OncoMatch/Clinical Trials/NCT05098613
Preliminary Safety and Tolerability of CD19x22 CAR T Cells in Adolescent and Adult R/R B-NHL Patients
Is NCT05098613 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies CD19x22 CAR T Cells for non-hodgkin lymphoma.
Treatment: CD19x22 CAR T Cells — This open-label, single arm phase 1 trial aims to determine the safety and tolerability of anti-CD19 and anti-CD22 chimeric antigen receptor-expressing (CAR) T cells (CD19x22 CAR T) in adolescents and adults with relapsed/refractory (R/R) B-cell Non-Hodgkin Lymphoma (B-NHL). This trial will determine the maximum tolerated dose of CD19x22 CAR T cells using a standard 3+3 trial design.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Primary Central Nervous System Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anthracycline
The two lines of prior therapy must include an anthracycline and anti-CD20 monoclonal antibody treatment
Must have received: anti-CD20 monoclonal antibody
The two lines of prior therapy must include an anthracycline and anti-CD20 monoclonal antibody treatment
Must have received: CAR-T cell therapy
Relapse or refractory after single antigen targeting CAR T cell therapy
Lab requirements
Blood counts
ANC ≥ 500/μL; Platelet count ≥ 50,000/μL
Kidney function
Creatinine ≤ 2 mg/dL OR creatinine clearance ≥ 60 mL/min
Liver function
ALT/AST ≤ 3x ULN; total bilirubin ≤ 2 mg/dl (≤ 4.0 mg/dl for Gilbert's syndrome); for lymphodepletion: ALT/AST ≤ 3x ULN, total bilirubin ≤ 2 mg/dl (≤ 3.0 mg/dl for Gilbert's syndrome); for infusion: ALT/AST < 5x ULN
Cardiac function
Ejection fraction ≥ 40% (≥ 45% for lymphodepletion); no evidence of physiologically significant pericardial effusion; no clinically significant ECG findings within 6 weeks of apheresis
Adequate organ function as defined by: ANC ≥ 500/μL; Platelet count ≥ 50,000/ μL; Creatinine ≤ 2 mg/dL OR creatinine clearance ≥ 60 mL/min; ALT/AST ≤ 3x ULN; Total bilirubin ≤ 2 mg/dl, except in subjects with Gilbert's syndrome where a bilirubin <4.0 will be acceptable. Cardiac: Ejection fraction ≥ 40%, no evidence of physiologically significant pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings within 6 weeks of apheresis. Pulmonary: No clinically significant pleural effusion and; Baseline oxygen saturation must be > 92% on room air
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Colorado Hospital · Aurora, Colorado
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