Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
B-cell Acute Lymphoblastic Leukemia
No strong warning signs right now. The score counts warning signs; it is not a prediction.
Why this score
- +25
Changed the trial's main goal
Since Nov 9, 2026 · was worth 25, fading over time
- +10
Pushed back a key date by about 17 months
Since Nov 9, 2026 · was worth 10, fading over time
Score over time
- Stage
- Phase 1/2
- Patients
- 45 (final count)
- Started
- Oct 14, 2019
- Main results expected
- Sep 16, 2026
- Fully finished
- Dec 2027
- Results posted
- not yet
What counts as success
The trial's main goal(s), called the “primary outcome.”
Incidence of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicities (DLTs) throughout the study in relation to UCART22 and/or lymphodepletion
Measured over: 24 months
Percentage of participants achieving a complete response (CR) or CR with incomplete hematologic recovery (CRi) according to the Response Criteria for acute lymphoblastic leukemia (ALL) assessed by independent response review committee
Measured over: Within 3 months at Day 28, Day 56, Day 84
Changes Tremor has spotted
Status changed: Signing up patients → Running, no new patients. Usually normal progress.
Spotted
Pushed back the final finish date by about 17 months: Jun 30, 2026 → Dec 2027.
Cellectis, a company that makes cell-based cancer treatments, pushed back the expected finish date of its UCART22 leukemia study from June 30, 2026 to December 2027, about 17 months later. Investors often watch for delays like this because they can hint that a study is running slower than planned, which may raise questions about when results will arrive. A date change like this also has ordinary explanations, such as scheduling adjustments or a steady pace of follow-up, and the company hasn't said why it moved, so on its own it doesn't prove anything about how the study is going.
AI-written from the facts above
Spotted
Moved the main results date slightly later: Jun 30, 2026 → Sep 16, 2026.
Spotted
Slightly lowered the number of patients, from 52 to 45.
Spotted
Changed the trial's main goal (what counts as success).
Cellectis changed what the UCART22 leukemia trial counts as success, adding a goal about how many patients get a complete response (the leukemia going into remission) on top of the earlier focus on safety and side effects. Investors often watch changes like this because a trial that adds or shifts its main goal can signal that the company is rethinking what it expects to show, which can point to worry about the original plan. The change can also have ordinary reasons, such as adding a measure that regulators or researchers asked for, so on its own it doesn't prove anything about how the drug is doing.
Show details (technical version)
Score inputs
- primary_outcome_changed: base 25, now 25, since 2026-11-09, fades (half-life)
- date_delayed: base 10, now 10, since 2026-11-09, fades (half-life)
Raw record changes
- 2026-11-09 15:36 UTC · status_changed · overall_status
old: "RECRUITING"
new: "ACTIVE_NOT_RECRUITING" - 2026-11-09 15:36 UTC · date_delayed · completion_date
old: "2026-06-30"
new: "2027-12"
details: {"months":17} - 2026-11-09 15:36 UTC · date_small_change · primary_completion_date
old: "2026-06-30"
new: "2026-09-16"
details: {"months":2.6} - 2026-11-09 15:36 UTC · enrollment_small_cut · enrollment
old: 52
new: 45
details: {"new_type":"ACTUAL","old_type":"ESTIMATED","percent_cut":13.5} - 2026-11-09 15:36 UTC · primary_outcome_changed · primary_outcomes
old: [{"measure":"Incidence of AE/SAE/DLT [Safety and Tolerability]","timeFrame":"24 Months","description":"Incidence, nature, and severity of adverse events and serious adverse events (SAEs) throughout the study in relation to UCART22 and/or lymphodepletion"},{"measure":"Dose escalation part: Occurrence of Dose Limiting Toxicities (DLTs)","timeFrame":"Up to D28 post initial UCART22 infusion"}]
new: [{"measure":"Incidence of adverse events (AEs), serious adverse events (SAEs), and dose limiting toxicities (DLTs) throughout the study in relation to UCART22 and/or lymphodepletion","timeFrame":"24 months"},{"measure":"Percentage of participants achieving a complete response (CR) or CR with incomplete hematologic recovery (CRi) according to the Response Criteria for acute lymphoblastic leukemia (ALL) assessed by independent response review committee","timeFrame":"Within 3 months at Day 28, Day 56, Day 84"}]
details: {"added":["incidence of adverse events aes serious adverse events saes and dose limiting toxicities dlts throughout the study in relation to ucart22 and or lymphodepletion","percentage of participants achieving a complete response cr or cr with incomplete hematologic recovery cri according to the response criteria for acute lymphoblastic leukemia all assessed by independent response review committee"],"removed":["dose escalation part occurrence of dose limiting toxicities dlts","incidence of ae sae dlt safety and tolerability"]}
Trial ID NCT04150497 · record last updated 2026-11-09 · checked 2026-11-09 15:42 UTC