Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04076137
Other study ID # BK2019.01
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date May 1, 2019
Est. completion date May 1, 2021

Study information

Verified date August 2019
Source Benhealth Biopharmaceutical (Shenzhen) Co., Ltd.
Contact Zhengzheng Li, Doctor
Phone 0755-26912981
Email lizhengcheng07@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a single-center, open, single-arm controlled prospective clinical trial of patients with solid tumors treated with targeted activation of T cells through intravenous infusion.The purpose of this study was to evaluate the clinical efficacy and safety of targeted activated T cells in the treatment of solid tumors.


Description:

In China, malignant tumors have become the leading cause of death for urban and rural residents, with solid tumors accounting for 77 percent.Immunotherapy is considered one of the most promising ways to fight cancer.This study is a single-center, open, single-arm controlled clinical trial (after intravenous infusion of targeted T cells, compare the changes of self-lesion). The essence of this study is to collect immune cells to the surrounding of tumor cells, so that immune cells can kill tumor cells at close range.The researchers plan to enroll 10 patients with solid tumors and follow them up to the end of the study after completing 9 courses of treatment.The results of this study were statistically analyzed using RECIST1.1 records.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date May 1, 2021
Est. primary completion date May 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:1. Age: 18~75 years old; 2. Patients with solid tumors still show progress after radiotherapy, chemotherapy and targeted therapy, with at least one measurable lesion; 3. No congenital autoimmune diseases or immunodeficiency diseases;' 4. At least one or more solid tumor targets of HER2, MUC1, CEA, EGFR and GPC3 were positive by immunohistochemical examination of tumor tissues; 5. No serious infectious diseases (hepatitis b, c, syphilis, AIDS); 6. Sign informed consent voluntarily. -

Exclusion Criteria:1. The researchers determined that the patient could not complete 6 courses of treatment.

2. Patients with t-cell lymphoma. 3. Pregnant or lactating female patients, or those who do not want to use contraception during the trial.

4. Allergic to both CT and MRI contrast agents and unable to conduct imaging evaluation.

5. Other patients in the treated group who were considered as unfit for cell therapy.

-

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Targeted T-cell armed with bispecific antibody (Decitabine)
In this study, 10 patients eligible for the study were clinically screened for intravenous infusion of targeted activated T cells,every participant has a unique identification number and emergency letter which have the information of group.

Locations

Country Name City State
China Department of oncology, the second people's hospital of shenzhen Shenzhen Guangdong

Sponsors (2)

Lead Sponsor Collaborator
Benhealth Biopharmaceutical (Shenzhen) Co., Ltd. Shenzhen Second People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other TTP Time tumor progression.The time of patient from randomization to objective progress of the tumor. 1 year.
Other DCR Disease control rate.The proportion of patients who had a best response rating of complete response, partial response, or stable disease. 1 year.
Other ORR Objective response rate.The proportion of patients who had a best response rating of complete response and partial response. 1 year.
Other SRR Symptom remission rate. The proportion of symptoms are alleviated in all evaluative cases. 1 year.
Primary OS Overrall survival.The time of patient from randomization to death caused by any cause. 1 year .
Secondary PFS Progression-free survival.The time of patients from randomization to death caused by the progression of the tumor or any cause. 1 year.
See also
  Status Clinical Trial Phase
Terminated NCT01846429 - Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain Phase 1
Completed NCT01359982 - Safety and Pharmacokinetic Study of RRx-001 in Cancer Subjects Phase 1
Completed NCT01648764 - A Study of LY2334737 in Participants With Cancer That is Advanced and/or Has Spread Phase 1
Completed NCT00725634 - A Phase 1 Dose-Escalation Study in Advanced Solid Tumors, Lymphomas or Multiple Myeloma Phase 1
Recruiting NCT04083599 - GEN1042 Safety Trial and Anti-tumor Activity in Subjects With Malignant Solid Tumors Phase 1/Phase 2
Recruiting NCT05141474 - Assessment of the Safety and Tolerability of ex Vivo Next-generation Neoantigen-selected Tumor-infiltrating Lymphocyte (TIL) Therapy in Advanced Epithelial Tumors and Immune Checkpoint Blockade (ICB) Resistant Solid Tumors Early Phase 1
Active, not recruiting NCT02999750 - EXtendedAnalysis for Cancer Treatment N/A
Completed NCT01457118 - An Extension Study of NKTR-102 in Cancer Patients Previously Enrolled in NKTR-102 Studies Phase 2
Active, not recruiting NCT05539157 - Study to Evaluate JCXH-211 as Monotherapy in Patients With Malignant Solid Tumors Phase 1
Recruiting NCT04571892 - A Clinical Study to Observe the Safety and Efficacy of ScTIL210 in the Treatment of Malignant Solid Tumors Phase 1/Phase 2
Recruiting NCT05468359 - Safety and Efficacy of Cyclophosphamide, Sorafenib, Bevacizumab, and Atezolizumab in Pediatric Solid Tumor Patients Phase 1/Phase 2
Recruiting NCT04168528 - Phase I/IIa Study of 68GaNOTA-Anti-MMR-VHH2 for PET/CT Phase 1/Phase 2
Recruiting NCT04145622 - Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors Phase 1/Phase 2
Recruiting NCT06057038 - A Safety Trial of GEN1042 in Japanese Subjects With Malignant Solid Tumors Phase 1
Completed NCT02844400 - Cancer Patients' Performance Status Assessed Using Cardiopulmonary Exercise Testing and Wearable Data Generation
Completed NCT00452413 - A Study of Enzastaurin and Erlotinib in Participants With Solid Tumors and Lung Cancer Phase 1/Phase 2
Completed NCT03553108 - A Study Using Olaparib Tablets for Subjects With Advanced Solid Tumours. Phase 1
Recruiting NCT06391775 - Trial to Assess the Safety and Preliminary Efficacy of GEN1055 on Malignant Solid Tumors as Monotherapy and as Combination Therapy Phase 1/Phase 2
Terminated NCT03192345 - A First-in-human Study of the Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR439459 Monotherapy and Combination of SAR439459 and Cemiplimab in Patients With Advanced Solid Tumors Phase 1
Completed NCT02754141 - An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With Nivolumab Phase 1/Phase 2