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

Phase 1

• Conditions: Advanced Solid Tumors
• Interventions: Biological: An anticancer medication (A01) and immune cells (IC01)

• Registration Number: NCT03472352
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-03
• Study First Submitted: 2018-03-07
• Study First Submitted QC: 2018-03-20
• Last Update Submitted: 2018-03-20
• Study First Posted: 2018-03-21
• Last Update Posted: 2018-03-21
• Study Start: 2018-04
• Primary Completion: 2019-04
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	An anticancer medication (A01) and immune cells (IC01)	The subjects will be given an anticancer medication (A01) and immune cells (IC01).

Primary Outcome Measures

Name	Time	Method
The adverse events associated with infusion of the anticancer medication or the immune cells will be assessed.	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

Name	Time	Method
Tumor Response of the treatment in patients with advanced solid tumors.	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.