B-Cell Leukemia study: CLIC-2201
Official title CLIC-2201 for the Treatment of Relapsed/Refractory B Cell Malignancies
ClinicalTrials.gov ID: NCT06208735
What this study is testing
What is CLIC-2201?
This is an investigational treatment being studied for B-cell leukemia. It is designed to use your own immune cells, which are changed in a lab to recognize and attack cancer cells that have a specific marker called CD22.
Also referred to as Autologous CD22 targeting CAR-T cells.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find the highest safe dose of the new treatment and check if it is safe to use.
- Who it's for
- People with B-cell cancers, such as certain leukemias or lymphomas, that have returned or stopped responding to other treatments.
- What's involved
- Participants will have their own immune cells collected, modified in a lab, and then infused back into their body after receiving chemotherapy to lower their immune system.
- Time commitment
- The study involves follow-up visits and monitoring for up to one year after the treatment infusion.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 and older
You may be able to join if
- 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.
- 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,
You likely can't join if
- Any uncontrolled or serious active infection at the time of enrolment.
- 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)
- Allogeneic HCT within 3 months,
See the full eligibility criteria
- 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.
- 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),
- 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.
- Left ventricular ejection fraction (LVEF) ≥ 45%, and no current evidence of significant cardiac dysfunction.
- 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%.
- 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 in the cohort B must be between 1-39 years of age at the time of consent.
- For participants who are under the age of consent as defined by REB requirements, parent or legal guardian of the participant must provide the informed consent and the participant's assent/consent must be obtained (if...
- Participants must have a relapsed or refractory B cell acute lymphoblastic leukemia (B-ALL).
- 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 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 screening, and after any prior CD22 directed therapy (if...
- Left ventricular ejection fraction (LVEF) ≥ 45%, and no current evidence of significant cardiac dysfunction.
- 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 of reproductive age must agree to use a highly effective contraception method through to at least one year following administration of the CLIC-2201 product.
- Participants must be willing to undergo a bone marrow biopsy at enrolment.
- Any uncontrolled or serious active infection at the time of enrolment.
- 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)
- 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.
- 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...
- 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.
- Active (confirmed by PCR) hepatitis B or hepatitis C at time of screening confirmed by PCR.
- Any Human Immunodeficiency Virus (HIV) infection at time of screening.
- Hypersensitivity to fludarabine or cyclophosphamide.
- Any allergy to gentamycin or its derivatives
- Participants who do not meet the minimum weight requirement for the planned dose level.
- Pregnant or nursing participants.
The study team makes the final eligibility decision.
Where it is enrolling
- Calgary, Alberta, Canada
- Vancouver, British Columbia, Canada
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Calgary, Alberta, Canada; Vancouver, British Columbia, Canada; Ottawa, Ontario, Canada; Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.