Cullinan Therapeutics' CLN-049 Shows 31% Complete Response Rate in R/R AML Patients
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 08 2025
0mins
Source: Newsfilter
- Clinical Data Update: Cullinan Therapeutics reported a 31% complete response (CR) rate in its Phase 1 study of CLN-049 for relapsed/refractory acute myeloid leukemia (R/R AML) patients, indicating significant potential for this therapy in heavily pretreated populations and the possibility of introducing new treatment options in the field.
- FDA Fast Track Designation: CLN-049 has recently received Fast Track designation from the U.S. FDA, highlighting the therapy's promising prospects in treating R/R AML, which is expected to expedite its clinical development process to meet the urgent needs of patients requiring new therapies.
- Favorable Safety Profile: Among the 45 patients, CLN-049 demonstrated a favorable safety profile, with the most common treatment-emergent adverse events being cytokine release syndrome (35.6%), predominantly Grade 1 or 2, indicating the therapy's feasibility and patient tolerability in clinical applications.
- Future Development Plans: Cullinan Therapeutics plans to expand its study cohorts in early 2026, continuing dose escalation studies to further validate the efficacy and safety of CLN-049, aiming to provide more treatment options for AML patients.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy CGEM?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on CGEM
Wall Street analysts forecast CGEM stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for CGEM is 31.71 USD with a low forecast of 24.00 USD and a high forecast of 38.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
9 Analyst Rating
9 Buy
0 Hold
0 Sell
Strong Buy
Current: 11.920
Low
24.00
Averages
31.71
High
38.00
Current: 11.920
Low
24.00
Averages
31.71
High
38.00
About CGEM
Cullinan Therapeutics, Inc. is a biopharmaceutical company. It has built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in autoimmune diseases and cancer. Its portfolio includes a range of modalities. Its pipeline includes CLN-978, CLN-619, Zipalertinib (CLN-081/TAS6417), CLN-049, and CLN-617. CLN-978 is a CD19xCD3 T cell engager being developed for autoimmune diseases. CLN-619 is a monoclonal antibody that stabilizes expression of MICA/B on the tumor cell surface to promote tumor cell lysis mediated by cytotoxic innate and adaptive immune cells. Zipalertinib (CLN-081/TAS6417) is an orally available small-molecule, irreversible epidermal growth factor receptor inhibitor. CLN-049 is a FLT3xCD3 T cell engaging bispecific antibody. CLN-617 is a fusion protein combining two potent antitumor cytokines, interleukin-2 and interleukin-12 with tumor retention domains for the treatment of solid tumors.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Major Stocks on the Rise Monday: Paramount Skydance, Wave Life Sciences, Ocular Therapeutix, Carvana, and More
U.S. Stock Market Performance: U.S. stocks declined, with the Dow Jones dropping over 200 points on Monday, while several companies saw significant gains in their share prices.
Paramount's Acquisition Move: Paramount Skydance Corporation's shares surged nearly 10% after announcing a $30 per share all-cash tender offer to acquire Warner Bros. Discovery, valuing the deal at $108.4 billion.
Biotech Stock Gains: Wave Life Sciences and Structure Therapeutics experienced remarkable increases of 129.1% and 100.5%, respectively, following positive clinical trial results for their obesity treatments.
Other Notable Stock Movements: Companies like Fulcrum Therapeutics and Kymera Therapeutics also saw substantial share price increases due to promising clinical trial data, while Carvana announced its inclusion in the S&P 500, boosting its stock by 11.6%.
Continue Reading
Cullinan Therapeutics' CLN-049 Shows 31% Complete Response Rate in R/R AML Patients
- Clinical Trial Results: Among 45 patients treated with CLN-049, a complete response (CR/CRh) rate of 31% was observed at the highest dose of 12 µg/kg, indicating the therapy's efficacy in heavily pretreated acute myeloid leukemia (AML) patients and potentially offering new treatment options in this area.
- Favorable Tolerability: CLN-049 demonstrated a favorable safety profile across all assessed doses, with 35.6% of patients experiencing cytokine release syndrome (CRS), primarily Grade 1 or 2, which did not lead to treatment discontinuation, suggesting its potential for clinical application.
- FDA Fast Track Designation: CLN-049 has recently received Fast Track designation from the U.S. FDA, underscoring its potential in treating relapsed/refractory AML patients and likely accelerating its clinical development timeline.
- Future Development Plans: Cullinan Therapeutics will host an investor event on December 8, 2025, to share the latest clinical data on CLN-049, further enhancing communication with investors and boosting market confidence.
Continue Reading