Cullinan Therapeutics Announces First Patient Dosed in Planned Registrational Phase 2 Study of CLN-049 in Relapsed/Refractory Acute Myeloid Leukemia
CLN-049 has received FDA Orphan Drug and Fast Track designations for relapsed/refractory acute myeloid leukemia.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Cullinan Therapeutics (CGEM) has dosed the first patient in its potentially registrational Phase 2 study of CLN-049 for relapsed/refractory acute myeloid leukemia.
The study evaluates the investigational treatment in patients whose leukemia has returned or resisted treatment after up to two prior therapy lines. Following an End-of-Phase 1 meeting with the U.S. FDA, it begins with dose optimization at two target dose levels, then advances to an expansion cohort without a comparison arm at the recommended Phase 2 dose. An exploratory cohort will evaluate patients with newly diagnosed TP53-mutated acute myeloid leukemia.
Cullinan expects a December update from the Phase 1 dose-escalation study in relapsed/refractory disease. In parallel, it is initiating a Phase 1/2 study of CLN-049 combined with azacitidine and venetoclax in newly diagnosed acute myeloid leukemia.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate pointFirst patient dosed advances CLN-049 into a potentially registrational Phase 2 study in relapsed/refractory acute myeloid leukemia.
- Moderate pointPhase 1/2 combination study is being initiated with azacitidine and venetoclax in newly diagnosed acute myeloid leukemia.
- Minor point. Forward-looking: it has not happened yet and may not happen.Exploratory cohort extends Phase 2 evaluation to newly diagnosed TP53-mutated acute myeloid leukemia.
- Minor point. Forward-looking: it has not happened yet and may not happen.Phase 1 update in relapsed/refractory acute myeloid leukemia is expected by Cullinan in December.
- Minor pointFDA Orphan Drug and Fast Track designations received for CLN-049 in relapsed/refractory acute myeloid leukemia.
Negative
- None.
Details
Market move: CGEM -4.13% vs previous close. Phase 2 first-patient dosing
On Oct 8, the day this news came out, the latest delayed price for CGEM is 4.13% below the previous close. Our momentum scanner has recorded 9 alerts for this stock so far that day. The latest delayed price is $14.98.
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Key Figures
- Patients dosed
- 1 patient
- CLN-049 Phase 2 study
- Prior therapy
- Up to two lines
- Relapsed/refractory AML study eligibility
- Target dose levels
- Two
- Phase 2 dose-optimization phase
- Phase 1 study update
- December
- Expected update on CLN-049 dose escalation in relapsed/refractory AML
Historical Context
-
Cullinan had planned registrational CLN-049 Phase 2 after an FDA meeting.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
pharmacokinetics medical
pharmacodynamics medical
open-label technical
dose escalation technical
orphan drug designation regulatory
fast track designation regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
CAMBRIDGE, Mass., Oct. 08, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, disease-modifying T cell engagers in autoimmune diseases and cancer, today announced that the first patient has been dosed in its pivotal Phase 2 study of CLN-049, a novel, investigational FLT3 T cell engager, in patients with relapsed/refractory acute myeloid leukemia (AML).
“Patients with relapsed or refractory AML continue to face poor outcomes and limited treatment options, underscoring the urgent need for new treatment approaches that can benefit a broad range of patients,” said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. “We believe CLN-049 has the potential to offer a novel immunotherapeutic approach for patients with AML. With this Phase 2 study now underway, we look forward to further evaluating the potential role of CLN-049 for this difficult-to-treat disease.”
The Phase 2 study is designed to evaluate CLN-049 in patients with relapsed/refractory AML who have received up to two lines of prior therapy. Following a successful End-of-Phase 1 meeting with the U.S. FDA, the potentially registrational study incorporates a brief dose-optimization phase evaluating two target dose levels of CLN-049, followed by seamless advancement to a single-arm expansion cohort at the recommended Phase 2 dose. The study also includes an exploratory cohort evaluating CLN-049 in patients with newly diagnosed TP53-mutated AML. The company expects to provide an update from the Phase 1 dose escalation study of CLN-049 in patients with relapsed/refractory AML in December.
In parallel, the company is initiating a Phase 1/2 study evaluating the combination of CLN-049, azacitidine, and venetoclax in patients with newly diagnosed AML.
About CLN-049
CLN-049 is a novel, investigational FLT3xCD3 T cell engager. CLN-049 is designed to target FLT3-expressing leukemia cells, offering a new immunotherapeutic approach for treating acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). CLN-049 binds to both mutated and non-mutated FLT3, allowing targeted action regardless of FLT3 mutational status, making the investigational treatment widely applicable to a broad population.
CLN-049 is being studied in a Phase 1/2, open-label, multicenter, multiple ascending dose study evaluating safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of intravenously (IV) administered CLN-049 in patients with relapsed/refractory AML or MDS (NCT05143996).
