Pilot Study of Anti-CD19 Chimeric Antigen Receptor T Cells (CAR-T Cells) for the Treatment of Relapsed/Refractory CD19+ Malignancies

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT06227026
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Anti-CD19 CAR-T cells — BIOLOGICAL
    Anti-CD19 CAR-T cells are autologous T cells, engineered to express an extracellular single chain variable fragment (scFv) derived from a murine anti-human CD19 hybridoma clone FMC63 linked in frame to hinge region derived from human CD8, transmembrane domain derived from Tumor Necrosis Factor Receptor Super Family 19 (TNFRSF19) the transactivation costimulatory domain 4-1BB, and CD3 zeta signaling domain (Miltenyi Biotec Inc). Anti-CD19 CAR-T cells will be cryopreserved in infusible cryomedia for a later infusion. Anti-CD19 CAR-T cells will be administered in 1 to 3 bags. Bag aliquoting, cell content and cryomedia composition will be done according to specifications in the CMC.

Study Details

This is an open label, non-randomized, phase 1 study of anti-CD19 CAR-T cells against relapsed CD19 positive NHL, CLL and ALL based in a lymphodepletion regimen (fludarabine and cyclophosphamide) and using a CellReGen-based process for manufacturing CAR-T cells. This study will utilize a staggered enrollment design with a safety observation period.

Key Dates

Start date
Feb 20, 2024
Status verified
Feb 2026
Primary completion
Jul 31, 2026
Completion
May 31, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Anti-CD19 CAR-T Cell Infusion

Primary Outcome Measure

Production and infusion of CAR-T therapy in 5/6 patients who have undergone successful apheresis and no more than 3/6 patients with ≥ grade 3 non-hematological CAR-T related toxicities or events of special interest within 28 days of CAR-T administration. [ Time Frame: 28 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Huntsman Cancer InstituteSalt Lake CityUtah84112
Catherine Cromar
[email protected]
801-213-5652
Sagar Patel, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Salt Lake City, UT

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Huntsman Cancer Institute· Salt Lake City, UT

Related Studies