Blincyto (blinatumomab)

P1/2, N=100, Recruiting, Cardiff University | Not yet recruiting --> Recruiting

An example of this is blinatumomab, an FDA-approved BiTE structure for the treatment of B-cell acute lymphoblastic leukemia (B-ALL)...Ultimately, we present two promising TCR-BiTEs that are specific to two different HLAs (HLA:03:01 and HLA:11:01) targeting KRAS G12V, serving as valuable starting points for further evaluation and design in vitro. We validated the design of our TCR-BiTE structures through AlphaFold tools, free energy estimation methods, and molecular dynamics analysis, thereby also providing a potential computational pipeline that can be applied in the design of TCR-BiTE structures targeting other mutations in addition to KRAS G12V.

P2, N=222, Recruiting, National Cancer Institute (NCI) | Phase classification: P3 --> P2

P3, N=348, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting

P2, N=84, Recruiting, National Cancer Institute (NCI) | N=64 --> 84

For ALL, recommendations highlighted avoiding transplant in most Philadelphia chromosome-positive patients achieving minimal residual disease (MRD)-negativity by noting the high relapse risk with certain IKZF1, CDKN2A/B, and PAX5 aberrations, and administering blinatumomab regardless of MRD status in Philadelphia chromosome-positive and -negative ALL...Future directions include refining treatment sequencing, improving outcomes for high-risk subtypes, evaluating the role of HSCT in the era of novel therapies, and standardizing MRD assessment. This consensus report provides valuable expert insights to inform clinical practice and guide future research in leukemia.

P=N/A, N=80, Not yet recruiting, Institute of Hematology & Blood Diseases Hospital, China

In conclusion, MRD is a significant predictor of outcomes with DFCI. DFS and OS are high in MRD negative patients, without the use of blinatumomab.

P=N/A, N=100, Not yet recruiting, Institute of Hematology & Blood Diseases Hospital, China

P3, N=750, Not yet recruiting, Charite University, Berlin, Germany

BCGitis in infants with acute leukemia is a rare complication that is likely associated with chemotherapy-induced immunodeficiency or immune reconstitution following chemotherapy, immunotherapy, or HSCT. While manifestations are typically localized, careful management is required to prevent further complications. This is particularly crucial for patients undergoing HSCT, where prophylactic antimycobacterial therapy may be considered in selected high-risk settings.

In this context, monoclonal antibodies such as blinatumomab and inotuzumab ozogamicin (InO), used alone or in combination with reduced-intensity chemotherapy, have emerged as promising frontline approaches capable of deep remissions with improved tolerability. Across all treatment strategies, comprehensive geriatric assessment appears more informative than performance status alone in predicting tolerability and outcome, supporting its integration into trial design and routine decision-making. Overall, the refinement of immunotherapeutic approaches, coupled with biologically and geriatrically tailored treatment algorithms, offers the most promising avenue to improve long-term outcomes for older patients with ALL.