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Immunobridging/Maintenance Therapy Versus Non-bridging Therapy in CAR-T Therapy for Low-risk R/R B-NHL

ConditionsB-NHLCART Therapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital

About this trial

This study aims to explore whether adding immunotherapy bridging treatment for low-risk refractory/relapsed B-NHL can demonstrate better outcomes, in order to find the most effective treatment plan for low-risk patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 or older, regardless of gender.

Histologically confirmed B-cell non-Hodgkin lymphoma, according to Lugano diagnostic criteria.

At least first-line treatment for relapsed or refractory patients, including chemotherapy regimens containing anthracyclines and anti-CD20 monoclonal antibody therapy; patients must meet definitions of refractory and recurrent.

No prior CD19 CAR T cell therapy.

Disqualifiers

History of allogeneic hematopoietic stem cell transplantation.

History of epilepsy, cerebrovascular ischemia/bleeding, dementia, cerebellar disease, or any autoimmune disease involving the central nervous system.

Any other malignancies within the past 2 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors (Ta, Tis, and T1).

Severe cardiovascular disease: NYHA grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias; NYHA grade III to IV heart failure or left ventricular ejection fraction (LVEF) < 50%.

Trial design

Design model

Parallel

Treatments tested in this trial

  • zanubrutinib

    Drug

    zanubrutinib 160 mg BID orally

  • CAR-T

    Drug

    CAR-T Cell therapy

  • Bridging radiotherapy

    Radiation

    For patients in the experimental group, the decision regarding radiotherapy will depend on whether the specific lesions are suitable.

  • Tislelizumab

    Drug

    200mg IV Q3-4W

Treatment groups

144 Participants
are divided into 2 treatment groups
Group A: Immunotherapy bridging treatmentExperimental treatment 4 interventions
Group B: no bridging treatmentActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Complete response rate(CRR) at 3-month

Complete response rate at 3-month is defined as the incidence of subjects achieving complete response (CR) at 3-month after CAR-T infusion according to the Lugano Classification, as determined by study investigators.

Time frame
3 months post CAR-T infusion

Secondary outcomes

1

Complete response rate(CRR) on D28

CRR on D28 after infusion is defined as the incidence of subjects achieving complete response (CR) on day 28 after CAR-T infusion according to the Lugano Classification, as determined by study investigators.

Time frame
28 days post CAR-T infusion
2

Objective remission rate (ORR) on D28

Objective remission rate (ORR) on D28 is defined as the incidence of either a CR or a partial response (PR) on day 28 after CAR-T infusion per the Lugano Classification as determined by study investigators.

Time frame
28 days post CAR-T infusion
3

Objective remission rate (ORR) at 3-month

Objective remission rate (ORR) at 3-month is defined as the incidence of either a CR or a partial response (PR) at 3-month after CAR-T infusion per the Lugano Classification as determined by study investigators.

Time frame
3 months post CAR-T infusion
4

Progression-Free Survival (PFS)

PFS is defined as the time from the CAR-T infusion date to the date of disease progression or death from any cause.

Time frame
2 years post CAR-T infusion

Other outcomes

Sponsors and contacts

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

Ruijin Hospital

Lead sponsor

Source ClinicalTrials.gov
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