A Clinical Research of CAR T Cells Targeting HER2 Positive Cancer

Breast Cancer Clinical Trial

Official title:

A Clinical Research of CAR T Cells Targeting HER2 Positive Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02713984
• Other study ID #: TMMU-BTC-005
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: March 2016
• Est. completion date: July 2019

Study information

• Verified date: March 2020
• Source: Southwest Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chimeric antigen receptor T cells (CAR-T) therapy has not yet been fully explored in solid tumors. Human epidermal growth factor receptor-2(HER2) is widely expressed in cancers. Investigators have developed anti-HER2 CAR-modified T cells and validated the efficiency targeting HER2-positive cancer in preclinical studies. This study is aimed to confirm its adverse effects including cytokine storm response and any other adverse effects. In addition, CAR-T cells persistence, tumor elimination and disease status after treatment will be evaluated.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Relapsed or refractory HER2 positive cancer.

2. KPS>60.

3. Life expectancy>3 months.

4. Gender unlimited, age from 18 years to 80 years.

5. Assessable lesions with a minimum size of 10mm by CT scan or MRI.

6. Acceptable organ function

Hematology:

• Absolute neutrophil count greater than 800/mm^3 without the support of filgrastim.

• White blood cell (WBC) (> 2000/mm^3).

• Platelet count greater than 50,000/mm^3.

• Hemoglobin greater than 9.0 g/dl.

Chemistry:

• Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less or equal to 3 times the upper limit of normal (patients without liver metastasis) or 6 times the upper limit of normal (patients with liver metastasis).

• Serum creatinine less or equal to 3 times the upper limit of normal

• Total bilirubin less than or equal to 3 times the upper limit of normal.

7. No other serious diseases(autoimmune disease, immunodeficiency etc.).

8. Adequate cardiac function(LVEF=40%).

9. No other tumors.

10. Patients volunteer to participate in the research.

Exclusion Criteria:

1. Allergic to cytokines.

2. Uncontrolled active infection.

3. Acute or chronic GVHD.

4. MODS.

5. Treated with T cell inhibitor.

6. HIV affected.

7. Other situations improper for the research.

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Gastric Cancer
• Glioma
• Lung Cancer
• Ovarian Cancer
• Pancreatic Cancer

Intervention

Biological:
• Anti-HER2 CAR-T
HER-2-targeting CAR-T cells infusion in HER2 positive cancers

Locations

Country	Name	City	State
China	Southwest Hospital of Third Millitary Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Zhi Yang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the toxicity profile of the HER2 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.	Observe and handle the toxicity profile of the HER2 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.	3 years
Secondary	Survival time of Anti-HER2 CAR T cells in vivo.	Detect the existence of CAR-T cells in the blood of participants through qPCR or flow cytometry.	1 year
Secondary	Efficacy of anti-HER2 CAR T cells to confirm the ability of CAR T cells to eliminate HER2 positive cancer cells	Evaluate the anti-tumor efficacy of CAR-T therapy by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 and Immune-Related Response Criteria(iRECIST).	12 weeks
Secondary	Maximum tolerated dose (MTD) of HER2 targeted CAR T cells	Determine the maximum tolerated dose of each participant through the grades of side effects.	4 weeks