ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy of an Anticancer Medication Combined With Immune Cells in Subjects With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03472352
Recruitment Status : Not yet recruiting
First Posted : March 21, 2018
Last Update Posted : March 21, 2018
Sponsor:
Collaborator:
The Second People's Hospital of Yibin
Information provided by (Responsible Party):
Hangzhou Converd Co., Ltd.

Brief Summary:
This is an open-label study to evaluate the safety and efficacy of an anticancer medication (A01) with immune cells (IC01) in subjects with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Biological: An anticancer medication (A01) and immune cells (IC01) Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Combination Study to Evaluate the Safety and Efficacy of an Anti-cancer Medication (A01) With Immune Cells (IC01) in Subjects With Advanced Solid Tumors
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Arm Intervention/treatment
Experimental: Single Arm
The subjects will be given an anticancer medication (A01) and immune cells (IC01).
Biological: An anticancer medication (A01) and immune cells (IC01)
The administration of A01 and IC01 will be performed in the Second People's Hospital of Yibin, Sichuan, China. The subjects will be observed for any side effects during this time and all the adverse events will be recorded.




Primary Outcome Measures :
  1. The adverse events associated with infusion of the anticancer medication or the immune cells will be assessed. [ Time Frame: Day 0 to 4 months after the end of the study ]
    Incidence and duration of all the adverse events will be recorded. The severity of adverse events will be evaluated according to NCI-CTCAE v4.03 criteria.


Secondary Outcome Measures :
  1. Tumor Response of the treatment in patients with advanced solid tumors. [ Time Frame: Before treatment and Day 28 to 4 months after the end of the treatment ]
    Response Evaluation Criteria in Solid Tumors (RECIST) from the NCI will be used for assessment of radiographic response.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Signed informed consent form must be obtained prior to any research procedures;
  2. Age: 18 Years to 70 Years;
  3. The patient's biological parent or child whose age ≥18 years voluntarily donates peripheral blood (100-200 ml) for the treatment, and who signs the informed consent form independently;
  4. Histologically confirmed diagnosis of solid tumors;
  5. Patients who have received at least one standard treatment (surgery, chemotherapy, radiotherapy, or targeted therapy) or refuse to receive standard treatments;
  6. KPS > 60 points;
  7. expected survival > 6 months;
  8. Adequate organ function defined as: ANC≥1.0×10^9/L, PLT≥50×10^9/L, ALB≥25g/L;
  9. If a subject is a female of childbearing potential, she must have a negative urine pregnancy test result.

Exclusion Criteria:

  1. Patients who received chemotherapy, large-field radiotherapy or participated in other studies of anti-tumor therapy within 2 weeks before enrollment;
  2. Patients who have not recovered from adverse reactions related to above-mentioned procedures;
  3. Patients with two types of primary solid tumors;
  4. Patients with brain metastases or bone metastases;
  5. Patients with poorly controlled hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 90 mmHg), or cardiovascular and cerebrovascular diseases with clinical significance, such as cerebrovascular accident (within 6 months before signing informed consent), myocardial infarction (within 6 months before signing informed consent), unstable angina, congestive heart failure (New York Heart Association ClassⅡ or above), or severe arrhythmia which can't be controlled with drugs or have potential impact on the treatment;
  6. Patients with other serious organic diseases or mental disorders;
  7. Patients with systemic or active infection;
  8. Patients with positive HIV test result;
  9. Patients who have received an organ transplant;
  10. Patients who are breastfeeding or pregnant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03472352


Contacts
Contact: Lin Chen, PhD +86 18005817715 chenlin@converd.com.cn

Sponsors and Collaborators
Hangzhou Converd Co., Ltd.
The Second People's Hospital of Yibin

Responsible Party: Hangzhou Converd Co., Ltd.
ClinicalTrials.gov Identifier: NCT03472352     History of Changes
Other Study ID Numbers: CVD20180401
First Posted: March 21, 2018    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No