A Phase 1 interventional study of Fludarabine and Cyclophosphamide in Advanced Solid Cancer, Pancreatic Ductal Adenocarcinoma (PDAC) and Colorectal Adenocarcinoma, sponsored by Neowise Biotechnology. Not yet recruiting at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Neowise Biotechnology · Phase 1, Interventional, and Treatment
This is a single-arm, multicenter, open-label, Phase 1a/1b dose-escalation and dose-expansion study designed to evaluate the safety, preliminary antitumor activity, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of NW-301V, an autologous TCR-T cell therapy, in Chinese adult participants with advanced malignant solid tumors harboring a KRAS G12V mutation.
There are 2 parts in this study：
Participants who meet the protocol-defined eligibility criteria during screening will undergo leukapheresis for the manufacture of NW-301V. Prior to NW-301V infusion, participants will receive a lymphodepletion (LD) regimen consisting of fludarabine and cyclophosphamide. Participants will be closely monitored for safety, tolerability and treatment response throughout the study.
315 studies on the registry are indexed under Adenocarcinoma of Lung; 83 are open to participants now.
This study's planned enrollment of 66 is close to the median of 62 across 220 interventional studies indexed under Adenocarcinoma of Lung.
Browse Adenocarcinoma of Lung studies →Neowise Biotechnology is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Applicable to both Phase 1a and 1b:
For Phase 1a only:
For Phase 1b only:
(Additional protocol-defined Inclusion criteria may apply)
Key Exclusion Criteria:
Applicable to both Phase 1a and 1b:
(Additional protocol-defined Inclusion criteria may apply)
Participants receive lymphodepletion and a single infusion of NW-301V, an autologous TCR-T cell therapy targeting KRAS G12V. In Phase 1a (dose escalation), two dose levels at 4×10\^9 (±30%) and 8×10\^9 (±30%) TCR-T+ cells will be tested. In Phase 1b (dose expansion), NW-301V will be administered at provisional RP2D in 3 tumor-specific cohorts (Cohort A: pancreatic ductal adenocarcinoma; Cohort B: colorectal adenocarcinoma; Cohort C: lung adenocarcinoma), each containing around 20 participants.
Drug: Fludarabine · Drug: Cyclophosphamide · Biological: NW-301V
Used for lymphodepletion
Used for lymphodepletion
NW-301V is an autologous TCR-T cell therapy targeting KRAS G12V in the context of HLA-A\*11:01, administered intravenously after lymphodepletion.
Phase 1a: Safety and tolerability of NW-301V in participants with advanced solid tumors
Type, frequency, and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), abnormalities in vital signs, electrocardiograms (ECGs) and other laboratory results.
Time frame: Through the study completion, an average of 2 years
Phase 1a: Maximum tolerated dose (MTD, if applicable) and provisional Recommended Phase 2 Dose (RP2D)
Number of participants with dose-limiting toxicities (DLTs) and their types.
Time frame: 28 days
Phase 1b: Safety and tolerability of NW-301V in PDAC, CRC and LUAD respectively under provisional RP2D
Type, frequency, and severity of TEAEs, SAEs, and abnormalities in vital signs, ECGs and other laboratory results.
Time frame: Through the study completion, an average of 2 years
Phase 1b: Final RP2D of NW-301V
Determine the final RP2D of NW-301V
Time frame: Up to 2 years
Objective response rate (ORR)
Assessed by RECIST v1.1. (Phase 1a: in the entire cohort; Phase 1b: in PDAC, CRC and LUAD respectively)
Time frame: Through the study completion, an average of 2 years
Disease control rate (DCR)
Assessed by RECIST v1.1. (Phase 1a: in the entire cohort; Phase 1b: in PDAC, CRC and LUAD respectively)
Time frame: Through the study completion, an average of 2 years
Duration of response (DOR)
Assessed by RECIST v1.1. (Phase 1a: in the entire cohort; Phase 1b: in PDAC, CRC and LUAD respectively)
Time frame: Through the study completion, an average of 2 years
Progression-free survival (PFS)
Assessed by RECIST v1.1. (Phase 1a: in the entire cohort; Phase 1b: in PDAC, CRC and LUAD respectively)
Time frame: Through the study completion, an average of 2 years
Overall survival (OS)
(Phase 1a: in the entire cohort; Phase 1b: in PDAC, CRC and LUAD respectively)
Time frame: Through the study completion, an average of 2 years
Maximum blood concentration (Cmax) of NW-301V
Time frame: Through the study completion, an average of 2 years
Time to maximum concentration (Tmax) of NW-301V
Time frame: Through the study completion, an average of 2 years
Persistence of NW-301V TCR-T cells in vivo
Determined by qPCR-measured gene copies
Time frame: Through the study completion, an average of 2 years
Start is estimated for Oct 2026; primary completion for Mar 2030, 41 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: NW-301V
Neowise Biotechnology