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Trial Title:
Safety and Efficacy Study of KL-7SHRNA Injection Solution in the Treatment of AIDS Patients With Lymphoma
NCT ID:
NCT05922384
Condition:
HIV Infections
Lymphoma
Conditions: Official terms:
Lymphoma
Etoposide
Melphalan
Carmustine
Conditions: Keywords:
HIV-1 infection; Lymphoma; gene therapy; 7shRNA
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
KL-7SHRNA injection solution
Description:
Patients continue to receive HAART throughout treatment until meet the criteria of
interruption of HAART.
Arm group label:
7shRNA modified CD34+stem cells
Other name:
Drug: carmustine Given IV Other Names: BCNU BiCNU bis-chloronitrosourea
Other name:
Drug: etoposide Given IV Other Names: EPEG VP-16 VP-16-213
Other name:
Drug: cytosine arabinoside Given IV
Other name:
Drug: melphalan Given IV
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.
Detailed description:
Primary objectives:
1. To determine the safety and feasibility of using lenti-7shRNA transduced
hematopoietic stem/progenitor cells in the setting of autologous hematopoietic cell
transplantation for treatment of HIV infection combined with lymphoma. The safety of
the genetically modified product used in the transplant procedure will be assessed
by monitoring each subject for adverse events (procedure related toxicity); absolute
neutrophil count (ANC)/platelet engraftment (sustained recovery); and evidence of
replication competent vector or vector recombination with the human immunodeficiency
virus (HIV) quasi-species present in the patient.
2. To determine the quantity and duration of vector-marked peripheral blood cells and
to characterize: the duration and level of gene marking and expression of the
anti-HIV shRNA in these transduced cells, and the characterization of the
integration sites of vector sequences in circulating cells if there is a clinical
syndrome suggestive of a clonal expansion of hematopoietic cells. In addition, the
feasibility of the process will be assessed based on the results of the release
testing of the transduced cells prior to injection into the patient.
3. To measure the effect of HIV infection on the presence of HIV-resistant blood cells
as measured by genetic marking for vector sequences before and after antiviral
treatment interruption.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
60 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Affiliated hospital of Guangdong medical university
Address:
City:
Zhanjiang
Zip:
524001
Country:
China
Status:
Recruiting
Contact:
Last name:
jinqi huang, PhD
Phone:
+86-0759-2386971
Email:
Jinqi@gdmu.edu.cn
Start date:
July 5, 2023
Completion date:
April 10, 2026
Lead sponsor:
Agency:
Affiliated Hospital of Guangdong Medical University
Agency class:
Other
Source:
Affiliated Hospital of Guangdong Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05922384
