OncoMatch/Clinical Trials/NCT06879340
Evaluating the Safety and Efficacy of DuoCAR20.19.22-D95 in Adult Patients With Relapsed or Refractory B-cell Malignancies
Is NCT06879340 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including DuoCAR20.19.22-D95 and Fludarabine (Conditional therapy) for b-cell non-hodgkin lymphoma.
Treatment: DuoCAR20.19.22-D95 · Fludarabine (Conditional therapy) · Cyclophosphamide (Conditional therapy) — This multicenter phase 1 trial with "3 + 3" dose escalation design seeks to examine the feasibility and safety of the administration of autologous T cells that have been modified through the introduction of chimeric antigen receptors targeting the B cell surface antigens CD19/20/22 following administration of a chemotherapy lymphodepletion regimen in adults with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) or Non-Hodgkin's lymphoma (NHL). The overall goals of this study are to estimate maximum tolerated dose (MTD) level, establish the overall safety profile and evaluate initial efficacy of administering duo-CAR-T cell treatment in this patient population.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD19 expression (demonstration of one or more antigens of interest (CD19, CD20, CD22) in most recent disease evaluation)
Demonstration of one or more antigens of interest (CD19, CD20, CD22) in most recent disease evaluation prior to study entry and within 30 days of study entry
Required: CD20 expression (demonstration of one or more antigens of interest (CD19, CD20, CD22) in most recent disease evaluation)
Demonstration of one or more antigens of interest (CD19, CD20, CD22) in most recent disease evaluation prior to study entry and within 30 days of study entry
Required: CD22 expression (demonstration of one or more antigens of interest (CD19, CD20, CD22) in most recent disease evaluation)
Demonstration of one or more antigens of interest (CD19, CD20, CD22) in most recent disease evaluation prior to study entry and within 30 days of study entry
Required: CCND1 overexpression
mantle-cell lymphoma with either cyclin D1 overexpression or presence of the translocation (T11:14)
Required: CCND1 translocation (T11:14)
mantle-cell lymphoma with either cyclin D1 overexpression or presence of the translocation (T11:14)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anti-CD20 monoclonal antibody
anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20- negative
Must have received: anthracycline
an anthracycline containing chemotherapy regimen
Must have received: alkylating agent
an alkylating agent
Must have received: BTK inhibitor
BTK inhibitor therapy
Must have received: CAR-T cell therapy
Prior CAR T therapy permissible if ≥ 3 months from the therapy
Lab requirements
Blood counts
Patients with established diagnosis of benign neutropenia are eligible to participate with ANC between 1000-1500 if in the opinion of treating physician the trial treatment does not pose excessive risk of infection to the patient.
Kidney function
Liver function
Adequate hematologic and organ function NOTE: Patients with established diagnosis of benign neutropenia are eligible to participate with ANC between 1000-1500 if in the opinion of treating physician the trial treatment does not pose excessive risk of infection to the patient.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Kansas Cancer Center · Westwood, Kansas
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