Clinical trial · Interventional
Safety and Efficacy Study of KL-7SHRNA Injection Solution in the Treatment of AIDS Patients With Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HIV Infections | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KL-7SHRNA injection solution | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 7shRNA modified CD34+stem cells
- description
- Patients undergo high-dose chemotherapy or chemoradiotherapy according to institutional guidelines and then received hematopoietic stem cell transplant on day 0
- interventionNames
- Drug: KL-7SHRNA injection solution
Primary outcomes (2)
- measure
- Overall survival
- timeFrame
- D0 post-infusion to completion of follow-up, an average of 2 year
- description
- Number of patients alive all over the trial
- measure
- Engraftment time of 7shRNA modified CD34+ stem cells
- timeFrame
- within day +28 after gene therapy
- description
- Haematological engraftment is defined as first day of neutrophil count \>500/mm3 and platelets \>20,000/mm3 on 7 consecutive blood counts.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available