TCR-engineered T Cells (NW-101C) in Patients With Solid Malignant Tumors

Summary

This clinical trial is a prospective, dose-escalation, multicenter, single- arm, Phase 1 clinical trial to evaluate the safety, tolerability, PK and preliminary clinical activity of PRAME Antigen-targeted TCR-T Cells (NW-101C) infusion in patients with previously heavily treated, metastatic solid malignant tumors.

Eligibility

Inclusion Criteria:

* Age between 18-75 years
* Diagnosis of pathologically or histologically confirmed unresectable or advanced solid tumors and must have no standard treatment options available or unable to tolerate the currently available standard treatments
* For patients with ovarian caner :Patients must have confirmed diagnosis of Platinum-resistant ovarian epithelial carcinoma(PROC)
* HLA-A\*02:01positive
* Patient's tumor must express PRAME assessed by central lab,Retrospective testing will be required for patients that qualify.
* 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)

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)

Conditions2

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