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

NCT05922384 | Recruiting

• 1 other identifier: KL210515
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infections; Lymphoma

Keywords

HIV-1 infection; Lymphoma; gene therapy; 7shRNA

Outcome Measures

Primary Outcomes (2)

• Overall survival

  Number of patients alive all over the trial

  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.

  within day +28 after gene therapy

Secondary Outcomes (3)

• 7shRNA VCN

  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

  Up to 24 months post-treatment

• Transplantation related mortality

  Up to 24 months post-treatment

Study Arms (1)

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

Drug: KL-7SHRNA injection solution

Interventions

KL-7SHRNA injection solution DRUG

Patients continue to receive HAART throughout treatment until meet the criteria of interruption of HAART.

Also known as: 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

7shRNA modified CD34+stem cells

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital of Guangdong Medical University: lead

Study Sites (1)

Affiliated hospital of Guangdong medical university

Zhanjiang, Guangdong, 524001, China

RECRUITING

MeSH Terms

Conditions

HIV Infections; Lymphoma

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders

Study Officials

• yuming Zhang, PhD

  Affiliated hospital of Guangdong medical university, Guangdong province, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jinqi huang, PhD

CONTACT

+86-0759-2386971; Jinqi@gdmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Hematology Department

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: June 28, 2023
• Study Start: July 5, 2023
• Primary Completion: September 10, 2025
• Study Completion: April 10, 2026
• Last Updated: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)