Clinical Study of Plasmodium Immunotherapy for Advanced Breast Cancers and Advanced Liver Cancers

Who is this study for? Patients with Breast Cancer, Liver Cancer
What treatments are being studied? Blood-Stage Infection of P.vivax
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

The purpose of this study is to evaluate the safety and preliminarily evaluate the effectiveness of Plasmodium immunotherapy for advanced breast cancers and advanced liver cancers.The treatment will last 4-6 weeks from the day of successful infection and will be terminated by antimalarial drugs.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 18-70 years of age, male or female.

• Patients with advanced breast cancer and advanced liver cancer confirmed by histopathology and imaging; and imaging lesions of the tumor are clear and measurable.

• Previously received at least one standard therapy.

• The time interval of the termination of chemotherapy (including interventional chemotherapy) or radiotherapy is at least 1 months for patients who had received chemotherapy or radiotherapy; at least 5 half-life for patients who had received targeted drug therapy (the half-life of targeted drug is according to the drug instructions).

• ECGO score of 0 or 1;

• Expected survival ≥ 6 months;

• PLT ≥100× 10\^9/L, NE ≥ 1.5 × 10\^9/L, and HGB ≥ 100 g/L; no significant morphological abnormalities of red blood cells, or anemia (iron deficiency anemia, autoimmune hemolytic anemia, thalassemia, etc.).

• The peripheral blood count of immune cells is close to normal or normal, the immune function test result is close to or at the level of normal population, and the function of heart, lung, liver and kidney are basically normal (the liver function classification of Child-push is A or B, Cr≤1.5×ULN);

• Patient compliance meets the need for follow-up;

• The subjects are able to understand and sign informed consent.

Locations
Other Locations
China
Plasmodiun vivax
RECRUITING
Guangzhou
Contact Information
Primary
Qin Li, M.D
njlf@cas-lamvac.com
0086-20-82258805
Backup
Zhang Su Yi, M.D
zhang_suyi@cas-lamvac.com
0086-20-82258805
Time Frame
Start Date: 2018-08-10
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 60
Treatments
Experimental: Blood-stage infection of P.vivax
This is a single arm study that plans to enroll 30 patients in each type cancer and each patient will be vaccinated with P.vivax-infected red blood cells containing approximately 0.1-1.0 × 10\^7 Plasmodium parasites. The treatment will last 4-6 weeks from the day of successful infection and will be terminated by antimalarial drugs.
Related Therapeutic Areas
Sponsors
Leads: CAS Lamvac Biotech Co., Ltd.

This content was sourced from clinicaltrials.gov