Q4 2026
Negative
- Grade ≥3 CRS, ICANS and IEC-HS events occurred in eti-cel and lasme-cel studies, despite full resolution
News Market Reaction – CLLS
On the day this news was published, CLLS declined 2.83%, reflecting a moderate negative market reaction. Argus tracked a trough of -11.2% from its starting point during tracking. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $7M from the company's valuation, bringing the market cap to $230.04M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
CLLS was up 6.35% while key biotech peers like ENGN, FDMT and KRRO were down between about 3–5%, suggesting a stock-specific move rather than a sector-wide shift.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| May 12 | EHA data preview | Positive | -0.5% | Announced upcoming EHA 2026 presentations for lasme-cel and eti-cel datasets. |
Limited tag-specific history: the prior clinical-trial announcement around EHA data saw a small negative move despite positive messaging.
Over recent months, Cellectis has focused on advancing lasme‑cel and eti‑cel. A prior May 12, 2026 clinical‑trial release previewed EHA 2026 presentations of full Phase 1 BALLI‑01 and preliminary NATHALI‑01 data, with a modest -0.5% price reaction. Since then, regulatory momentum built with RMAT status for lasme‑cel and the pivotal Phase 2 BALLI‑01 opening. Today’s detailed Phase 1 outcomes and NATHALI‑01 updates represent execution on those previously signaled plans.
Historical Comparison
Past clinical-trial news around lasme-cel and eti-cel, including the EHA 2026 preview, produced an average move of about -0.5%, showing modest, mixed trading around similar data updates.
This announcement progresses from the May 2026 EHA preview to full Phase 1 BALLI‑01 results and deeper NATHALI‑01 insights, reinforcing the advancement of both lasme‑cel and eti‑cel programs.
Regulatory & Risk Context
The company has an effective F-3 shelf filed on 2025-07-02 that remains active through 2028-07-02, with 0 recorded usage events to date, indicating authorized but so far untapped capacity for future securities issuance.
Market Pulse Summary
This announcement details final Phase 1 BALLI‑01 results for lasme‑cel with 100% ORR in the target Phase 2 group and encouraging safety, alongside promising NATHALI‑01 eti‑cel responses at optimal dose. It builds on prior EHA 2026 previews and the RMAT designation for lasme‑cel. Investors may track upcoming Q4 2026 readouts, pivotal Phase 2 progress, and capital plans under the active F-3 shelf when assessing long-term implications.
Key Terms
allogeneic car-t medical
cytokine release syndrome medical
immune effector cell-associated neurotoxicity syndrome medical
immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome medical
minimal residual disease medical
hematopoietic stem cell transplantation medical
interleukin 2 medical
phase 1 medical
AI-generated analysis. Not financial advice.
NEW YORK, June 11, 2026 (GLOBE NEWSWIRE) -- 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, 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.
BALLI-01 clinical trial evaluating lasme-cel in r/r B-ALL - Oral Presentation
The BALLI-01 final Phase 1 data will be presented as an oral presentation by Nitin Jain, M.D., Professor of Medicine, Department of Leukemia at the University of Texas MD Anderson Cancer Center in Houston, TX.
45 patients in third line and beyond (3L+) were treated in the BALLI-01 study. 15 patients were treated at the recommended Phase 2 dose and 7 in the target Phase 2 population. Patients were heavily pretreated with those in the target Phase 2 population receiving a median of 5 prior lines of therapy (Range 2-11). Almost all patients were previously treated with blinatumumab (
Final Phase 1 data
In the target Phase 2 population
An overall response rate (ORR) of
All patients subsequently proceeded to HSCT.
Lasme-cel demonstrated a manageable safety profile
- Cytokine release syndrome (CRS) ≥ grade 3 occurred in
4% of patients. - Immune effector cell-associated neurotoxicity syndrome (ICANS) ≥ grade 3 occurred in
4% of patients. - Immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) ≥ grade 3 occurred in
2% of patients.
All CRS, ICANS, and IEC-HS resolved.
“These final Phase 1 results are particularly meaningful for a patient population that has very limited treatment options” said Nitin Jain, M.D., Professor of Medicine, Department of Leukemia at UT MD Anderson. “Being able to achieve deep remissions in these patients and allowing them to subsequently receive an HSCT is promising. We look forward to accelerating accrual into the ongoing Pivotal Phase 2 study and bringing this treatment to patients.”
The Pivotal Phase 2 BALLI-01 trial is open for recruitment. Eligible patients and treating physicians are encouraged to visit BALLI-01 (NCT04150497) or contact Cellectis at clinicaltrials@cellectis.com for information and participating sites. The first interim analysis is expected in Q4 2026.
