Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-24 @ 10:19 PM
NCT ID:
NCT06208735
Eligibility Criteria:
Inclusion Criteria in Cohort A:
Participants must meet the following criteria to be enrolled on the trial:
1. Participants in the cohort A must be 18 years of age or older of age at time of informed consent.
2. Participants must provide written informed consent. The investigator is responsible for obtaining written informed assent/consent for the subject after adequate explanation of the study design, anticipated benefits and the potential risks. Subjects should sign the most current REB approved assent/consent prior to any study specific activity or procedure is performed. (Sites will follow their REB board requirements for consenting).
3. Participants must have a relapsed or refractory B cell lymphoma, including one of the following:
1. diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS),
2. high grade B cell lymphoma NOS,
3. high grade B cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements,
4. primary mediastinal large B-cell lymphoma (PMBCL),
5. aggressive B cell lymphoma transformed from an indolent lymphoma,
6. mantle cell lymphoma (MCL),
4. Participants must have refractory or relapsed disease, defined as one of the following:
1. Relapse or refractory disease after at least 2 lines of therapy, OR
2. Any relapse after autologous or allogeneic hematopoietic cell transplantation (HCT), OR
3. Any relapse after CAR-T cell therapy.
5. Participants must have adequate organ function at enrolment, defined as:
1. Left ventricular ejection fraction (LVEF) ≥40%,
2. Creatinine clearance using Cockcroft-Gault of \> 30 mL/min, AND
3. ALP/ALT \< 5X upper limit of normal (ULN), conjugated bilirubin \< 2X ULN, and no evidence or history of liver cirrhosis.
6. Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 or Karnofsky Score ≥50%.
7. 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.
8. Participants with accessible disease, willingness 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 Criteria in Cohort B:
1. Participants in the cohort B must be between 1-21 years of age at the time of consent.
2. Parent or legal guardian of the participant signed the informed consent and the participant's assent/consent is obtained (if applicable). The investigator is responsible for obtaining written informed assent/consent for the subject or legally acceptable representative (e.g. parent, legal guardian) after adequate explanation of the study design, anticipated benefits and the potential risks. Subjects should sign the most current REB approved assent/consent prior to any study specific activity or procedure is performed. (Sites will follow their REB board requirements for consenting).
3. Participants must have a relapsed or refractory B cell acute lymphoblastic leukemia (B-ALL).
4. Participants must have refractory or relapsed disease, defined as one of the following:
1. Relapse or refractory disease after at least 2 lines of therapy, OR
2. Any relapse after autologous or allogeneic hematopoietic cell transplantation (HCT), OR
3. Any relapse after CAR-T cell therapy.
5. 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 applicable).
6. Participants must have adequate organ function at enrolment, defined as:
1. Left ventricular ejection fraction (LVEF) ≥45%,
2. Creatinine clearance using Cockcroft-Gault or Schwartz equation of \> 30 mL/min, AND
3. ALP/ALT \< 5X upper limit of normal (ULN), conjugated bilirubin \< 2X ULN, and no evidence or history of liver cirrhosis.
7. Participants must have a Karnofsky or Lansky Score ≥50%.
8. Participants in 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.
9. Participants willingness to undergo a bone marrow biopsy at enrolment.
Exclusion Criteria:
1. Any uncontrolled or serious active infection at the time of enrolment.
2. Active autoimmune disease requiring immunosuppressive therapy within 4 weeks of enrolment.
3. Live vaccine ≤6 weeks prior to enrolment
4. Active Graft Versus Host Disease (GVHD) requiring systemic immunosuppressive therapy within 4 weeks of enrolment.
5. Treatment with any of the following in the specified time period before leukapheresis:
1. Allogeneic HCT within 3 months,
2. Autologous HCT within 3 months,
3. CD19 CAR-T cell infusion within 3 months,
4. Donor lymphocyte infusion (DLI) within 3 months,
5. Bendamustine within the last 6 months,
6. Any investigational agent within 30 days or 5 half-lives (whichever is shorter),
7. 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.
8. Immunosuppressive therapies (i.e., calcineurin inhibitors, methotrexate, mycophenolate, rapamycin) within 4 weeks.
9. 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.
6. 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.
7. 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.
8. Active (confirmed by PCR) hepatitis B or hepatitis C at time of screening confirmed by PCR.
9. Any Human Immunodeficiency Virus (HIV) infection at time of screening.
10. Hypersensitivity to fludarabine or cyclophosphamide.
11. Any allergy to gentamycin or its derivatives
12. Pregnant or nursing participants.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Study:
NCT06208735
Study Brief:
Protocol Section:
NCT06208735