OncoMatch/Clinical Trials/NCT06208735
CLIC-2201 for the Treatment of Relapsed/Refractory B Cell Malignancies
Is NCT06208735 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies CLIC-2201 for b-cell leukemia.
Treatment: CLIC-2201 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Acute Lymphoblastic Leukemia
Chronic Lymphocytic Leukemia
Non-Hodgkin Lymphoma
Diffuse Large B-Cell Lymphoma
Biomarker criteria
Required: MYC rearrangement
high grade B cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
Required: BCL2 rearrangement
high grade B cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
Required: BCL6 rearrangement
high grade B cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
Required: CD22 expression (testing required; no eligibility threshold specified)
documentation of CD22 tumour expression within the 6 months prior to study screening, and after any prior CD22 directed therapy (if applicable)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: systemic therapy
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
Lab requirements
Kidney function
Creatinine clearance using Cockcroft-Gault or Schwartz equation of > 30 mL/min
Liver function
ALP/ALT < 5X upper limit of normal (ULN), conjugated bilirubin < 2X ULN, and no evidence or history of liver cirrhosis
Cardiac function
Left ventricular ejection fraction (LVEF) ≥40% (cohort A), ≥45% (cohort B)
adequate organ function at enrolment, defined as: Left ventricular ejection fraction (LVEF) ≥40% (A), ≥45% (B); Creatinine clearance > 30 mL/min; ALP/ALT < 5X ULN, conjugated bilirubin < 2X ULN, and no evidence or history of liver cirrhosis
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06208735 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received systemic therapy.
Does this trial require MYC?
Yes, MYC rearrangement is a required biomarker for enrollment.
Does this trial require BCL2?
Yes, BCL2 rearrangement is a required biomarker for enrollment.
Does this trial require BCL6?
Yes, BCL6 rearrangement is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 39 years or younger and at least 1 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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