Metabolically Fit CD19 CAR T-cell Therapy With CD34 Selection in Patients With CD19+ Relapsed/Refractory NHL, CLL/SLL

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT05702853
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Cyclophosphamide injection — DRUG
    500 mg/m2 IV over 30-60 minutes +/- 10 minutes before Fludarabine Days -5, -4, - 3
  • Fludarabine Injection — DRUG
    30 mg/m2 IV over 30-60 minutes +/- 10 minutes after cyclo- phosphamide infusion Days -5, 4, -3
  • CD19-CD34t metabolically programmed CAR transduced T-cells — BIOLOGICAL
    Cells are to be infused intravenously (IV) over 30 minutes or less via nonfiltered tubing either by gravity or a peristaltic pump, gently agitating the bag during infusion to prevent cell clumping

Study Details

This is a single-center, nonrandomized, open-label dose-escalation study followed by dose-expansion of CD19- CD34t metabolically programmed CAR T-cell therapy in adult patients with relapsed or refractory CD19 B-cell non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

Key Dates

Start date
Nov 6, 2023
Status verified
Feb 2026
Primary completion
Nov 6, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
27 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level 1
    1 x 10\^6 transduced T cells/kg (± 20%)
  • Experimental: Dose Level 2
    1.5 x 10\^6 transduced T cells/kg (± 20%)
  • Experimental: Dose Level 3
    2 x 10\^6 transduced T cells/kg (± 20%)

Primary Outcome Measure

MTD/MAD/RP2D evaluation [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hollings Cancer Center at Medical University of South CarolinaCharlestonSouth Carolina29425
HCC Clinical Trials Office
[email protected]
843-792-9321
Brian Hess, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Charleston, SC

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Hollings Cancer Center at Medical University of South Carolina· Charleston, SC

Related Studies