LV20.19 CAR T-Cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT05990465
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Burkitt Lymphoma
  • Diffuse Large B Cell Lymphoma
  • Follicular Lymphoma
  • Mantle Cell Lymphoma
  • Marginal Zone Lymphoma
  • Non Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 81 Years
Healthy Volunteers
Not accepted

Interventions

  • Pirtobrutinib — DRUG
    Pirtobrutinib will be administered at 200 mg/day orally starting at least 14 days prior to apheresis as bridging until the start of lymphodepletion and restarted between day 28-120 for up to one year as maintenance post cell infusion.
  • LV20.19 CAR T cells — DRUG
    Subjects will receive a dose of 2.5x10\^6 CAR-T cells/kg as a previously identified safe in a Phase 1 protocol at the Medical College of Wisconsin.

Study Details

This is a phase I, interventional, single arm, open label, treatment study designed to evaluate the safety and efficacy of LV20.19 CAR -T cells with pirtobrutinib bridging and maintenance in adult patients with B cell malignancies that have failed prior therapies.

Key Dates

Start date
Feb 6, 2025
Status verified
Feb 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2027

Study Design

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

Arms

  • Experimental: Pirtobrutinib and CAR T Cells
    Pirtobrutinib is an oral agent. LV20.19 CAR T cells will be administered either fresh or thawed after cryopreservation by IV injection.

Primary Outcome Measure

Number of Adverse Events After CAR 20/19-T Cell Infusion [ Time Frame: Up until 28 days after infusion ]

Central Contacts

  • Medical College of Wisconsin Cancer Center Clinical Trials Office
    866-680-0505
    [email protected]

Locations (1)

FacilityCityStateZIPSite coordinators
Froedtert & the Medical College of WisconsinMilwaukeeWisconsin53226
Nirav Shah, MD
[email protected]
414-805-4400

Find similar trials in Milwaukee, WI

By research site
Froedtert & the Medical College of Wisconsin· Milwaukee, WI

Related Studies