Oral Presentation: Safety and efficacy of UCART22 in heavily pretreated patients with relapsed or refractory CD22+ B-cell acute lymphoblastic leukemia (B-ALL): results of the Phase 1 BALLI-01 trial
Date/Time: Saturday, June 13 at 5:15 - 6:30pm, local time
Session Title: Advances in the treatment of lymphoblastic leukemia
Session Room: K1
Abstract Number: 4689
Note: presentation slides will be uploaded to Cellectis’ website concurrently with the live presentation.
NATHALI-01 clinical trial evaluating eti-cel in r/r B-NHL - Poster Presentation
The NATHALI-01 preliminary data on the role of alemtuzumab in optimizing responses will be presented as a poster by Professor Emmanuel Bachy, M.D., Ph.D., Department of Hematology, Hospices Civils de Lyon, France.
Eti-cel is a highly differentiated product being the first allogeneic dual CAR-T targeting both CD20 and CD22, for patients with r/r B-NHL.
As of the February 2026 data cutoff, 14 patients with r/r B-NHL had been treated across three dose levels, in a heavily pre-treated population with a median of 3 prior lines of therapy,
In the optimal dose cohort, ORR and complete response (CR) were
These findings provide a scientific rationale for the implementation of a weight-based alemtuzumab dosing regimen, currently under investigation to optimize lymphodepletion. Additionally, subcutaneous low-dose IL-2 is being investigated to further enhance eti-cel expansion and treatment response.
“These encouraging data demonstrate that not only can eti-cel drive responses in a very difficult-to-treat population, but that by optimizing exposure to alemtuzumab we may be able to create a favorable environment for CAR-T expansion and persistence." said Professor Emmanuel Bachy, M.D., Ph.D., Department of Hematology, Hospices Civils de Lyon, France.
The NATHALI-01 study is open for recruitment with the full Phase 1 clinical data expected in Q4 2026.
Poster Presentation: Alemtuzumab exposure and sustained IL-2 drive UCART20x22 expansion and clinical response in adults with relapsed or refractory B-cell non-Hodgkin lymphoma: NATHALI-01 study
Date/Time: Saturday, June 13 at 6:45 - 7:45pm, local time
Session: Poster Session 2
Poster Number: 4758
Note: poster presentation will be uploaded to Cellectis’ website at the opening of the poster session.
About Cellectis
Cellectis is a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies. The company utilizes an allogeneic approach for CAR T immunotherapies in oncology, pioneering the concept of off-the-shelf and ready-to-use gene-edited CAR T-cells to treat cancer patients, and a platform to develop gene therapies in other therapeutic indications. With its in-house manufacturing capabilities, Cellectis is one of the few end-to-end gene editing companies that controls the cell and gene therapy value chain from start to finish. Cellectis’ headquarters are in Paris, France, with locations in New York and Raleigh, NC. Cellectis is listed on the Nasdaq Global Market (ticker: CLLS) and on Euronext Growth (ticker: ALCLS). To find out more, visit www.cellectis.com and follow Cellectis on LinkedIn and X.
Cautionary Statement
This press release contains “forward-looking” statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as “can,” “expected,” ”look-forward,” “may” or the negative of these and/or similar expressions. These forward-looking statements are based on our management’s current expectations and assumptions and on information currently available to management. Forward-looking statements include statements about the potential of the pivotal Phase 2 BALLI-01 trial to be a registrational phase, the advancement, timing and progress of clinical trials (including with respect to patient enrollment and follow-up), the timing of our presentation of data and submission of regulatory filings, the sufficiency of cash to fund operations, the potential benefit of our product candidates. These forward-looking statements are made in light of information currently available to us and are subject to significant risks and uncertainties, including with respect to the numerous risks associated with biopharmaceutical product candidate development. Among these are significant risks that the BALLI-01 Phase 1 data may not be validated by data from later stage of clinical trials and that our product candidate may not receive regulatory approval for commercialization. Particular caution should be exercised when interpreting results from Phase 1 studies and results relating to a small number of patients – such results should not be viewed as predictive of future results. Furthermore, many other important factors, including those described in our Annual Report on Form 20-F as amended and in our annual financial report (including the management report) for the year ended December 31, 2025 and subsequent filings Cellectis makes with the Securities Exchange Commission from time to time, which are available on the SEC’s website at www.sec.gov, as well as other known and unknown risks and uncertainties may adversely affect such forward-looking statements and cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.
For further information on Cellectis, please contact:
Media contacts:
Pascalyne Wilson, Director, Communications, + 33 (0)7 76 99 14 33, media@cellectis.com
Patricia Sosa Navarro, Chief of Staff to the CEO, +33 (0)7 76 77 46 93
Investor Relations contact:
Arthur Stril, Chief Financial Officer & Chief Business Officer, investors@cellectis.com
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