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

First listed
Oct 28, 2021
Start date
Dec 21, 2021
Status verified
Jul 2026
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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