NCT04447547

Brief Summary

This is a study of patients with relapsed or refractory non-Hodgkin's lymphoma. To evaluate the safety and efficacy of SL1904B in patients with relapsed or refractory non-Hodgkin's lymphoma.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 25, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

June 30, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

September 29, 2020

Status Verified

August 1, 2020

Enrollment Period

2.2 years

First QC Date

June 22, 2020

Last Update Submit

September 25, 2020

Conditions

Non-hodgkin's Lymphoma

Keywords

NHL，CD19

Outcome Measures

Primary Outcomes (2)

  • Safety: Incidence and severity of adverse events

    To evaluate the possible adverse events occurred within first one month after SL1904B infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity

    First month post CAR-T cells infusion

  • Efficacy: Overall Remission Rate (ORR)

    Overall Remission Rate (ORR) including partial remission and complete remission rate after infusion of SL1904B

    3 months post CAR-T cells infusion

Secondary Outcomes (4)

  • Efficacy:duration of response (DOR)

    24 months post CAR-T cells infusion

  • Efficacy: progression-free survival (PFS)

    24 months post CAR-T cells infusion

  • CAR-T proliferation

    3 months post CAR-T cells infusion

  • Cytokine release

    First month post CAR-T cells infusion

Study Arms (1)

SL1904B CAR-T

EXPERIMENTAL

Patients will be treated with CD19 CAR-T cells

Biological: CD19 CAR-T

Interventions

CD19 CAR-TBIOLOGICAL

Biological: CD19 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis;

SL1904B CAR-T

Eligibility Criteria

Age3 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Sign the informed consent form and be willing and able to comply with the visit, treatment regimen, laboratory examination and other requirements of the study as stipulated in the trial flow chart;
  • The diagnosis of patients with relapsed or refractory non-hodgkin lymphoma;
  • There should be at least one measurable tumor focus according to the RECIST version 1.1;
  • ECOG Scores: 0\~2;
  • The expression of CD19 on the tumor cells was reported as positive by either immunohistochemistry or flow cytometry;
  • Estimated survival time was longer than 3 months;
  • main organ functions shall meet the following requirements including: serum creatinine ≤1.5 times the upper limit of normal value (ULN); ALT ULN 2.5 or less; AST ULN 2.5 or less; Total bilirubin ≤ 1.5ULN; Left ventricular ejection fraction (LVEF) ≥45%; Hemoglobin ≥90g/L; Platelet count ≥50×109/L; absolute Neutrophil count (ANC) ≥1.0×109/L; Blood oxygen saturation \>92%；
  • Peripheral blood mononuclear immune cells must be collected at least 2 weeks after the last radiotherapy or systemic treatment.

You may not qualify if:

  • Serious cardiac insufficiency；
  • Has a history of severe pulmonary function damaging;
  • With other tumors which is/are in advanced malignant and has/have systemic metastasis;
  • Merging the metabolic diseases (except diabetes);
  • Merging severe autoimmune diseases or immunodeficiency disease;
  • Patients with active hepatitis B or hepatitis C virus infection;
  • Patients with HIV infection or syphilis infection;
  • Has a history of serious allergies on Biological products (including antibiotics);
  • Participated in any other clinical drug trial for the last six months;
  • Being pregnant and lactating or having pregnancy within 12 months;
  • With other uncontrolled diseases and considered not suitable to participate by the researchers;
  • Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

BeiJing Ludaopei Hospital

Beijing, Yizhuang, 100000, China

RECRUITING

He bei Yan da Lu dao pei Hospital

Yanda, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Peihua Lu, PhD&MD

    Beijing Lu Daopei Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peihua Lu, PhD&MD

CONTACT

008618611636172peihua_lu@126.com

Jianqiang Li, PhD&MD

CONTACT

008615511369555limmune@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2020

First Posted

June 25, 2020

Study Start

June 30, 2020

Primary Completion

August 30, 2022

Study Completion

December 30, 2022

Last Updated

September 29, 2020

Record last verified: 2020-08

Locations

CN(2)