Preliminary Safety and Tolerability of CD19x22 CAR T Cells in Adolescent and Adult R/R B-NHL Patients

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT05098613
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • CD19x22 CAR T Cells — DRUG
    Autologous peripheral blood mononuclear cells transduced with CD19x22 CAR T lentiviral vector.

Study Details

This open-label, single arm phase 1 trial aims to determine the safety and tolerability of anti-CD19 and anti-CD22 chimeric antigen receptor-expressing (CAR) T cells (CD19x22 CAR T) in adolescents and adults with relapsed/refractory (R/R) B-cell Non-Hodgkin Lymphoma (B-NHL). This trial will determine the maximum tolerated dose of CD19x22 CAR T cells using a standard 3+3 trial design.

Key Dates

Start date
Dec 21, 2021
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
68 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 Relapsed/Refractory Non-CNS B-Cell Non Hodgkin Lymphoma
    Lymphodepleting chemotherapy followed by infusion of CD19x22 CAR T Cells starting at dose level 1.
  • Experimental: Cohort 2 Relapsed/Refractory Mantle Cell Lymphoma
    Lymphodepleting chemotherapy followed by CD19x22 CART Infusion starting at dose level 2.
  • Experimental: Cohort 3: Relapsed and/or Refractory Primary CNS Lymphoma OR secondary CNS Lymphoma
    Lymphodepleting chemotherapy followed by CD19x22 CAR T Infusion starting at dose level 2

Primary Outcome Measure

Overall safety and tolerability of CD19x22 CAR T Therapy in CAR-naive and CAR-treated subjects [ Time Frame: 12 Months Post Infusion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado HospitalAuroraColorado80045
Manali Kamdar, MD
[email protected]
720-848-0752

Find similar trials in Aurora, CO

By research site
University of Colorado Hospital· Aurora, CO

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