Clinical Study of Granulocyte Infusion for Advanced Cancer
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|ClinicalTrials.gov Identifier: NCT04124666|
Recruitment Status : Not yet recruiting
First Posted : October 11, 2019
Last Update Posted : October 11, 2019
Background & Rationale:
For years, most tumor immunotherapy researches have focused on T cell and natural killer (NK) cell therapies, most of which involve amplification and modification of the patient's immune cells for reinfusion therapy. However, for the treatment of solid tumors, there is currently little breakthrough. Recently, researchers have reported a colony of cancer-resistant mice developed from a single mouse that was immune to multiple lethal cancer cell injections. Further research revealed that such anti-cancer immunity can cause rapid shrinkage or disappearance of the tumors in other cancer-bearing mice. Interestingly, this therapeutic effect is due to the donor granulocytes, instead of T cells or NK cells. Infusion of granulocytes is a classic therapy in treating infection associated with granulocytopenia. Currently, clinical collection of blood components, including isolation of granulocytes, is a mature technique. The infusion of granulocytes is a viable anticancer therapy combining the classic technique and novel anticancer approach. This proposed trial will test whether granulocyte infusions from healthy unrelated donors can be used to treat advanced cancer. In the proposed trial, up to 100 Subjects with advanced cancer can be entered. Each patient will be given a dose of (2.0-5.0)x10^10 granulocytes from a different healthy donor every week over a course of 5 doses. The trial will evaluate the subject's cancer 7, 30, 90 and 180 days after the last infusion.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancer||Biological: Granulocytes||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study of Allogeneic Granulocyte Infusion in the Treatment of Patients With Advanced Cancer|
|Estimated Study Start Date :||October 1, 2019|
|Estimated Primary Completion Date :||September 30, 2022|
|Estimated Study Completion Date :||September 30, 2022|
Experimental: Granulocytes infusion only
Fresh, non-irradiated granulocytes from ABO, Rh, CMV compatible, unrelated donors; bioactivity of anti-cancer ability meets the criteria.
Granulocytes cross-matched for ABO-Rh and CMV; bioactivity of anti-cancer ability meets the criteria.
- Progression free survival (PFS) [ Time Frame: 90 days post treatment ]The trial will observe the subject's progression free survival for 3 months after the granulocyte infusions are completed.
- median Overall Survival (mOS) [ Time Frame: 180 days post treatment ]The patients will be followed 1 week, 1 month, 3 months and 6 months after the last treatment. Median Overall Survival will be measured as the length of time from the date of inclusion that half of the patients are still alive.
- Objective Response Rate (ORR ) [ Time Frame: 180 days post treatment ]Objective Response Rate will be evaluated based on the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. If a response is achieved in a patient, the evaluation will be repeated 4-6 weeks after the first evaluation to confirm the response.
- Disease Control Rate (DCR) [ Time Frame: 180 days post treatment ]Disease Control Rate will be measured as the percentage of patients achieved complete response (CR), partial response (PR) and stable disease (SD) to the treatment (evaluated based on RECIST 1.1).
- Quality of life measured in ECOG [ Time Frame: 180 days post treatment ]ECOG Scale of Performance Status will be evaluated for patients after treatment to reflect impact on quality of life.
- Treatment-related adverse events [ Time Frame: 5 weeks of treatment and 1 month post treatment ]Incidence of treatment-related adverse events as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
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): NCT04124666
|Contact: Wenjun Le, Ph.D||(+86)-email@example.com|
|Contact: Zhongming Liu, MD/Ph.D||(+86)-firstname.lastname@example.org|
|Principal Investigator:||Zhongming Liu, MD/Ph.D||Shanghai East Hospital, Shanghai Tongji University|