Clinical trial · Interventional
HIV-Resistant Gene Modified Stem Cells and Chemotherapy in Treating Patients With Lymphoma With HIV Infection
A Clinical Trial of Gene-Modified Stem Cells to Generate HIV-Resistant Cells in Conjunction With Standard Chemotherapy for Treatment of Lymphoma in Patients With HIV Infection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Administrative closure prior to any enrollments
Summary
Brief summary (as posted)
This pilot phase I trial studies the side effects and best dose of human immunodeficiency virus (HIV)-resistant gene modified stem cells in treating HIV-positive patients who are undergoing first-line treatment for Hodgkin or Non-Hodgkin Lymphoma. Stem cells are collected from the patient and HIV-resistance genes are placed into the stem cells. The stem cells are then re-infused into the patient. These genetically modified stem cells may help the body make cells that are resistant to HIV infection.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Immunodeficiency Virus 1 Positive | — | UNRESOLVED | — |
| Stage I Adult Hodgkin Lymphoma | Adult Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Stage I Adult Non-Hodgkin Lymphoma | Adult Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Stage II Adult Hodgkin Lymphoma | Adult Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Stage II Adult Non-Hodgkin Lymphoma | Adult Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Stage III Adult Hodgkin Lymphoma | Adult Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
| Stage III Adult Non-Hodgkin Lymphoma | Adult Non-Hodgkin Lymphoma | CURATED_BROADER |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| C46/CCR5/P140K Lentiviral Vector-transduced Autologous HSPCs | Biological | — | UNRESOLVED |
| Carmustine | Drug | Carmustine | ALIAS |
| Filgrastim | Biological | Filgrastim | ALIAS |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| O6-Benzylguanine | Drug | O6-Benzylguanine | ALIAS |
| Plerixafor | Drug | Plerixafor | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (gene modified HPSC)
- description
- See Detailed Description.
- interventionNames
- Biological: C46/CCR5/P140K Lentiviral Vector-transduced Autologous HSPCs
- Drug: Carmustine
- Biological: Filgrastim
- Other: Laboratory Biomarker Analysis
- Drug: O6-Benzylguanine
- Drug: Plerixafor
Primary outcomes (8)
- measure
- Feasibility of collection: defined as collection of >= 4.0 x 10^6 CD34+ cells/kg for genetic modification
- timeFrame
- Up to 28 days after completion of last course of first line treatment for lymphoma
- measure
- Feasibility of infusion of gene modified cells: defined as engraftment of >= 1% gene modified cells
- timeFrame
- Up to 28 days after infusion of gene-modified cells to 15 years post-transfusion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 66 Years
Show eligibility criteria text
Inclusion Criteria: * HIV-1 seropositive * Stable, continuous antiretroviral treatment, defined as a multi-drug regimen (excluding zidovudine, also known as azidothymidine \[AZT\], Retrovir) prior to enrollment, as demonstrated by HIV plasma viral load \< 50 copies/mL * Previously untreated non-Hodgkin lymphoma or Hodgkin lymphoma; all stages of disease are allowed; also eligible are patients who have started or completed one or more cycles of treatment as part of a planned first line regimen, or those who have received local radiation or surgery or corticosteroids for disease control * Planned treatment with standard first line therapy for non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL) * Karnofsky performance score \>= 70% * Subjects must agree to use effective means to prevent conception from enrollment through completion of the study * Female subjects: if of child bearing potential, must have negative serum or urine pregnancy test within 7 days of enrollment * Subjects must be on a prophylactic regimen for Pneumocystis jiroveci pneumonia, or agree to begin such treatment, if CD4+ cell counts are observed to be =\< 200/ul in peripheral blood * Able to understand, and the willingness to give, informed consent for the study Exclusion Criteria: * Central nervous system (CNS) lymphoma: CNS involvement by lymphoma, including parenchymal brain or spinal cord lymphoma or known presence of leptomeningeal disease prior to registration * Patients with renal, hepatic, pulmonary, or cardiac disease that exclude delivery of standard chemotherapy * Active (uncontrolled) infection requiring systemic antibiotic therapy with antibacterial, antifungal, or antiviral agents (excluding HIV) * Hepatitis B surface antigen positive * Hepatitis C virus (HCV) antibody positive and detectable HCV quantitative ribonucleic acid (RNA), with clinical evidence of cirrhosis as determined by the principal investigator * Requiring active treatment for Toxoplasma gondii infection * 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 * History of HIV-associated encephalopathy; dementia of any kind; seizures in the past 12 months * Any perceived inability to directly provide informed consent (note: consent may not be obtained by means of a legal guardian) * Any concurrent or past medical condition that, in the opinion of the investigator, would exclude the subject from participation * Patients who have received a vaccine for HIV-1 or any prior gene modified cell product, at any time * A medical history of noncompliance with HAART or medical therapy * Pregnant women or nursing mothers * Use of zidovudine as part of the HAART regimen (a drug substitution for zidovudine at the time of study entry is allowed) * Known hypersensitivity to any of the products used in the trial - G-CSF (Neupogen, filgrastim), plerixafor (Mozobil), or any components of the chemotherapeutic agents or O6BG/BCNU in vivo selection regimens
References
Publications (0)
Data not yet available