Health TrialsbyHealthPanel

Study Evaluating UCART20x22 in B-Cell Non-Hodgkin Lymphoma

ConditionB-cell Non-Hodgkin Lymphoma (B-NHL)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCellectis S.A.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

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)

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

Disqualifiers

Prior use of an investigational product (except for cell or gene therapies and MoAbs) within 5 half-lives or within 14 days, whichever is shorter, prior to start of LD regimen

Previous approved therapy including chemotherapy, biologic (except MoAbs), or targeted therapy for R/R B-NHL with 5 half-lives or within 14 days, whichever is shorter, prior to start of the LD regimen

> 4 lines of therapy R/R B-NHL prior to start of the LD regimen.

Prior MoAb therapy (approved or investigational) within 30 days prior to start of LD

Trial design

Design model

Single group

Treatments tested in this trial

  • UCART20x22

    Biological/Vaccine

    Allogeneic engineered T-cells expressing anti-CD20 and anti-CD22 Chimeric Antigen Receptors given following a lymphodepletion regimen

  • CLLS52

    Biological/Vaccine

    A monoclonal antibody that recognizes a CD52 antigen

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Dose finding partExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Dose finding and expansion parts: Incidence of adverse events/serious adverse events/dose limiting toxicity [Safety and Tolerability]

Incidence, nature and severity of adverse events and serious adverse events in relation to UCART20x22 and/or lymphodepletion

Time frame
From study entry through month 12
2

Dose finding part: Occurrence of Dose Limiting Toxicities (DLTs)

Time frame
Up to Day 28 post UCART20x22 infusion

Secondary outcomes

1

Investigator assessed overall response rate (ORR) according to Lugano Response Criteria for Malignant Lymphoma

Time frame
At Day 28, Day 84, Month 6, Month 9, Month 12
2

Duration of Response

Time frame
From achievement of the initial response to disease relapse/progression or death from any cause, assessed up to Month 12
3

Progression-free survival (PFS)

Time frame
From the first day of any study treatment to the date of disease progression or death from any cause, whichever occurs first, assessed up to Month 12
4

Overall survival

Time frame
From initiation of any study treatment to death from any cause, assessed up to Year 15

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cellectis S.A.

Lead sponsor

Source ClinicalTrials.gov
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