P1, N=192, Terminated, Jiangsu Simcere Pharmaceutical Co., Ltd. | Trial completion date: Jan 2026 --> May 2024 | Recruiting --> Terminated | Trial primary completion date: Apr 2025 --> May 2024; An internal business decision, not based on safety or regulatory considerations.

P1, N=90, Recruiting, Nkarta, Inc.

P1, N=48, Recruiting, Century Therapeutics, Inc. | N=30 --> 48

P1/2, N=263, Active, not recruiting, Salubris Biotherapeutics Inc | Recruiting --> Active, not recruiting

P1, N=0, Withdrawn, M.D. Anderson Cancer Center | N=21 --> 0 | Trial completion date: Mar 2030 --> Oct 2024 | Not yet recruiting --> Withdrawn | Trial primary completion date: Mar 2028 --> Oct 2024

Differences in common γ-chain cytokine receptor expression between PD-1+ and TIM-3+ T cells may reflect functional dissimilarity of these cell subsets. Checkpoint blockade appears to alleviate lymphopenia-induced proliferation of PD-1+ T cells but may raise the possibility of immune-mediated adverse events.

P1/2, N=78, Not yet recruiting, SUNHO（China）BioPharmaceutical CO., Ltd.

P1, N=21, Recruiting, Nkarta, Inc.

P1, N=26, Recruiting, Century Therapeutics, Inc. | Not yet recruiting --> Recruiting

P1, N=6, Recruiting, Columbia University

P1/2, N=263, Recruiting, Salubris Biotherapeutics Inc | N=149 --> 263

P1, N=21, Active, not recruiting, M.D. Anderson Cancer Center | N=30 --> 21 | Recruiting --> Active, not recruiting

P1, N=150, Recruiting, Nkarta Inc. | Trial primary completion date: Dec 2023 --> Aug 2024

P1/2, N=52, Recruiting, Obsidian Therapeutics, Inc. | N=32 --> 52

P1, N=26, Not yet recruiting, Century Therapeutics, Inc.

Our findings identified TIGIT as a promising therapeutic target for LUAD. LUAD could benefit more from the combined therapy of IL-15 stimulation and TIGIT blockade.

P1, N=108, Recruiting, Jiangsu Simcere Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting

The ability to isolate functional NK-EVs on a large scale and use them with platinum-based drugs may lead to new clinical applications. The results of the present study suggest the possibility of the combination of NK-cell-derived EVs and CBP as a viable immunochemotherapeutic strategy for resistant cancers.

P1, N=108, Not yet recruiting, Jiangsu Simcere Pharmaceutical Co., Ltd.

Treatment of patients with GC/GEJC with GEN-001 in combination with avelumab in the ≥ 3L setting showed promising antitumor activities with an overall manageable safety profile. The results from this trial will be updated about its effects on clinical outcome, including survival, safety, and biomarker findings. Clinical trial information: NCT05419362.

Two study arms shows similar data respect to clinical outcome. Patients infused with IL-15-stimulated NK cells showed similar toxicity to the alloreactive NK group. According to dose escalation, we observed no association between increased toxicity and increased number of infused NK cells.

The immune stimulatory mechanisms triggered by NL-201 and RT resulted in superior tumor growth inhibition and survival benefit in both localized and metastatic cancers. Our results support further preclinical and clinical investigation of this novel synergism regimen in locally advanced and metastatic settings.

Cycles 1 and 2 included three days of standard Fludarabine and Cyclophosphamide lymphodepletion (LDC), cycles 3 and 4 were given with no LDC. The treatment was associated with changes in tumor microenvironment within 8 days post-infusion, augmentation of adaptive T cell responses, and tumor shrinkage. Updated data will be presented at the conference.

P2, N=42, Active, not recruiting, Genome & Company | Recruiting --> Active, not recruiting

P2, N=148, Recruiting, Genome & Company | Not yet recruiting --> Recruiting

P1/2, N=32, Recruiting, Obsidian Therapeutics, Inc. | Active, not recruiting --> Recruiting

Nanostring analysis of paired biopsies from the PR pts demonstrated upregulation of integrin signaling pathway, antigen-presenting MHC (HLA-DQA1 and HLA-DRB1) and chemokine receptor (CMKLR1) genes, and activation of CD8+ T cells. Conclusions Monotherapy with VG2025 demonstrated activity with a well-tolerant safety profile in pts with advanced solid tumors that progressed after standard of care therapy.

