Cal 1-modified HSPC / CSL Behring - LARVOL DELTA

GENHIV: A Study Evaluating the Safety of Cal-1 (LVsh5/C46) Drug Product in HIV-1 Infected Patient With High Risk Lymphoma (clinicaltrials.gov) - P1/2 | N=2 | Completed | Sponsor: Assistance Publique - Hôpitaux de Paris | Recruiting ➔ Completed

Trial completion • Gene Therapies • Hematological Malignancies • Human Immunodeficiency Virus • Infectious Disease • Lymphoma • Oncology • CD34 • CD4 • CD8

Gene-Modified HIV-Protected Stem Cell Transplant in Treating Patients With HIV-Associated Lymphoma (clinicaltrials.gov) - P1; N=5; Not yet recruiting; Sponsor: Fred Hutchinson Cancer Research Center; Initiation date: Nov 2015 ➔ Apr 2016

Trial initiation date • Biosimilar • Gene Therapies • Hematological Malignancies • Immunology • Non-Hodgkin’s Lymphoma • Oncology

Safety Study of a Dual Anti-HIV Gene Transfer Construct to Treat HIV-1 Infection (clinicaltrials.gov) - P1/2; N=12; Active, not recruiting; Sponsor: Calimmune, Inc.; Recruiting ➔ Active, not recruiting

Enrollment closed • Biosimilar • Gene Therapies • Human Immunodeficiency Virus

[VIRTUAL] PHASE I STUDY OF GENE-MODIFIED CD4+ CELLS AND CD34+ CELLS W/WO BUSULFAN IN HIV+ ADULT (CROI 2020) - "Safety and feasibility of an anti-HIV-1 dual-gene construct LVsh5/C46 (Cal-1) in modified, autologous CD4+ T-cells (Ttn) and HSC (HSCtn) was assessed. Potential reasons for the lack of long-term survival of Cal-1 transduced cells include persistent HIV viremia and inflammation. Future research should focus on administering gene-modified stem cells in fully-suppressed individuals"

Clinical • P1 data • CD34

Long Term Follow up for the Detection of Delayed Adverse Events in Cal-1 Recipients (clinicaltrials.gov) - P=N/A; N=11; Active, not recruiting; Sponsor: Calimmune, Inc.; Enrolling by invitation ➔ Active, not recruiting; N=18 ➔ 11

Adverse events • Enrollment change • Enrollment closed

Safety of CD34 Hematopoietic Stem Cells and CD4 T Lymphocytes Transduced with LVsh5/C46 in HIV-1 Infected Patients with High-Risk Lymphoma. (PubMed, Mol Ther Methods Clin Dev) - "We plan to enroll five HIV-1-infected patients presenting with high-risk lymphoma and require a treatment with ASCT. The primary objective of this study is to evaluate the safety, feasibility, and success of engraftment of Cal-1 gene-transduced CD4 T lymphocytes and CD34 HSPCs."

Clinical • Journal

GENHIV: A Study Evaluating the Safety of Cal-1 (LVsh5/C46) Drug Product in HIV-1 Infected Patient With High Risk Lymphoma (clinicaltrials.gov) - P1/2; N=5; Recruiting; Sponsor: Assistance Publique - Hôpitaux de Paris; Not yet recruiting ➔ Recruiting; Trial completion date: Jun 2023 ➔ Jan 2024; Initiation date: Jul 2018 ➔ Jan 2019; Trial primary completion date: Jun 2023 ➔ Jan 2022

Clinical • Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date