CLN-049 is also being studied in a Phase 1/2, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and PD of IV-administered CLN-049 in combination with azacitidine and venetoclax in patients with newly diagnosed AML (NCT07722767).
CLN-049 has received Orphan Drug designation and Fast Track designation from the U.S. FDA for the treatment of relapsed/refractory AML.
About Acute Myeloid Leukemia
Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow, and the most common form of acute leukemia in adults.1 It is characterized by the rapid growth of abnormal white blood cells that crowd out healthy cells, leading to infections, fatigue, and bleeding.2 Each year in the U.S., approximately 23,000 people are diagnosed with AML, and about half as many lives are lost to the disease.3 Globally, AML affects an estimated 145,000 people annually, with approximately 130,000 deaths.4
Despite recent advances, outcomes for patients with AML remain poor, particularly for those with relapsed or refractory disease, where five-year survival is
About Cullinan Therapeutics
Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company developing potential first- or best-in-class, disease-modifying T cell engagers for autoimmune diseases and cancer. Cullinan pursues promising therapeutic targets while leveraging core expertise in T cell engagers, which are established in oncology and are now advancing into autoimmune diseases. With a clinical-stage pipeline built on a rigorous scientific approach and purposeful innovation, Cullinan is advancing its mission to deliver new standards of care for patients. Learn more about Cullinan at https://cullinantherapeutics.com/, and follow Cullinan on LinkedIn and X.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding the company’s beliefs and expectations regarding: our clinical development plans and timelines for CLN-049, the clinical and therapeutic potential of CLN-049, the strategy of CLN-049, our research and development activities, and other statements that are not historical facts. The words “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “plan,” “potential,” “project,” “pursue,” “will,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events and are subject to known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the timing and results of regulatory submissions; the risk that any INDs, NDAs or other global regulatory submissions we may file with the United States Food and Drug Administration or other global regulatory agencies are not cleared or approved on our expected timelines, or at all; the success of our clinical trials and preclinical studies; the risks related to our ability to protect and maintain our intellectual property position; the risks related to manufacturing, supply, and distribution of our product candidates; the risk that any one or more of our product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; the effect of changes in global economic conditions, including uncertainties related to international trade policies, tariffs and supply chain dynamics on our business and operations; and the success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, including under the caption “Risk Factors” in our most recent Annual Report on Form 10-K and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except to the extent required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Moreover, except as required by law, neither the company nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made.
Contacts
Investors
Nick Smith
+1 401.241.3516
nsmith@cullinantx.com
Media
Rose Weldon
+1 215.801.7644
rweldon@cullinantx.com
References
- American Association for Cancer Research. (2025). Acute Myeloid Leukemia. https://www.aacr.org/patients-caregivers/cancer/acute-myeloid-leukemia/
- Leptidis, J., et al. (2014). Fatal cardiac tamponade as the first manifestation of acute myeloid leukemia. Am J Emerg Med 32(10). https://doi.org/10.1016/j.ajem.2014.02.045
- National Cancer Institute. (2025). Cancer Stat Facts: Leukemia — Acute Myeloid Leukemia (AML). https://seer.cancer.gov/statfacts/html/amyl.html
- Zhou, Y., et al. (2024). Global, regional, and national burden of acute myeloid leukemia, 1990–2021: A systematic analysis for the Global Burden of Disease Study 2021. Biomarker Research, 12(101). https://doi.org/10.1186/s40364-024-00649-y
- Moore, CG., et al. (2025). Treatment of Relapsed/Refractory AML—Novel Treatment Options Including Immunotherapy. Am J Hematol. (100)2. https://doi.org/10.1002/ajh.27584
- Shahzad, M., et al. (2024). What have we learned about TP53-mutated acute myeloid leukemia?. Blood Cancer J. 14(202). https://doi.org/10.1038/s41408-024-01186-5
- Kantarjian, H., et al. (2021). Acute myeloid leukemia: current progress and future directions. Blood Cancer J. 11(2). https://doi.org/10.1038/s41408-021-00425-3
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What milestone did Cullinan announce for the CLN-049 Phase 2 leukemia study?
The first patient has been dosed in the potentially registrational Phase 2 study of CLN-049. The study evaluates patients with relapsed/refractory acute myeloid leukemia who have received up to two prior lines of therapy.
When does Cullinan expect its next CLN-049 Phase 1 update?
Cullinan expects to provide an update in December from the CLN-049 Phase 1 dose-escalation study in patients with relapsed/refractory acute myeloid leukemia.
What FDA designations has Cullinan's CLN-049 received?
CLN-049 has received Orphan Drug designation and Fast Track designation from the U.S. FDA for treatment of relapsed/refractory acute myeloid leukemia.