Imbioray's AML Cell Therapy Trial Slips 2 Years, 5 Months to July 2027
The Phase 1 IBR733 study in relapsed/refractory AML has 18 patients at one China site and no posted efficacy or safety data, leaving the delay itself as the only confirmed fact.
Executive Summary
- Imbioray pushed the primary completion date for its Phase 1 IBR733 cell injection trial in relapsed/refractory AML from February 1, 2025 to July 1, 2027, a slip of 2 years and 5 months, disclosed alongside a status change back to Recruiting Press Release+1Press ReleaseJul 2, 2026Study of IBR733 Cell Injection in Acute Myeloid LeukemiaNCT06234904.
- The trial's primary endpoints are safety measures, dose-limiting toxicity and adverse-event incidence, not efficacy, and no results are posted on ClinicalTrials.gov, so the delay changes timing but not what is known about whether IBR733 works NCT06234904Study of IBR733 Cell Injection in Acute Myeloid LeukemiaNCT06234904.
- Two tier-1 linked programs, CERo Therapeutics' CER-1236 and Crossbow Therapeutics' CBX-250, share the AML indication and cell-therapy modality but the model rates the readthrough 'Weak,' meaning this delay does not meaningfully signal trouble across the field.
- The AppliedXL model puts the endpoint-met probability at 2.4% and regulatory approval probability at 33.0%, both computed mainly from operational features like enrollment-per-arm and single-country trial design rather than mechanism data, since the drug's target remains undisclosed [AXL-MODEL].
The timing change
The trial, NCT06234904, is a Phase 1 study of IBR733 cell injection in adults 18 to 74 with relapsed or refractory acute myeloid leukemia who have failed at least two prior lines of therapy NCT06234904Study of IBR733 Cell Injection in Acute Myeloid LeukemiaNCT06234904. Imbioray disclosed on July 2, 2026 that the primary completion date moved to July 1, 2027 from an original target of February 1, 2025, a delay the sponsor's own briefing describes as "2 years and 5 months beyond the previously planned primary completion date" Press ReleasePress ReleaseJul 2, 2026. The same registry update flipped the trial's status from Unknown back to Recruiting, indicating the study is still active rather than abandoned NCT06234904Study of IBR733 Cell Injection in Acute Myeloid LeukemiaNCT06234904.
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
What the trial can and cannot show
The study enrolls 18 patients at a single site in China, in partnership with the First Affiliated Hospital of Soochow University, and uses an open-label, single-arm design with no comparator group NCT06234904Study of IBR733 Cell Injection in Acute Myeloid LeukemiaNCT06234904. Its two primary endpoints, incidence of dose-limiting toxicity through day 21 and incidence and severity of adverse events through 30 days post-dose, are safety measures NCT06234904Study of IBR733 Cell Injection in Acute Myeloid LeukemiaNCT06234904. Complete remission rate, objective remission rate, and overall survival are listed only as secondary endpoints NCT06234904Study of IBR733 Cell Injection in Acute Myeloid LeukemiaNCT06234904. A trial this size and design can establish a maximum tolerated dose and a safety signal; it cannot, on its own, establish whether IBR733 produces AML remissions.
No posted results yet
ClinicalTrials.gov shows no results posted for the study as of this update. That means the delay itself, not any disclosed efficacy or safety data, is the entirety of what this catalyst confirms. The dossier does not name a driver for the slip, whether slow enrollment, a manufacturing hold on the cell product, or a protocol amendment, and Imbioray's briefing document does not state one Press ReleasePress ReleaseJul 2, 2026.
Competitive and readthrough context
IBR733 sits among at least six other non-CAR cell therapy programs in AML tracked in the dossier, including BlueSphere Bio's BSB-1001, Orca Biosystems' Orca-T and Orca-Q, and Grit Biotechnology's GT737, none of which share IBR733's undisclosed molecular target NCT06234904Study of IBR733 Cell Injection in Acute Myeloid LeukemiaNCT06234904. The indication landscape carries a moderate score of 48 out of 100 with low data completeness, reflecting how little is publicly known across this class of therapies. Two tier-1 linked trials, CERo Therapeutics' CER-1236 (NCT06834282) and Crossbow Therapeutics' CBX-250 (NCT06994676), share the AML indication and cell-therapy modality, but the model classifies the readthrough from this delay as "Weak," meaning the slip does not signal a broader class-wide problem.
What the model rests on
The AppliedXL model puts the probability this trial's endpoint is met at 2.4% and the probability of eventual regulatory approval at 33.0% [AXL-MODEL]. The endpoint-met figure should be read against what the primary endpoint actually measures: a safety bar, not an efficacy bar, so it speaks to the odds the dose-finding and tolerability targets are cleared, not to whether IBR733 shows anti-leukemic activity. The read is driven overwhelmingly by operational-design features, enrollment per arm, number of countries, and treatment-area success-rate history, rather than by mechanism-fit or target-validation signals, which the model itself scores low given the undisclosed target [AXL-MODEL]. That domain mix means the number reflects trial structure more than any clinical judgment on IBR733 itself, and confidence in it should be held accordingly.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.