Evaluating the Safety and Efficacy of DuoCAR20.19.22-D95 in Adult Patients With Relapsed or Refractory B-cell Malignancies

Part of paid clinical trials in Westwood, Kansas.

Sponsor
University of Kansas Medical Center
Study ID
NCT06879340
Phase
PHASE1
Status
Recruiting
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Conditions

  • B-Cell Non-Hodgkin Lymphoma
  • B-cell Acute Lymphoblastic Leukemia

Eligibility Criteria

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

Interventions

  • DuoCAR20.19.22-D95 — DRUG
    Patient derived autologous T cells, lentiviral transduced to generate, using the Miltenyi CliniMACS Prodigy® closed transduction system, a Duo-CAR-T cells targeting cell surface antigens CD19/20/22.
  • Fludarabine (Conditional therapy) — DRUG
    Lymphodepletion chemotherapy
  • Cyclophosphamide (Conditional therapy) — DRUG
    Lymphodepletion chemotherapy

Study Details

This multicenter phase 1 trial with "3 + 3" dose escalation design seeks to examine the feasibility and safety of the administration of autologous T cells that have been modified through the introduction of chimeric antigen receptors targeting the B cell surface antigens CD19/20/22 following administration of a chemotherapy lymphodepletion regimen in adults with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) or Non-Hodgkin's lymphoma (NHL). The overall goals of this study are to estimate maximum tolerated dose (MTD) level, establish the overall safety profile and evaluate initial efficacy of administering duo-CAR-T cell treatment in this patient population.

Key Dates

Start date
Mar 31, 2025
Status verified
May 2026
Primary completion
Mar 31, 2030
Completion
Mar 31, 2040

Study Design

Enrollment
54 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 (Dose Escalation)
    Lymphodepletion: Fludarabine: Days -6 to -3 (4 days total) Cyclophosphamide: Days -6 and -5 (2 days total) Investigational Treatment: DuoCAR20.19.22-D95 will be infused on day # 0 Patients will receive lymphodepletion chemotherapy and receive the CAR T cell infusion on day 0 (or up to day +14 in extenuating clinical conditions). Patients will be hospitalized inpatient period of at least 7 days from the day of the CAR T infusion.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: Approximately 30 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Kansas Cancer CenterWestwoodKansas66205
Nurse Navigation
[email protected]
913-945-7552
Joseph McGuirk, DO (PRINCIPAL_INVESTIGATOR)

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By research site
University of Kansas Cancer Center· Westwood, KS

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