HIV InfectionsNCT05922384
Safety and Efficacy Study of KL-7SHRNA Injection Solution in the Treatment of AIDS Patients With Lymphoma
A study testing KL-7SHRNA injection solution in people with HIV Infections and Lymphoma, run by Affiliated Hospital of Guangdong Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV Infections, Lymphoma
- What is being tested?
- KL-7SHRNA injection solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- 5 Jul 2023to 10 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated hospital of Guangdong medical university
Zhanjiang, Guangdong, 524001
jinqi huang, PhD, +86-0759-2386971, Jinqi@gdmu.edu.cn
About this study
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.
Read the detailed description
Primary objectives:
- 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.
- 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.
- 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.
- Conditions
- HIV Infections, Lymphoma
- Being tested
- KL-7SHRNA injection solution
- Keywords
- HIV-1 infection; Lymphoma; gene therapy; 7shRNA
- Medical subject headings
- HIV Infections, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KL-7SHRNA injection solutionDrug
Also called Drug: carmustine Given IV Other Names: BCNU BiCNU bis-chloronitrosourea, Drug: etoposide Given IV Other Names: EPEG VP-16 VP-16-213, Drug: cytosine arabinoside Given IV, Drug: melphalan Given IV
Patients continue to receive HAART throughout treatment until meet the criteria of interruption of HAART.
| Study group | Role | What they receive |
|---|---|---|
| 7shRNA modified CD34+stem cells | Experimental | Patients undergo high-dose chemotherapy or chemoradiotherapy according to institutional guidelines and then received hematopoietic stem cell transplant on day 0 Receives: Drug: KL-7SHRNA injection solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Number of patients alive all over the trial
Measured: D0 post-infusion to completion of follow-up, an average of 2 year
Engraftment time of 7shRNA modified CD34+ stem cells
Haematological engraftment is defined as first day of neutrophil count >500/mm3 and platelets >20,000/mm3 on 7 consecutive blood counts.
Measured: within day +28 after gene therapy
Secondary outcomes (3)
7shRNA VCN
Detection of 7shRNA VCN in CD4+T cells via qPRC.
Measured: At week 2, months 1, 2, 3, 4, 5, 6, 7, 8, 9，10,12，15,18,21and 24 post-transplant
Duration of interruption of HAART
At two months post-transplant, or later, HAART will be voluntarily interrupted only for participants who have a CD4 count of 200 or higher with no detectable viral load and 7shRNA VCN>0.5, for participants in which the CD4 T-cell count has not risen to ≥ 200 cells/mm3 at the time of the planned HAART interruption, HAART will continue until the T-cell count has risen to ≥ 200 cells/mm3.
Measured: Up to 24 months post-treatment
Transplantation related mortality
Number of patients die of transplantation all over the trial
Measured: Up to 24 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start5 Jul 2023 (estimated)
- Primary completion10 Sep 2025 (estimated)
- Study completion10 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Guangdong Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinqi Huang, Affiliated Hospital of Guangdong Medical University
- Investigators
- yuming Zhang, PhD, Principal investigator, Affiliated hospital of Guangdong medical university, Guangdong province, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922384
- Sponsor's protocol ID
- KL210515
- Status last verified
- Jun 2023
- First submitted
- 16 Jun 2023
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of KL-7SHRNA Injection Solution in the Treatment of AIDS Patients With Lymphoma
- ClinicalTrials.gov ID
- NCT05922384
- Acronym / sponsor ID
- KL210515
- Conditions
- HIV Infections, Lymphoma
- Keywords
- HIV-1 infection; Lymphoma; gene therapy; 7shRNA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Guangdong Medical UniversityUniversity, hospital or other
- Study start
- 5 Jul 2023 (estimated)
- Primary completion
- 10 Sep 2025 (estimated)
- Study completion
- 10 Apr 2026 (estimated)
- First posted
- 28 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 7shRNA modified CD34+stem cells | Experimental | Drug: KL-7SHRNA injection solutionPatients undergo high-dose chemotherapy or chemoradiotherapy according to institutional guidelines and then received hematopoietic stem cell transplant on day 0 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KL-7SHRNA injection solutionAlso: Drug: carmustine Given IV Other Names: BCNU BiCNU bis-chloronitrosourea, Drug: etoposide Given IV Other Names: EPEG VP-16 VP-16-213, Drug: cytosine arabinoside Given IV, Drug: melphalan Given IVPatients continue to receive HAART throughout treatment until meet the criteria of interruption of HAART. | Drug | 7shRNA modified CD34+stem cells |
Primary outcome
Overall survival
Time frame: D0 post-infusion to completion of follow-up, an average of 2 year
Number of patients alive all over the trial
Engraftment time of 7shRNA modified CD34+ stem cells
Time frame: within day +28 after gene therapy
Haematological engraftment is defined as first day of neutrophil count >500/mm3 and platelets >20,000/mm3 on 7 consecutive blood counts.
3 secondary outcomes
7shRNA VCN
Time frame: At week 2, months 1, 2, 3, 4, 5, 6, 7, 8, 9，10,12，15,18,21and 24 post-transplant
Duration of interruption of HAART
Time frame: Up to 24 months post-treatment
Transplantation related mortality
Time frame: Up to 24 months post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yuming Zhang, PhD principal investigator
Affiliated hospital of Guangdong medical university, Guangdong province, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KL-7SHRNA injection solution in people with HIV Infections and Lymphoma, run by Affiliated Hospital of Guangdong Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jinqi huang, PhD (+86-0759-2386971, Jinqi@gdmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: D0 post-infusion to completion of follow-up, an average of 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.