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OncoMatch/Clinical Trials/NCT06532643

Safety and Efficacy of Anti-CD20/CD30 CAR-T Cells in Subjects with Relapsed/Refractory Lymphoma

Is NCT06532643 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments including Fludarabine and Cyclophosphamide for relapsed/refractory lymphoma.

Early Phase 1RecruitingShanghai First Song Biotechnology Co., LTDNCT06532643Data as of May 2026

Treatment: Fludarabine · CyclophosphamideThis study is an exploratory clinical trial of a single-center, open-label, single-dose treatment of anti-CD20/CD30-CAR-T cells in subjects with relapsed/refractory lymphoma.

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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Biomarker criteria

Required: CD20 positive expression

CD20/CD30 double-positive expressing lymphoma

Required: CD30 positive expression

CD20/CD30 double-positive expressing lymphoma

Required: CD20 positive expression

Relapse after receiving anti-CD19-CAR-T cell therapy, with CD20 positive lymphoma

Required: CD20 positive expression

CD20 positive lymphoma that has not previously received anti-CD19-CAR-T cell therapy

Required: CD30 positive expression

CD30 positive Hodgkin lymphoma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: systemic therapy — relapsed/refractory after standard treatments (including allogeneic or autologous hematopoietic stem cell transplantation)

Subjects with refractory or relapsed disease after current standard treatments (including allogeneic or autologous hematopoietic stem cell transplantation) who are not suitable for other treatment options, such as a second stem cell transplant.

Lab requirements

Blood counts

Absolute neutrophil count ≥ 1.0×10^9/L; Hemoglobin ≥ 60 g/L (no transfusion in last 7 days); Platelets ≥ 50×10^9/L (unrestricted for CLL indications).

Kidney function

Creatinine < 1.5× ULN and estimated creatinine clearance ≥ 60 mL/min.

Liver function

Total bilirubin ≤ 1.5× ULN; or ≤ 3× ULN when tumor invades liver. AST/ALT ≤ 2.5× ULN, or ≤ 5× ULN when tumor invades liver.

Cardiac function

Ejection fraction ≥ 45%, ECHO confirming no pericardial effusion (excluding small/physiological), ECG with no clinical significance.

Laboratory tests during screening must meet the following requirements... Ejection fraction ≥ 45%, with echocardiogram (ECHO) confirming no pericardial effusion (excluding small or physiological amounts), and electrocardiogram results with no clinical significance.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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