Cal 1-modified HSPC
/ CSL Behring
- LARVOL DELTA
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November 07, 2022
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
February 23, 2016
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
November 29, 2016
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
March 02, 2020
[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
August 01, 2019
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
March 28, 2019
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
February 19, 2019
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
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