CLIC-2201 for the Treatment of Relapsed/Refractory B Cell Malignancies

Sponsor
British Columbia Cancer Agency
Study ID
NCT06208735
Phase
PHASE1
Status
Recruiting
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Conditions

  • B-Cell Leukemia
  • B-cell Acute Lymphoblastic Leukemia
  • B-cell Lymphoma
  • Diffuse Large B Cell Lymphoma
  • High-grade B-cell Lymphoma
  • Mantle Cell Lymphoma
  • Non-Hodgkin's Lymphoma
  • Primary Mediastinal Large B-cell Lymphoma (PMBCL)

Eligibility Criteria

Sex
ALL
Age
1 Year - N/A
Healthy Volunteers
Not accepted

Interventions

  • CLIC-2201 — BIOLOGICAL
    Participants will undergo (a) lymphodepletion with cyclophosphamide and fludarabine, followed by (b) infusion of autologous CLIC-2201 CAR-T cells. All treatments will be delivered intravenously.

Study Details

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.

Key Dates

First listed
Jan 17, 2024
Start date
Jan 2, 2025
Status verified
Mar 2026
Primary completion
Aug 1, 2026
Completion
Aug 1, 2027

Study Design

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

Arms

  • Experimental: CLIC-2201
    A single Intravenous infusion of CLIC-2201 will be given.

Primary Outcome Measure

Defining the maximum tolerated dose (MTD) of CLIC-2201 [ Time Frame: Within the first 28 days of CAR-T infusion ]

Central Contacts

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