A Phase I Study of Chemotherapy and Stem Cell Gene Therapy for People with HIV Who Developed Lymphoma

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Full Title

A Phase I Study of Stem Cell Gene Therapy for HIV Mediated by Lentivector Transduced, Pre-selected CD34+ Cells (AMC 097)

Purpose

This study is for people who are HIV-positive, have lymphoma that persists despite chemotherapy, and are eligible for a transplant of their own stem cells (autologous stem cell transplantation or ASCT). Researchers want to see if ASCT plus gene therapy that contains anti-HIV genes is safe for these patients.

During ASCT, a patient’s own blood-forming stem cells are collected, and he or she is then treated with high doses of chemotherapy. Afterward, the collected stem cells are re-infused back into the patient to re-establish the blood-forming system. In this study, the researchers will add parts of anti-HIV genes to the collected stem cells to make the gene therapy. It is possible that the gene therapy may “recharge” the immune system and make it strong enough to fight the spread of HIV infection without the need for additional HIV medications.

All participants in this study will receive the same high-dose chemotherapy. However, different groups of study participants will have different amounts of anti-HIV genes added to their stem cell infusion, depending on when they join the study.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must be HIV-positive and have Hodgkin or non-Hodgkin lymphoma that persists despite chemotherapy.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Craig Sauter at 212-639-3460.

Protocol

19-029

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators