Safety and Efficacy Study of KL-7SHRNA Injection Solution in the Treatment of AIDS Patients With Lymphoma

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This pilot clinical trial studies gene therapy in treating patients with HIV-1 infecetion combined with lymphoma undergoing 7shRNA lentiviral vector transduced CD34+ hematopoietic stem cell transplant. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, CD34+hematopoietic stem cells are mobilized and collected from the patient's peripheral blood. The CD34+stem cells are then isolated and transduced with lenti-7shRNA vector and reinfused to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• Body mass index (BMI) 18-25, body weight should be ≥ 40kg;

• Meet the Diagnostic Criteria for AIDS and HIV Infection (WS293-2019), and be diagnosed as HIV seropositive;

• HIV infection combined with lymphoma, in partial remission or relapsed after initial complete remission, failed induction therapy, but responds to salvage therapy;

• Age-adjusted IPI 2-3 points;

• Meet the indications for autologous bone marrow transplantation after clinical evaluation;

• HIV viral load \<1000 copies/ml;

• Must have the ability to understand and the willingness to sign a written informed consent.

Locations
Other Locations
China
Affiliated hospital of Guangdong medical university
RECRUITING
Zhanjiang
Contact Information
Primary
jinqi huang, PhD
Jinqi@gdmu.edu.cn
+86-0759-2386971
Time Frame
Start Date: 2023-07-05
Estimated Completion Date: 2026-04-10
Participants
Target number of participants: 3
Treatments
Experimental: 7shRNA modified CD34+stem cells
Patients undergo high-dose chemotherapy or chemoradiotherapy according to institutional guidelines and then received hematopoietic stem cell transplant on day 0
Related Therapeutic Areas
Sponsors
Leads: Affiliated Hospital of Guangdong Medical University

This content was sourced from clinicaltrials.gov

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