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

NCT07775508 | Recruiting Phase 1 DMC

• 1 other identifier: 2026-174
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This 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).

Conditions

B-cell Lymphoma

Keywords

in vivo CAR-T; CD19; CD20; SL1617; lentiviral vector; immunotherapy; B-cell lymphoma

Outcome Measures

Primary Outcomes (2)

• Incidence and Severity of Adverse Events

  The number, percentage, and severity of adverse events (AEs) following SL1617 Injection infusion, including cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), hematologic toxicity, organ toxicity, and other immune therapy-related toxicities, graded per CTCAE v6.0.

  From SL1617 infusion through 24 months after treatment

• Incidence of Dose-Limiting Toxicities (DLTs)

  The number and percentage of participants who experience DLTs during the protocol-defined DLT observation period (Days 1-28) following a single intravenous infusion of SL1617 Injection.

  During the protocol-defined DLT observation period after SL1617 infusion

Secondary Outcomes (6)

• Objective Response Rate at Prespecified Follow-up Time Points

  At 1, 3, 6, 9, 12, 18, and 24 months after SL1617 infusion

• Complete Response Rate

  At 1, 3, 6, 9, 12, 18, and 24 months after SL1617 infusion

• Partial Response Rate

  At 1, 3, 6, 9, 12, 18, and 24 months after SL1617 infusion

• Overall Survival

  From SL1617 infusion through 24 months after treatment

• Progression-Free Survival

  From SL1617 infusion through 24 months after treatment

Study Arms (1)

SL1617 Treatment

EXPERIMENTAL

Drug: SL1617 Injection

Interventions

SL1617 Injection DRUG

Participants with relapsed or refractory B-cell lymphoma will receive SL1617 Injection, an investigational in vivo CD19/CD20-targeted CAR T-cell immunotherapy, by intravenous infusion according to the protocol. Participants will subsequently undergo safety and efficacy assessments for up to 24 months after treatment.

SL1617 Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. The subject voluntarily agrees to participate in the study, has signed the informed consent form, and is willing and able to comply with the scheduled visits, study treatment, laboratory tests, and other study procedures.
• \. Patients with B-cell lymphoma confirmed by cytological or histopathological examination according to the 2022 World Health Organization classification, meeting all of the following criteria:
• Lymphoma cells are confirmed to express CD19 and/or CD20 antigens by immunophenotyping or immunohistochemical examination.
• Eligible B-cell lymphomas include:
• Aggressive B-cell lymphomas, including large B-cell lymphoma (LBCL), Burkitt lymphoma (BL), and mantle cell lymphoma (MCL);
• Indolent B-cell lymphomas, including chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), follicular lymphoma (FL), marginal zone lymphoma (MZL), lymphoplasmacytic lymphoma (LPL), and hairy cell leukemia (HCL).
• Relapsed or refractory B-cell lymphoma, defined as follows:
• Relapse: The patient has received adequate prior therapy and previously achieved a complete response (CR) or partial response (PR) after first-line systemic therapy (which must include an anti-CD20 monoclonal antibody and an anthracycline-containing chemotherapy regimen), second-line or subsequent systemic therapy, or autologous hematopoietic stem cell transplantation (ASCT), but relapsed after the completion of treatment, with disease progression confirmed by cytology or histology;
• Refractory: The patient failed to achieve CR or PR after first-line systemic therapy, or had no response to the most recent second-line or subsequent systemic therapy regimen, with progressive disease (PD) or stable disease (SD) as a best response of treatment.
• The patient must have at least one measurable lesion. If salvage therapy was administered after ASCT, the patient must have no response to the most recent salvage therapy or must have relapsed after the most recent salvage therapy. Patients with relapsed indolent lymphoma may be enrolled only if clinical indications for treatment are present, such as symptomatic mass lesions, organ compression, cytopenias, or B symptoms.
• \. Male or female subjects aged 18-75 years, inclusive. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 5. Estimated life expectancy of more than 3 months from the date of signing the informed consent form.
• \. Absolute neutrophil count≥1×10\^9/L, platelet count≥75×10\^9/L, hemoglobin≥60g/L.
• \. 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;

You may not qualify if:

• \. The patient has severe cardiac dysfunction, or left ventricular ejection fraction (LVEF) \<50%, or a history within the 12 months prior to enrollment of myocardial infarction, coronary angioplasty or coronary stent implantation, unstable angina, clinically significant arrhythmia, or other severe cardiovascular diseases.
• \. A history of severe pulmonary dysfunction or severe pulmonary disease associated with impaired lung function.
• \. The patient has a history of malignancies other than B-cell lymphoma, and is ineligible unless they have been disease-free and have not received any form of antineoplastic therapy for at least 3 consecutive years.
• \. Severe active infection that cannot be effectively controlled. 5. The patient has severe autoimmune disease, congenital immunodeficiency or active autoimmune disease requiring ongoing treatment, or is currently within the washout period after having received medications that may affect CAR-T cell immunotherapy, or is anticipated to require medications during the study period that may affect CAR-T cell immunotherapy treatment.
• \. The patient has tuberculosis infection, active hepatitis B virus (HBV) infection, active hepatitis C virus (HCV) infection, or human immunodeficiency virus (HIV) infection; has received a live vaccine within 4 weeks, or is anticipated to require a live vaccine during the study period.
• \. The patient has previously undergone allogeneic hematopoietic stem cell transplantation, solid organ allogeneic transplantation, or allogeneic cell therapy.
• \. A history of severe allergic reactions to biological products, including antibiotics.
• \. The patient has other significant uncontrolled comorbidities that may affect protocol compliance or interpretation of results.
• \. The investigator judges that the patient is unlikely to complete all visits and procedures required by the study protocol (including medium- and long-term follow-up visits), such as insufficient willingness of the patient and their family members to participate in the study, refusal to participate, inability of the patient to fully cooperate with the study arrangements, or inadequate compliance on the part of the patient and their family members.
• \. Any other severe physical or psychiatric disorder or clinically significant laboratory abnormality that may increase the risk associated with study participation, interfere with the interpretation of study results, or, in the investigator's judgment, make the patient unsuitable for participation in the study.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• Hebei Senlang Biotechnology Inc., Ltd.: collaborator

Study Sites (1)

Chinese PLA General Hospital, Beijing, Beijing 100853

Beijing, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Li-Ping Dou, Dr.

CONTACT

86-010-66937232; lipingruirui@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Professor, and Director of the Department of Hematology

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 20, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): January 1, 2029
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)