CClinicalTrials.gg
Status unknownNCT01935843CART-HER-2Updated Jan 28, 2016

Treatment of Chemotherapy Refractory Human Epidermalgrowth Factor Receptor-2( HER-2) Positive Advanced Solid Tumors

A Phase 1/2 interventional study of CART-HER-2 in Advanced HER-2 Positive Solid Tumors, Chemotherapy Refactory and HER-2 Antibody Inhibitor Therapy Refactory, sponsored by Chinese PLA General Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-01-28.

Sponsored by Chinese PLA General Hospital · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

RATINALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous T cells may make the body build immune response to kill cancer cells.

PURPOSE: This clinical trial is to study genetically engineered lymphocyte therapy in treating patients with HER-2 positive advanced solid tumors,such as breast cancer, gastric cancer, hepatic carcinoma, endometrial cancer and ovary cancer.

Read the detailed description

PRIMARY OBJECTIVES:

I.Determine the safety and feasibility of the chimeric antigen receptor T cells transduced with anti-HER-2 vector(referred to as CART-HER-2 cells).

II.Determine duration of in vivo survival of CART-HER-2 cells. RT-PCR(reverse transcription polymerase chain reaction)analysis of whole blood will be used to detect and quantify survival of CART-HER-2 TCR zeta:CD137 and TCR(T-cell receptor) zeta cells over time.

SECONDARY OBJECTIVES:

I.For patients with detectable diseases, measure anti-tumor response due to CART-HER-2 cell infusions.

II.Estimate relative trafficking of CART-HER-2 cells in tumor bed.

III.Determine if cellular or humoral host immunity develops against the murine anti-HER-2, and assess correlation with loss of detectable CART-HER-2(loss of engraftment).

IV.Determine the relative subsets of CART-HER-2 T cells (Tcm,Tem,and Treg).

OUTLINE: Patients are assigned to 1 group according to order of enrollment. Patients receive anti-HER-2-CAR (coupled with CD137 and CD3 zeta signalling domains)vector-transduced autologous T cells on days 0,1, and 2 in the absence of unacceptable toxicity.

After completion of study treatment, patients are followed intensively for 6 months, every 3 months for 2 years, and annually thereafter for 13 years.

Estimate relative trafficking of CART-HER-2 cells in peripheral blood.

02

Conditions studied

  • Advanced HER-2 Positive Solid Tumors
  • Chemotherapy Refactory
  • HER-2 Antibody Inhibitor Therapy Refactory

Browse trials for

Keywords

  • CART-HER-2
  • HER-2 positive
  • Advanced
  • Refactory
  • Solid tumors
03

In context

Neoplasms

9,359 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.

This study's planned enrollment of 10 is below the median of 50 across 7,250 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Chemotherapy refractory HER-2-positive breast cancer, gastric cancer, non-small cell lung cancer, and chemotherapy resistant or relapsed ovary cancer.
  • Relapsed patients after anti-HER-2 using antibody or kinase inhibitor therapy.
  • Patients must be 18 years of age or older.
  • Patients must have an ECOG (Eastern Cooperative Oncology Group )performance status of 0-2.
  • Patients must have evidence of adequate bone marrow reserve, hepatic and renal function as evidenced by the following laboratory parameters:

Absolute neutrophil count greater than 1500/mm3. Platelet count greater than 100,000/mm3. Hemoglobin greater than 10g/dl (patients may receive transfusions to meet this parameter).

Total bilirubin \< 1.5 times upper limits of normal. Serum creatinine less than or equal to 1.6 mg/ml or the creatinine clearance must be greater than 70 ml/min/1.73m(2).

  • Seronegative for HIV antibody.
  • Seronegative for active hepatitis B, and seronegative for hepatitis C antibody.
  • Patients must be willing to practice birth control during and for four months following treatment.NOTE:women of child-bearing age must have evidence of negative pregnancy test.
  • Patients must be willing to sign an informed consent.

Exclusion criteria

Exclusion Criteria:

  • Patients with life expectancy less than 12 months will be excluded.
  • Patients with uncontrolled hypertension (> 160/95), unstable coronary disease evidenced by uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> New York Heart Association Class II), or myocardial infarction within 6 months of study will be excluded.
  • Patients with any of the following pulmonary function abnormalities will be excluded: FEV(forced expiratory volume), \< 30% predicted; DLCO (diffusing capacity of lung for carbon monoxide) \< 30% predicted (post-bronchodilator); Oxygen Saturation less than 90% on room air.
  • Patients with severe liver and kidney dysfunction or consciousness disorders will be excluded.
  • Pregnant and/or lactating women will be excluded.
  • Patients with active infections, including HIV, will be excluded, due to unknown effects of the vaccine on lymphoid precursors.
  • Patients with any type of primary immunodeficiencies will be excluded from the study.
  • Patients requiring corticosteroids (other than inhaled) will be excluded.
  • Patients with history of T cell tumors will be excluded.
  • Patients who are participating or participated any other clinical trials in latest 30 days will be excluded.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Anti-tumor responses of CART-HER-2

    Biological: CART-HER-2

Interventions

  • BiologicalCART-HER-2
06

What researchers measure

Primary outcomes

  1. Occurrence of Study related adverse events

    Time frame: Until week 24

Secondary outcomes

  1. Anti-leukemia response to CART-HER-2 cell infusions

    Time frame: up to 24 weeks

Other outcomes

  1. In vivo existence of CART-HER-2

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Chinese PLA General Hospital
    Beijing, Beijing 100853, China
    • Weidong Han, Dr. · Contact · hanwdrsw@sina.com · +86-10-13811421950
    • Yao Wang, Dr. · Principal investigator
    Recruiting
08

References and documents

Publications

  • Feng K, Liu Y, Guo Y, Qiu J, Wu Z, Dai H, Yang Q, Wang Y, Han W. Phase I study of chimeric antigen receptor modified T cells in treating HER2-positive advanced biliary tract cancers and pancreatic cancers. Protein Cell. 2018 Oct;9(10):838-847. doi: 10.1007/s13238-017-0440-4. Epub 2017 Jul 14. PubMed 28710747 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01935843
Lead sponsor
Chinese PLA General Hospital
Responsible party
Han weidong (Professor and Director, Chinese PLA General Hospital) — Principal investigator
First posted
Sep 5, 2013
Start date
Sep 2013
Primary completion
Sep 2016 (estimated)
Completion
Sep 2017 (estimated)
Last update
Jan 28, 2016

Study contacts

Weidong Han, Dr.
Contact
hanwdrsw@sina.com
+86-10-13651392893
Xiru Li, Dr.
Contact
Huyi0401@yahoo.com.cn
+86-10-13910594988
Weidong Han, Dr.
study chair · Chinese PLA General Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion