Gene therapy for AIDS patients with lymphoma
Safety and Efficacy Study of KL-7SHRNA Injection Solution in the Treatment of AIDS Patients With Lymphoma
This study is testing a new gene therapy for people with HIV and lymphoma to see if it can safely help restore their blood cells after chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Affiliated Hospital of Guangdong Medical University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Zhanjiang, Guangdong) |
| Trial ID | NCT05922384 on ClinicalTrials.gov |
What this trial studies
This pilot clinical trial investigates the safety and efficacy of a gene therapy approach using KL-7SHRNA injection solution for patients suffering from HIV-1 infection and lymphoma. The study involves administering chemotherapy to halt cancer cell growth, followed by the collection and genetic modification of CD34+ hematopoietic stem cells using a lentiviral vector. These modified stem cells are then reinfused into the patient to restore blood-forming cells that were damaged by chemotherapy. The trial aims to assess the safety of this treatment and the persistence of genetically modified cells in the patient's bloodstream.
Who should consider this trial
Good fit: Ideal candidates include HIV-positive individuals with lymphoma who are in partial remission or have relapsed after initial treatment.
Not a fit: Patients with uncontrolled opportunistic infections or severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients with HIV and lymphoma, potentially improving their outcomes.
How similar studies have performed: While gene therapy approaches have shown promise in other contexts, this specific combination of HIV and lymphoma treatment is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Any HIV-related uncontrolled opportunistic infection, including fungal infection, sepsis, active tuberculosis, weightlessness, severe diarrhea, active opportunistic infections in the central nervous system or active hepatitis B, hepatitis C, and other viral infections such as CMV; * Cardiac insufficiency (LVEF\<50%), renal insufficiency (creatinine\>2mg/dl), hepatic insufficiency (AST/ALT\>3 ULN and/or PT \<70% unrelated to lymphoma); * HAART treatment failure (including at least one NRTI, one NNRTI and two PI) and/or CD4 count \< 50/cmm); * Malignancy other than lymphoma, unless (1) in complete remission and more than 5 years from last treatment, or (2) cervical/anal squamous cell carcinoma in situ or (3) superficial basal cell and squamous cell cancers of the skin; * Participation of other investigational agents (traditional Chinese medicine is not included) within 3 months； * Any concurrent or past medical condition that, in the opinion of the Investigator, would exclude the subject from participation or any psychosocial conditions that would hinder study compliance or follow-up, at the discretion of the Investigator.
Where this trial is running
Zhanjiang, Guangdong
- Affiliated hospital of Guangdong medical university — Zhanjiang, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: yuming Zhang, PhD — Affiliated hospital of Guangdong medical university, Guangdong province, China
- Study coordinator: jinqi huang, PhD
- Email: Jinqi@gdmu.edu.cn
- Phone: +86-0759-2386971
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.