CLIC-2201 for the Treatment of Relapsed/Refractory B Cell Malignancies
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This is a phase I dose-finding trial of an autologous CD22 targeting chimeric antigen receptor (CAR)-T cell product, called CLIC-2201, for participants with relapsed/refractory B cell malignancies. In the proposed trial, eligible enrolled participants will undergo leukapheresis for autologous T cell collection to enable CLIC-2201 manufacturing, followed by lymphodepletion with cyclophosphamide and fludarabine, then intravenous infusion of the autologous CLIC-2201 product. The trial will use the 3+3 design to escalate or de-escalate the dose level of CLIC-2201 administered. Participants will be monitored for safety and tolerability up to day 365 following CLIC-2201 infusion. The primary objective is to evaluate the safety and tolerability of CLIC-2201 and estimate the maximum tolerated dose (MTD) of CLIC-2201 in B-cell malignancies. The secondary objectives are to evaluate the (i) feasibility; (ii) anti-tumour activity of CLIC-2201; (iii) and characterize the pharmacokinetic (PK) profile of CLIC-2201. Exploratory objectives will include: i) characterizing the cellular and humoral immune responses against CLIC-2201 up to 1 year following infusion of CLIC-2201; (ii) characterizing the phenotype and gene expression profile of CLIC-2201 cells; (iii) evaluating immune and tumour cells at baseline and relapse for biomarkers of response or toxicity; (iv) evaluating serum cytokines, circulating tumour DNA (ctDNA) and B cell aplasia as biomarkers of clinical outcomes; and (v) assessing the quality of life.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18 lat lub więcej
- •Potwierdzony nawrotowy lub oporny chłoniak z komórek B (DLBCL, chłoniak pierwotnie śródpiersiowy, chłoniak płaszcza lub inne pokrewne)
- •Wcześniejsze leczenie co najmniej dwoma liniami terapii lub nawrót po przeszczepie szpiku kostnego lub terapii CAR-T
- •Prawidłowe funkcjonowanie serca, nerek i wątroby
- •Sprawność fizyczna pozwalająca na uczestnictwo w badaniu
- •Gotowość do stosowania antykoncepcji przez rok od podania leku
Simplified criteria — AI translation
Trial details
- Minimum age
- 1 Year
- Last updated (source)
- October 14, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (7)
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Canada
Alberta Children's Hospital
Calgary, Canada
Vancouver General Hospital
Vancouver, Canada
BC Children's Hospital
Vancouver, Canada
The Ottawa Hospital - General Campus
Ottawa, Canada
Princess Margaret Cancer Centre
Toronto, Canada
The Hospital for Sick Children
Toronto, Canada
Trial contact
Kevin Hay, MD
Narsis Afghari, MSc
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/15/2026.
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