AI brief of an SEC Form 8-K · Cullinan Therapeutics, Inc. (CGEM)

Cullinan Therapeutics reports CLN-049 AML data: 45% ORR at 12 µg/kg dose

Mixed Impact 3 of 5 other Written later

Cullinan Therapeutics disclosed updated Phase 1 dose escalation data for CLN-049, an investigational FLT3xCD3 T cell engager, in relapsed or refractory AML or MDS, and will present it at the 68th ASH Annual Meeting in December 2026. The data show an objective response rate of 45% at the 12 µg/kg target dose and cytokine release syndrome reduced to 26% under a two step-up dosing regimen, but the complete remission rates were 19% to 21% and the data come from a small, early-stage trial.

Key points

Study enrolled 87 patients (76 AML, 11 MDS) across 13 cohorts as of the data cutoff.
At 12 µg/kg, the CRc rate was 21% (6/29 patients, 2 CR) and the ORR was 45%; at 6 µg/kg, the CRc rate was 19% (3/16) and the ORR was 25%.
With a two step-up regimen, CRS incidence fell to 26% (7/27 patients) from 36% (13/36), and ICANS was 6% (5/87).

The filing

CompanyCullinan Therapeutics, Inc. (CGEM)

Form8-K, current report

Filed with the SECNov 4, 2026, 9:17 AM ET

Accession number0001193125-26-446348

Items reported: 7.01 Regulation FD Disclosure 8.01 Other Events

Read the filing on SEC.gov ↗

Written by AI on Nov 9, 2026, 11:43 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on November 04, 2026.

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