Testing CLIC-2201 for b-cell leukemia
Official title: CLIC-2201 for the Treatment of Relapsed/Refractory B Cell Malignancies
CLIC-02: A Phase I Trial of CLIC-2201 for the Treatment of Relapsed/Refractory B Cell Malignancies
Interventions
CLIC-2201
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.
Canadian Sites (7)
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
Alberta Children's Hospital
Calgary, Alberta, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
BC Children's Hospital
Vancouver, British Columbia, Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Eligibility Criteria
See who this study is looking for61 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Participants in the cohortCohortA group of participants sharing a characteristic, followed together.Read more → B must be between 1-39 years of age at the time of consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
- +in Cohort A:
- +Participants must meet the following criteria to be enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → on the trial:
- +Participants in the cohort A must be 18 years of age or older of age at time of informed consent.
- +Participants must provide written informed consent.
- +Participants must have a relapsed or refractory B cell lymphoma, including one of the following:
- +diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS),
- +high grade B cell lymphoma NOS,
- +high grade B cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements,
- +primary mediastinal large B-cell lymphoma (PMBCL),
- +aggressive B cell lymphoma transformed from an indolent lymphoma,
- +mantle cell lymphoma (MCL),
- +Participants must have refractory or relapsed disease, defined as one of the following:
- +Relapse or refractory disease after at least 2 lines of therapy, OR
- +Any relapse after autologous or allogeneic hematopoietic cell transplantation (HCT), OR
- +Any relapse after CAR-T cell therapy.
- +Participants must have adequate organ function at enrolment, defined as:
- +Left ventricular ejection fraction (LVEF) ≥40%,
- +Creatinine clearance using Cockcroft-Gault of \> 30 mL/min, AND
- +ALP/ALT \< 5X upper limit of normal (ULN), conjugated bilirubin \< 2X ULN, and no evidence or history of liver cirrhosis.
- +Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 or Karnofsky Score ≥50%.
- +Participants with accessible disease, must be willing to undergo a tumour biopsy at enrolment. For participants with a recent (within 3 months) tumor biopsy, access to the archival biopsy is acceptable.
- +Inclusion CriteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → in Cohort B:
- +For participants who are under the age of consent as defined by REBResearch Ethics Board (REB)The independent committee that must approve a study before it can run.Read more → requirements, parent or legal guardian of the participant must provide the informed consent and the participant's assent/consent must be obtained (if applicable).
- +Participants must have a relapsed or refractory B cell acute lymphoblastic leukemia (B-ALL).
- +Participants must have refractory or relapsed disease, defined as one of the following:
- +Relapse or refractory disease after at least 2 lines of therapy, OR
- +Any relapse after autologous or allogeneic hematopoietic cell transplantation (HCT), OR
- +Any relapse after CAR-T cell therapy.
- +Participants must have adequate organ function at enrolment, defined as:
- +Left ventricular ejection fraction (LVEF) ≥45%,
- +Creatinine clearance using Cockcroft-Gault or Schwartz equation of \> 30 mL/min, AND
- +ALP/ALT \< 5X upper limit of normal (ULN), conjugated bilirubin \< 2X ULN, and no evidence or history of liver cirrhosis.
- +Participants must have a Karnofsky or Lansky Score ≥50%.
- +Participants must be willing to undergo a bone marrow biopsy at enrolment.
- +Females of child-bearing potential and sexually active males must agree to use a highly effective contraception method (see section 5.4) through to at least one year following administration of the CLIC-2201 product.
- +Participants of reproductive age must agree to use a highly effective contraception method (see section 5.4) through to at least one year following administration of the CLIC-2201 product.
- +Participants in cohort B and/or those who have received CD22 targeted therapy must have documentation of CD22 tumour expression within the 6 months prior to study screeningScreeningThe checks done before joining, to see whether a study fits.Read more →, and after any prior CD22 directed therapy (if applicable).
Exclusion
- −Hypersensitivity to fludarabine or cyclophosphamide.
- −Any allergy to gentamycin or its derivatives
- −Active (confirmed by PCR) hepatitis B or hepatitis C at time of screeningScreeningThe checks done before joining, to see whether a study fits.Read more → confirmed by PCR.
- −Any Human Immunodeficiency Virus (HIV) infection at time of screening.
- −Any uncontrolled or serious active infection at the time of enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more →.
- −Active autoimmune disease requiring immunosuppressive therapy within 4 weeks of enrolment.
- −Live vaccine ≤6 weeks prior to enrolment
- −Active Graft Versus Host Disease (GVHD) requiring systemic immunosuppressive therapy within 4 weeks of enrolment.
- −Diagnosis of primary central nervous system lymphoma (PCNSL)
- −Treatment with any of the following in the specified time period before leukapheresis:
- −Allogeneic HCT within 3 months,
- −Autologous HCT within 3 months,
- −CD19 CAR-T cell infusion within 3 months,
- −Donor lymphocyte infusion (DLI) within 3 months,
- −Bendamustine within the last 6 months,
- −Any investigational agent within 30 days or 5 half-lives (whichever is shorter),
- −Systemic administration of therapeutic dose corticosteroids (\>20 mg/day prednisone or equivalent for adults and ≥ 12 mg/m2/day for paediatric participants) within 7 days prior to leukapheresis.
- −Immunosuppressive therapies (i.e., calcineurin inhibitors, methotrexate, mycophenolate, rapamycin) within 4 weeks, unless used as treatment for the B cell malignancy.
- −Other concurrent malignancy or a prior malignancy treated within the past 2 years, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease.
- −Concomitant genetic syndrome associated with bone marrow failure such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure or immunodeficiency syndrome.
- −Participants who do not meet the minimum weight requirement for the planned dose level.
- −Pregnant or nursing participants.
- −Oral chemotherapy agents (i.e., venetoclax) within 5 half-lives. An exception to this is that bruton tyrosine kinase (BTK) inhibitors like ibrutinib can be continued in participants with mantle cell lymphoma throughout the trial period.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more → — an early safety study in a small group, checking how it is tolerated and at what dose.
What is being given or done in this study: CLIC-2201.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
There is one group in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 1 year, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 24 people.
The study is currently expected to finish around August 2027.
The main measurement is taken over: Within the first 28 days of CAR-T infusion.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Defining the maximum tolerated doseMaximum tolerated doseThe highest amount that can be given before side effects become unacceptable.Read more → (MTD) of CLIC-2201 — measured over Within the first 28 days of CAR-T infusion.
Proportion of participants who experienced any grade of CRS to define the safety of CLIC-2201 — measured over Within the first 28 days of CAR-T infusion.
Proportion of participants who experienced any grade of ICANs to define the safety of CLIC-2201 — measured over Within the first 28 days of CAR-T infusion.
Proportion of participants who experienced any grade of IEC-HS to define the safety of CLIC-2201 — measured over Within the first 28 days of CAR-T infusion.
The study lists 2 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06208735 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About CLIC-2201Biological
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.
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 1 year.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 1 year, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Within the first 28 days of CAR-T infusion.
The study as a whole is currently expected to finish around 2027-08-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 24 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 4 locations, including: Calgary, Alberta, Canada; Vancouver, British Columbia, Canada; Ottawa, Ontario, Canada; Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This 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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.