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PD-1 Knockout Engineered T Cells for Advanced Breast Cancer

A Phase II Trial of PD-1 Knockout Engineered T Cells for the Treatment of Advanced Breast Cancer progressed after multi-line treatment

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-17010370
Enrollment
Unknown
Registered
2017-01-09
Start date
2017-01-21
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced breast cancer

Interventions

experimental group:PD-1 Knockout Engineered T Cells

Sponsors

Anhui Province Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Stage III/B or IV breast cancer; 2. Measurable disease; 3. Progressed after all standard treatmen; 4. ECOG performance status of 0-2; 5. Expected life span: >= 3 months; 6. Toxicities from prior treatment has resolved. Washout period is 4 weeks for chemotherapy, and 2 weeks for targeted therapy; 7. Major organs function normally; 8. Women at pregnant ages should be under contraception; 9. Hematologic studies satisfy the following requirements within 1 week before treatment: 1) WBC=3×10^9/L; ANC=1.5×10^9/L; Hb=80g/L; PLT=80×10^9/L; 2) TBIL=1.5×ULN (upper limit of normal), ALT and AST=2×ULN (Ifany liver metastasis); 3) the endogenous creatinine clearance=60 ml/min (according to the calculated formula Gault Cockcroft); 10. Willing and able to provide informed consent.

Exclusion criteria

Exclusion criteria: 1. Pathology is not adenocarcinoma; 2. Emergent treatment of tumor emergency is needed; 3. Poor vasculature; 4. Coagulopathy, or ongoing thrombolytics and/or anticoagulation; 5. Blood-borne infectious disease, e.g. hepatitis B; 6. History of mandatory custody because of psychosis or other psychological disease inappropriate for treatment deemed by treating physician; 7. With other immune diseases, or chronic use of immunosuppressants or steroids; 8. Compliance cannot be expected; 9. Other conditions requiring exclusion deemed by physician.

Design outcomes

Primary

MeasureTime frame
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;Response Rate;Progression free survival (PFS);Overall Survival (OS);—

Secondary

MeasureTime frame
Peripheral blood circulating tumor DNA;Temporal Interleukin-2 change in the peripheral blood;Temporal Interferon-? change in the peripheral blood;—

Countries

China

Contacts

Public ContactYueyin Pan

Anhui Province Hospital

yueyinpan1965@163.com+86 13805695536

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026