P1/2, N=32, Active, not recruiting, Obsidian Therapeutics, Inc.

Response will be assessed every 9 weeks per RECIST v1. 1.

P2, N=42, Recruiting, Genome & Company | Trial completion date: Sep 2024 --> Dec 2024 | Trial primary completion date: Sep 2024 --> Dec 2024

Conclusions At the dose levels evaluated to date, JK08 has been well tolerated, demonstrating preliminary disease stability & anticipated modulation of target immune cell populations in aggressive heavily pre-treated solid tumors. These results provide an initial characterization of JK08 biology & activity.

P1/2, N=140, Recruiting, SUNHO（China）BioPharmaceutical CO., Ltd. | Not yet recruiting --> Recruiting

In addition to safety and efficacy endpoints, the trial will evaluate exploratory PK, immunogenicity and pharmacodynamic endpoints including evaluations of tumor cfDNA, iNK tumor trafficking and serum cytokines. Clinical trial information: NCT05336409.

Monotherapy activity was observed with an acceptable safety profile in heavily pretreated pts with advanced solid tumors. Clinical trial information: NCT05266612.

P1; N=192; Recruiting; Sponsor:Jiangsu Simcere Pharmaceutical Co., Ltd.

Importantly, TriKE triggered NK cell responses from patients at all stages of disease and treatment, suggesting TriKE can enhance current therapies. These pre-clinical studies suggest mesothelin-targeted TriKE has the potential to overcome the immunosuppressive environment of NSCLC to treat disease.

Four tumor specific expansion cohorts will be initiated once dose and schedule are established from dose escalation and include melanoma, breast cancer, colorectal cancer, and a basket of advanced solid tumors. Response will be assessed every 9 weeks per RECIST v1.1.

CNTY-101 is an induced Pluripotent Stem Cell (iPSC) derived Chimeric Antigen Receptor (CAR) NK cell clinical candidate for the treatment of B-cell malignancies...In addition, we identify biomarkers measured during the differentiation process that are correlated with functional performance, such as the level of CD94 surface expression and tumor killing. Finally, we discuss the application of functional multi-omics to candidate clone nomination for Century Therapeutics’ pipeline of future products.

The indications of IAP0971 include lung cancer, cervical cancer, head and neck squamous cell carcinoma, liver cancer, lymphoma, and other malignant tumors. A Phase I/IIa clinical trial to evaluate the safety, tolerability and preliminary efficacy of IAP0971 in patients with locally advanced or metastatic malignant tumors is currently on-going (NCT05396391).

We previously showed that melanoma TILs engineered to express membrane-bound IL15 (mbIL15) under the control of the ligand acetazolamide (ACZ) can achieve IL2-independent expansion during manufacturing, antigen-independent persistence in vitro and anti-tumor efficacy in vivo. Unlike unengineered TILs, cytoTIL15 cells + ACZ persisted in an antigen-free setting without IL2, were cytotoxic to autologous PDc and released IFNγ in response to autologous PDx tumor digest. Taken together, these data show that IL2-independent, fully functional cytoTIL15 cells can successfully be generated from tumors such as NSCLC, HNSCC & TNBC, which afflict large numbers of patients.

IAP0971 has demonstrated a favorable safety profile and potent anti-tumor activities in vivo. A Phase I/IIa clinical trial to evaluate the safety, tolerability and preliminary efficacy of IAP0971 in patients with advanced malignant tumors is on-going (NCT05396391).

These iiT8 cells integrate the innate natural killer cell activity with adaptive T cell longevity, promising an interesting therapeutic potential. Our study demonstrates that innate T cells, albeit of limited clinical applicability given their low frequency, can be efficiently generated from peripheral blood and applied for adoptive transfer, CAR therapy, or combined with therapeutic antibodies.