Treatment for advanced solid tumors using engineered T cells

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety, efficacy, and pharmacokinetics of a novel T-cell therapy targeting KRAS G12V/G12D mutations in patients with advanced solid tumors. It involves an open-label, two-cohort design with a focus on patients who have not responded to standard systemic treatments. Participants will receive a single infusion of autologous T cells engineered to recognize specific tumor mutations, with the study aiming to gather preliminary efficacy results alongside safety data.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Age between 18-75 years
* Diagnosis of pathologically or histologically confirmed unresectable or advanced solid tumor, and have no standard treatment options available or unable to tolerate the currently available standard treatments
* HLA-A11:01positive Tumor has KRAS G12V (NW-301V cohort) or G12D (NW-301D cohort) mutation \* Adequate organ function prior to apheresis and lymphodepleting chemotherapy
* ECOG performance status of 0-1
* At least one tumor lesion measurable according to RECIST 1.1 (Additional protocol-defined Inclusion criteria may apply.)

Key Exclusion Criteria:

* Received the following treatments: Cytotoxic chemotherapy within 2 weeks prior to apheresis and within 1 week prior to lymphodepletion; Treatment with antibodies (including but not limited to those with monoclonal antibodies and immune checkpoint inhibitors) or other biologic therapy within 2 weeks prior to apheresis and within 1 week prior to lymphodepletion; Immunosuppressive agents (e.g., calcineurin inhibitors, methotrexate or other chemotherapeutic agents, mycophenolate mofetil, rapamycin, thalidomide, immunosuppressive antibodies such as anti-TNF, anti-IL-6, or anti-IL-6 receptor) within 2 weeks prior to apheresis and within 1 week prior to lymphodepletion
* History of allergic reactions to cyclophosphamide, fludarabine, or any other chemical or biological components of the drugs used in this study
* History of chronic or recurrent severe autoimmune disease, or active immune disease requiring treatment with steroids or other immunosuppressive agents within 1 year prior to enrollment\* Have symptomic CNS metastases
* Have leptomeningeal disease or carcinomatous meningitis
* Have ongoing or active infection
* Active infections with HIV, HBV, HCV, or syphilis
* Breastfeeding or pregnant (Additional protocol-defined Exclusion criteria may apply.)

Where it's running

• Tianjin Medical University Cancer Institute and Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Rui Liu
• Email: rui.liu@neowisebio.com
• Phone: 0512-67991566

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Carbon nanoparticle‑loaded iron for advanced solid tumors

  This test uses direct injections of a carbon nanoparticle‑loaded iron medicine (CNSI‑Fe) to see if it can shrink tumors in adults with advanced solid cancers who have no effective standard treatment options.

  Recruiting at 4 sites Phase 1/2 Sichuan Enray Pharmaceutical Sciences Company · Beijing, Beijing Municipality and 8 other locations · NCT07433283

• RGL-270 vaccine alone or with adebelimab to lower risk of cancer coming back after surgery

  This phase I trial will test whether a personalized mRNA vaccine called RGL-270, given alone or with the immune drug adebelimab, can help prevent recurrence in adults who had radical treatment for high‑risk malignant solid tumors.

  Recruiting Phase 1 Fudan University · Shanghai · NCT07348042

• Evaluating XNW29016 Tablets for Advanced Solid Tumors After Standard Treatment Failure

  This study is testing if XNW29016 tablets can help people with advanced solid tumors who haven't responded to regular treatments.

  Recruiting Phase 1/2 Evopoint Biosciences Inc. · Beijing, Beijing Municipality · NCT06987500

• Evaluating AD1208 for advanced solid tumors

  This study is testing a new drug called AD1208 to see if it is safe and tolerable for people with advanced solid tumors.

  Recruiting at 3 sites Phase 1/2 Avelos Therapeutics Inc. · Seongnam-si, Gyeonggi-do and 2 other locations · NCT06911333

• Nutritional management for children with solid tumors

  This study is testing a new nutrition plan to see if it helps children with solid tumors get better nutrition and improve their health.

  Recruiting Children's Hospital of Fudan University · Shanghai, Shanghai Municipality · NCT06730204

• T-cell therapy for patients with advanced solid tumors

  This study is testing a new T-cell therapy for patients with advanced solid tumors, like pancreatic and lung cancer, who haven't had success with other treatments to see if it can help them.

  Recruiting at 2 sites Phase 1 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei and 1 other locations · NCT06484556

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.