OncoMatch/Clinical Trials/NCT06208735
CLIC-2201 for the Treatment of Relapsed/Refractory B Cell Malignancies
Is NCT06208735 recruiting? Yes, currently enrolling (May 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
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic 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 (documented expression within 6 months prior to screening and after any prior CD22 directed therapy (if applicable))
must have 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/KARNOFSKY/LANSKY 0–2
ECOG performance status of ≤ 2 or Karnofsky Score ≥50% (Cohort A); Karnofsky or Lansky Score ≥50% (Cohort B)
Prior therapy
Must have received:
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
Cannot have received: allogeneic hematopoietic cell transplantation
Allogeneic HCT within 3 months
Cannot have received: autologous hematopoietic cell transplantation
Autologous HCT within 3 months
Cannot have received: CAR-T cell therapy (CD19 CAR-T cell infusion)
CD19 CAR-T cell infusion within 3 months
Cannot have received: donor lymphocyte infusion
Donor lymphocyte infusion (DLI) within 3 months
Cannot have received: alkylating agent (bendamustine)
Bendamustine within the last 6 months
Cannot have received: investigational agent
Any investigational agent within 30 days or 5 half-lives (whichever is shorter)
Cannot have received: corticosteroid
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
Cannot have received: immunosuppressive therapy (calcineurin inhibitors, methotrexate, mycophenolate, rapamycin)
Immunosuppressive therapies (i.e., calcineurin inhibitors, methotrexate, mycophenolate, rapamycin) within 4 weeks
Cannot have received: oral chemotherapy (venetoclax)
Exception: BTK inhibitors like ibrutinib can be continued in participants with mantle cell lymphoma throughout the trial period
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
Lab requirements
Kidney function
Creatinine clearance using Cockcroft-Gault (Cohort A) or Schwartz equation (Cohort B) > 30 mL/min
Liver function
ALP/ALT < 5X 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)
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.
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