Open-label Dose-finding and Dose-expansion Study to Evaluate the Safety, Expansion, Persistence, and Clinical Activity of UCART20x22 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (B-NHL)

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Relapsed or refractory (R/R) mature B-NHL per 2016 WHO criteria and positive for CD20 and/or CD22

• Subjects with NHL subtypes defined by WHO:

• Dose-Finding Part: R/R mature B-NHL (except chronic lymphocytic leukemia/small lymphocytic leukemia \[CLL/SLL\], Richter's transformation from prior CLL/SLL, Burkitt's lymphoma, and Waldenstrom's macroglobulinemia)

• Dose-Expansion Part: R/R LBCL, defined as:

• i. DLBCL; ii. High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements; iii. Transformed FL or transformed marginal zone lymphoma (MZL); iv. Follicular lymphoma Grade 3B

• R/R disease after at least 2 lines of prior treatment, which must have included:

• An Anti-CD20 MoAb and an anthracycline for DLBCL, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, primary mediastinal large B-cell lymphoma (PMBCL), or transformed FL or MZL

• An alkylating agent in combination with an anti-CD20 MoAb for FL

• An anthracycline or bendamustine-containing chemotherapy regimen and a Bruton's tyrosine kinase (BTK) inhibitor for mantle cell lymphoma (MCL)

• Autologous anti-CD19 CAR T-cell therapy, if approved and available for the indicated lymphoma subtype, unless the subject is unable or is ineligible to receive approved autologous anti-CD19 CAR T-cell therapy (e.g., fail leukapheresis or manufacture, unable to wait for manufacture, CD19 negative disease, etc.)

• Autologous hematopoietic stem cells must be available prior to the start of the LD regimen if the subject is considered high-risk for prolonged hematologic toxicity.

Locations
United States
Illinois
The University of Chicago Medical Center (UCMC)
RECRUITING
Chicago
Massachusetts
Harvard Medical School - Massachusetts General Hospital
RECRUITING
Boston
New Jersey
Rutgers Cancer Institute of New Jersey (CINJ) - New Brunswick
RECRUITING
New Brunswick
Texas
Sarah Cannon - St. David South Austin Medical Center
RECRUITING
Austin
Other Locations
France
Centre Hospitalier Universitaire de Montpellier (CHU Montpellier) - Hopital Saint-Eloi
RECRUITING
Montpellier
Centre Hospitalier Universitaire de Nantes (CHU de Nantes)-Hotel-Dieu
RECRUITING
Nantes
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Saint-Louis - Centre Integre en Cancerologie
RECRUITING
Paris
Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud
RECRUITING
Pierre-bénite
Spain
Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Pamplona
RECRUITING
Pamplona
Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS)
RECRUITING
Seville
Contact Information
Primary
Cellectis Central Contact
clinicaltrials@cellectis.com
+1 917 580-1088
Time Frame
Start Date: 2022-11-01
Estimated Completion Date: 2027-08
Participants
Target number of participants: 80
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Cellectis S.A.

This content was sourced from clinicaltrials.gov

Similar Clinical Trials