The strong Phase 1 efficacy and safety data support the ongoing pivotal Phase 2 BALLI-01 trial, with interim analysis in Q4 2026 as the next major catalyst. Monitor for patient enrollment updates and potential partnership interest given the differentiated allogeneic platform.
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Executive Summary
Cellectis presented final Phase 1 data for lasme-cel (CD22 allogeneic CAR-T) in r/r B-ALL at EHA 2026, showing 100% ORR and 57% CR/CRi in the target Phase 2 population (n=7), with a manageable safety profile. Preliminary Phase 1 data for eti-cel (dual CD20/CD22 CAR-T) in r/r B-NHL showed 88% ORR and 63% CR in the optimal dose cohort. Both trials are open for recruitment with interim/full data expected in Q4 2026.
Key Facts
- BALLI-01 final Phase 1: 100% ORR (7/7) and 57% CR/CRi (4/7) in target Phase 2 population of heavily pretreated r/r B-ALL patients (median 5 prior lines).
- 75% of responders achieved MRD-negative status; all proceeded to HSCT.
- Safety profile manageable: ≥Grade 3 CRS 4%, ICANS 4%, IEC-HS 2%; all resolved.
- Pivotal Phase 2 BALLI-01 open for recruitment; first interim analysis expected Q4 2026.
- NATHALI-01 preliminary data: 88% ORR and 63% CR in optimal dose cohort for r/r B-NHL; full Phase 1 data expected Q4 2026.
- Eti-cel is first allogeneic dual CAR-T targeting CD20 and CD22.
Financial Impact
No financial figures provided; clinical-stage company with no approved products or revenue.
Risk Factors
- Phase 1 data from small patient numbers (n=7 target population) may not predict Phase 2 or registrational outcomes.
- Competition from approved CD19 and CD22 CAR-T therapies (e.g., Kymriah, Breyanzi, Tecartus) and other allogeneic programs.
- Cash runway and need for additional financing to complete pivotal trials.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3310207 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Sep 14, 2026 6w ago | 6-K | $1.83 | awaiting T+60 | — | $0.9670 (+47.16%) |
Sep 11, 2026 6w ago | Press Release | $1.83 | awaiting T+60 | — | $0.9670 (−47.16%) |
Aug 6, 2026 11w ago | Press Release | $2.84 | awaiting T+60 | — | $0.9670 (−65.89%) |
Jun 29, 2026 17w ago | Court Ruling | $3.00 $1.43 | ▼ −52.33% | ▼ −55.32% | $0.9670 (−67.77%) |
Jun 25, 2026 17w ago | 6-K | $2.83 $1.51 | ▼ −46.64% | ▼ −52.75% | $0.9670 (−65.83%) |
Jun 25, 2026 17w ago | 6-K | $2.83 $1.51 | ▼ −46.64% | ▼ −52.75% | $0.9670 (−65.83%) |
Jun 11, 2026 19w ago | Press Release | $3.09 $3.24 | ▲ +4.85% | ▲ +0.46% | $0.9670 (−68.71%) |
Jun 9, 2026 19w ago | 6-K | $3.18 $3.32 | ▲ +4.40% | ▼ −2.18% | $0.9670 (−69.59%) |
May 12, 2026 23w ago | 6-K | $3.96 $2.69 | ▼ −32.07% | ▼ −36.45% | $0.9670 (−75.58%) |
May 4, 2026 25w ago | 6-K | $3.76 $2.85 | ▼ −24.20% | ▼ −26.94% | $0.9670 (−74.28%) |
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