OncoMatch/Clinical Trials/NCT06213636
Fourth-gen CAR T Cells Targeting CD19/CD22 for Highly Resistant B-cell Lymphoma/Leukemia (PMBCL/CNS-BCL).
Is NCT06213636 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies CD19/CD22-CAR T cells for acute lymphoblastic leukemia, adult b-cell.
Treatment: CD19/CD22-CAR T cells — This is an open-label, single-arm, phase I clinical trial with dose escalation designed to investigate the safety, tolerability, and pharmacokinetic properties of Human CD19-CD22 Targeted T Cells Infusion. The primary objectives are to preliminarily assess the impact of Human CD19-CD22 Targeted T Cells Infusion in patients with relapsed/refractory B-cell acute lymphoblastic leukemia and to explore the appropriate dose and reinfusion schedule for phase II. Eligible participants, including those with Central Nervous System Lymphoma, B Cell Lymphoma (BCL), Acute Lymphocytic Leukemia (ALL), Acute Lymphoblastic Leukemia (ALL), B Acute Lymphoblastic Leukemia (B-ALL), Refractory Non-Hodgkin Lymphoma, Refractory Chronic Lymphocytic Leukemia (CLL), Refractory B Acute Lymphoblastic Leukemia (B-ALL), Diffuse Large B Cell Lymphoma, Lymphoid Leukemia, and MRD-positive cases, can participate. Eligibility will be determined through a comprehensive assessment, including disease evaluations, a physical examination, Electrocardiograph, Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET), and blood tests. Prior to the infusion of CD19-CD22 CAR+ T cells, participants will undergo chemotherapy. After the infusion, participants will be closely monitored for potential side effects and the effectiveness of CD19-CD22 CAR+ T cells. Certain study procedures may be conducted during hospitalization.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Diffuse Large B-Cell Lymphoma
Biomarker criteria
Required: CD19 overexpression (greater than 50% of malignant cells by IHC or ≥ 90% by flow cytometry)
CD19 expression is required at any time since diagnosis. ... must be detected on greater than 50% of the malignant cells by immunohistochemistry or ≥ 90% by flow cytometry.
Allowed: CD22 prior anti-CD22 CAR therapy allowed if < 5% of circulating CD3+ cells express previous CAR
Subjects who have undergone prior anti-CD19 or anti-CD22 CAR therapy will be eligible if < 5% of circulating levels of CD3+ cells express the previous CAR by flow cytometry.
Allowed: CD19 prior anti-CD19 CAR therapy allowed if < 5% of circulating CD3+ cells express previous CAR
Subjects who have undergone prior anti-CD19 or anti-CD22 CAR therapy will be eligible if < 5% of circulating levels of CD3+ cells express the previous CAR by flow cytometry.
Allowed: BCR::ABL1 fusion
Subjects with Philadelphia Chromosome positive acute lymphoblastic leukemia (Ph+ALL) subjects are eligible if they progressed, had stable disease or relapsed after two lines of therapy, including tyrosine kinase inhibitors (TKIs).
Prior therapy
Must have received: anthracycline — initial treatment
Subjects with lymphoma must have progressed, had SD, or recurred after initial treatment regimens that include an anthracycline and an anti CD20 monoclonal antibody.
Must have received: anti-CD20 monoclonal antibody — initial treatment
Subjects with lymphoma must have progressed, had SD, or recurred after initial treatment regimens that include an anthracycline and an anti CD20 monoclonal antibody.
Must have received: tyrosine kinase inhibitor
Subjects with Philadelphia Chromosome positive acute lymphoblastic leukemia (Ph+ALL) subjects are eligible if they progressed, had stable disease or relapsed after two lines of therapy, including tyrosine kinase inhibitors (TKIs).
Lab requirements
Blood counts
ANC ≥750/uL; Platelet count ≥50,000/uL; Absolute lymphocyte count ≥150/uL
Kidney function
creatinine: within age adjusted normal institutional limits OR creatinine clearance ≥60 mL/min/1.73 m2
Liver function
Serum ALT/AST ≤10 ULN (unless elevated ALT/AST is attributed to leukemia or lymphoma involvement of the liver, in which case this criterion will be waived and not disqualify a patient). Total bilirubin ≤1.5 mg/dl, except in subjects with Gilbert's syndrome.
Cardiac function
Cardiac ejection fraction ≥ 45%, no evidence of physiologically significant pericardial effusion as determined by an ECHO, and no clinically significant ECG findings
Normal Organ and Marrow Function (supportive care is allowed per institutional standards, i.e. filgrastim, transfusion) * ANC ≥750/uL* * Platelet count ≥50,000/uL* * Absolute lymphocyte count ≥150/uL* * Adequate renal, hepatic, pulmonary and cardiac function defined as: * Serum ALT/AST ≤10 ULN (unless elevated ALT/AST is attributed to leukemia or lymphoma involvement of the liver, in which case this criterion will be waived and not disqualify a patient). * Total bilirubin ≤1.5 mg/dl, except in subjects with Gilbert's syndrome. * Cardiac ejection fraction ≥ 45%, no evidence of physiologically significant pericardial effusion as determined by an ECHO, and no clinically significant ECG findings * No clinically significant pleural effusion * Baseline oxygen saturation >92% on room air at rest * creatinine: within age adjusted normal institutional limits (see table below) OR * creatinine clearance ≥60 mL/min/1.73 m2 (as estimated by Cockcroft Gault Equation) for subjects with creatinine levels above institutional normal.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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