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OncoMatch/Clinical Trials/NCT07775508

In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed/Refractory B-Cell Lymphoma

Is NCT07775508 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies SL1617 for b-cell lymphoma.

Phase 1RecruitingChinese PLA General HospitalNCT07775508Data as of Sep 2026Location: China

Treatment: SL1617This Phase 1, open-label, single-arm, dose-escalation study is designed to evaluate the safety and tolerability of SL1617 Injection in patients with relapsed or refractory B-cell lymphoma. SL1617 is an investigational in vivo CAR T-cell immunotherapy targeting CD19 and CD20, utilizing an engineered lentiviral vector to generate functional CAR-T cells in vivo without the need for ex vivo cell processing or lymphodepletion. Participants will receive a single intravenous infusion of SL1617 using a traditional 3+3 dose-escalation design. The planned starting dose is 1.0 × 10\^9 transducing units (TU), followed by dose levels of 3.0 × 10\^9 TU and 6.0 × 10\^9 TU. Dose escalation will be guided by the occurrence of dose-limiting toxicities (DLTs).

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Extracted eligibility criteria

Treatments studied

Other

SL1617

Cancer type

Non-Hodgkin Lymphoma

Biomarker criteria

Required: CD19 expression

Required: CD20 expression

Performance status

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

Demographics

Ages ≤ 75

Prior therapy

Min 1 prior line

Must have received: systemic therapy (anti-CD20 monoclonal antibody, anthracycline-containing chemotherapy) — first-line

first-line systemic therapy (which must include an anti-CD20 monoclonal antibody and an anthracycline-containing chemotherapy regimen)

Cannot have received: allogeneic hematopoietic stem cell transplantation

previously undergone allogeneic hematopoietic stem cell transplantation

Cannot have received: solid organ allogeneic transplantation

previously undergone solid organ allogeneic transplantation

Cannot have received: allogeneic cell therapy

previously undergone allogeneic cell therapy

Lab requirements

Blood counts

Absolute neutrophil count ≥1×10^9/L, platelet count ≥75×10^9/L, hemoglobin ≥60g/L

Kidney function

Creatinine clearance ≥60 mL/min

Liver function

ALT and AST ≤2.5×ULN, total bilirubin ≤1.5×ULN

Cardiac function

Ejection fraction ≥50%, no pericardial effusion on echocardiography, no significant ECG abnormalities

Adequate renal, hepatic, cardiac, and pulmonary function, defined as follows: Creatinine clearance (estimated by the Cockcroft-Gault formula) ≥60 mL/min; Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5×upper limit of normal (ULN), total bilirubin≤1.5×ULN; Cardiac ejection fraction≥50%, no pericardial effusion on echocardiography, and no significant abnormalities on electrocardiogram (ECG); No clinically significant pleural effusion, and oxygen saturation >92% on room air at baseline.

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

Frequently asked questions

Is NCT07775508 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior allogeneic hematopoietic stem cell transplantation, solid organ allogeneic transplantation, allogeneic cell therapy disqualifies patients from enrollment.

Does this trial require CD19?

Yes, CD19 expression is a required biomarker for enrollment.

Does this trial require CD20?

Yes, CD20 expression is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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