Dose finding part for Non-Hodgkin Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Non-Hodgkin LymphomaUCART20x22 - Biological
Eligibility
18 - 80
All Sexes
What conditions do you have?
Select

Study 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).

Eligible Conditions
  • Non-Hodgkin Lymphoma

Treatment Effectiveness

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: From initiation of any study treatment to death from any cause, assessed up to Year 15

Month 12
Lymphoma
Month 12
Duration of Response
Year 15
Overall survival
Month 12
Dose finding and expansion parts: Incidence of adverse events/serious adverse events/dose limiting toxicity [Safety and Tolerability]
Month 12
Progression-free survival (PFS)
Day 28
Dose finding part: Occurrence of Dose Limiting Toxicities (DLTs)

Trial Safety

Trial Design

1 Treatment Group

Dose finding part
1 of 1

Experimental Treatment

80 Total Participants · 1 Treatment Group

Primary Treatment: Dose finding part · No Placebo Group · Phase 1 & 2

Dose finding partExperimental Group · 2 Interventions: UCART20x22, CLLS52 · Intervention Types: Biological, Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from initiation of any study treatment to death from any cause, assessed up to year 15

Who is running the clinical trial?

Cellectis S.A.Lead Sponsor
5 Previous Clinical Trials
124 Total Patients Enrolled
Jeremy Abramson, MDPrincipal InvestigatorMassachusetts General Hospital
6 Previous Clinical Trials
175 Total Patients Enrolled

Eligibility Criteria

Age 18 - 80 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
-An alkylating agent in combination with an anti-CD20 MoAb for FL.
You have a performance status of 0 or 1.