Phase 1
N=12
PD-1 Knockout Engineered T Cells for Metastatic Non-small Cell Lung Cancer
Metastatic Non-small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02793856 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Number of Participants With Adverse Events and/or Dose Limiting Toxicities as a Measure of Safety and Tolerability of Dose of PD-1 Knockout T Cells Using Common Terminology Criteria for Adverse Events (CTCAE v4.0) in Patients — 2; 4; 3; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Cyclophosphamide (Drug); PD-1 Knockout T Cells (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sichuan University
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events and/or Dose Limiting Toxicities as a Measure of Safety and Tolerability of Dose of PD-1 Knockout T Cells Using Common Terminology Criteria for Adverse Events (CTCAE v4.0) in Patients |
2; 4; 3; 2 | — |
| SECONDARY Number of Patients With Overall Response |
0; 0; 0; 0 | — |
| SECONDARY Number of Patients With Disease Control at 8 Weeks |
1; 0; 1; 0 | — |
| SECONDARY Progression Free Survival (PFS) |
11.7; 8.0; 8.1; 6.1 | — |
| SECONDARY Overall Survival (OS) |
47.5; 51.4; 32.6; 51.6 | — |
| SECONDARY Number of Participants With Genes Mutations in Peripheral Blood Circulating Tumor DNA (ctDNA) |
0; 1; 1; 1 | — |
| SECONDARY Interleukin-6 Change in the Peripheral Blood. |
10.68; 3.27; 51.97; 10.59; 12.9; 4.37 | — |
| SECONDARY Interleukin-10 Change in the Peripheral Blood. |
5.00; 5.00; 5.00; 5.00; 5.00; 5.00 | — |
| SECONDARY Tumor Necrosis Factor-a Change in the Peripheral Blood. |
13.84; 6.07; 8.89; 5.06; 10.68; 7.84 | — |
Summary
This study will evaluate the safety of PD-1 knockout engineered T cells in treating metastatic non-small cell lung cancer. Blood samples will also be collected for research purposes.
Eligibility Criteria
Inclusion Criteria
- Pathologically verified stage IV non-small cell lung cancer with measurable lesions (On CT: longest diameter of tumoral lesion >=10 mm, shorted diameter of lymph node >=15 mm; measurable lesions should not have been irradiated)
- Progressed after all standard treatment
- Performance score: 0-1
- Expected life span: >= 6 months
- Toxicities from prior treatment has resolved. Washout period is 4 weeks for chemotherapy, and 2 weeks for targeted therapy
- Major organs function normally
- Women at pregnant ages should be under contraception
- Willing and able to provide informed consent
Exclusion Criteria
- Pathology is mixed type
- Emergent treatment of tumor emergency is needed
- Poor vasculature
- Coagulopathy, or ongoing thrombolytics and/or anticoagulation
- Blood-borne infectious disease, e.g. hepatitis B
- History of mandatory custody because of psychosis or other psychological disease inappropriate for treatment deemed by treating physician
- With other immune diseases, or chronic use of immunosuppressants or steroids
- Compliance cannot be expected
- Other conditions requiring exclusion deemed by physician
Data sourced from ClinicalTrials.gov (NCT02793856). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.