Study Evaluating UCART20x22 in B-Cell Non-Hodgkin Lymphoma

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Cellectis S.A.
Study ID
NCT05607420
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • B-cell Non-Hodgkin Lymphoma (B-NHL)

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • UCART20x22 — BIOLOGICAL
    Allogeneic engineered T-cells expressing anti-CD20 and anti-CD22 Chimeric Antigen Receptors given following a lymphodepletion regimen
  • CLLS52 — BIOLOGICAL
    A monoclonal antibody that recognizes a CD52 antigen

Study Details

First-in-human, open-label, dose-finding and dose-expansion study of UCART20x22 administered intravenously in subjects with relapsed or refractory B-Cell Non-Hodgkin Lymphoma (B-NHL). The purpose of this study is to evaluate the safety and clinical activity of UCART20x22 and determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D).

Key Dates

Start date
Nov 1, 2022
Status verified
Aug 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

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

Arms

  • Experimental: Dose finding part
    UCART20x22 tested at several dose levels until the Maximum Tolerated Dose (MTD) and/or the Recommended Phase 2 Dose (RP2D) is identified. Dose expansion part: UCART20x22 administered at the RP2D determined during the dose finding part

Primary Outcome Measure

Dose finding and expansion parts: Incidence of adverse events/serious adverse events/dose limiting toxicity [Safety and Tolerability] [ Time Frame: From study entry through month 12 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
The University of Chicago Medical Center (UCMC)ChicagoIllinois60637
Peter Riedell
[email protected]
773-834-5903
Peter Riedell (PRINCIPAL_INVESTIGATOR)
Harvard Medical School - Massachusetts General HospitalBostonMassachusetts02114
Jeremy Abramson
[email protected]
617-724-9190
Jeremy Abramson (PRINCIPAL_INVESTIGATOR)
Rutgers Cancer Institute of New Jersey (CINJ) - New BrunswickNew BrunswickNew Jersey08901
Matthew Matasar
[email protected]
732-439-5162
Matthew Matasar (PRINCIPAL_INVESTIGATOR)
Sarah Cannon - St. David South Austin Medical CenterAustinTexas78704
Aravind Ramakrishnan
[email protected]
512-816-8078
Aravind Ramakrishnan (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By research site
The University of Chicago Medical Center (UCMC)· Chicago, ILHarvard Medical School - Massachusetts General Hospital· Boston, MARutgers Cancer Institute of New Jersey (CINJ) - New Brunswick· New Brunswick, NJSarah Cannon - St. David South Austin Medical Center· Austin, TX

Related Studies