TCR-engineered T Cells (NW-101C) in Patients With Solid Malignant Tumors
ConditionSolid Metastatic Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNeowise Biotechnology
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
NW-101C
Biological/Vaccine4 dosage of NW-101C will be tested in this study using classic 3+3 dose escalation approach: 4×10\^8±30%, 8×10\^8±30%,15×10\^8±30% and 30×10\^8±30% TCR-T+ cells
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: NW-101C dose 1-4Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evaluate the Dose-limiting toxicities(DLTs) of NW-101C in patients with solid malignant tumors
Type, frequency and severity of adverse events assessed by CTCAE5.0
Time frame
28 days following NW-101C infusion2
Evaluate the Maximum Tolerated Dose (MTD) of NW-101C in patients with solid malignant tumors
Type, frequency and severity of adverse events assessed by CTCAE5.0
Time frame
Through the study completion, an average of 2 yearsSecondary outcomes
1
Evaluate the AUC of NW-101C in patients with solid malignant tumors
Area under the Plasma concentration versus time curve(AUC) assessed centrally
Time frame
2 years following NW-101C infusion2
Evaluate the Objective response rate (ORR) of NW-101C in patients with solid malignant tumors
Complete response (CR) and partial response (PR) assessed by investigators following RECIST1.1 criteria
Time frame
2 years following NW-101C infusion3
Evaluate the Cmax of NW-101C in patients with solid malignant tumors
Maximum Concentration(Cmax) assessed centrally
Time frame
Through the study completion, an average of 2 years4
Evaluate the Tmax of NW-101C in patients with solid malignant tumors
Time of Maximum Concentration assessed centrally
Time frame
Through the study completion, an average of 2 yearsSponsors and contacts
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Source ClinicalTrials.gov