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

ConditionB-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChinese PLA General Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. 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.

Lymphoma cells are confirmed to express CD19 and/or CD20 antigens by immunophenotyping or immunohistochemical examination.

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).

Disqualifiers

1. 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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: SL1617 TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From SL1617 infusion through 24 months after treatment
2

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.

Time frame
During the protocol-defined DLT observation period after SL1617 infusion

Secondary outcomes

1

Objective Response Rate at Prespecified Follow-up Time Points

The objective response rate (ORR) at 1, 3, 6, 9, 12, 18, and 24 months after treatment, defined as the proportion of participants who achieve a complete response (CR) or partial response (PR).

Time frame
At 1, 3, 6, 9, 12, 18, and 24 months after SL1617 infusion
2

Complete Response Rate

The proportion of participants who achieve a complete response at each prespecified assessment time point.

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

Partial Response Rate

The proportion of participants who achieve a partial response at each prespecified assessment time point.

Time frame
At 1, 3, 6, 9, 12, 18, and 24 months after SL1617 infusion
4

Overall Survival

Overall survival (OS), defined as the time from SL1617 infusion to death from any cause. Participants who are alive at the last follow-up will be censored on the date of their last known survival status.

Time frame
From SL1617 infusion through 24 months after treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese PLA General Hospital

Lead sponsor

Hebei Senlang Biotechnology Inc., Ltd.

Collaborator

Source ClinicalTrials.gov
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