Clinical Study of SL19+22 CAR-T Cells for Relapsed or Refractory Non-Hodgkin Lymphoma

NCT05206071 | Unknown

• 1 other identifier: SL19+22 for NHL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and efficacy of SL19+22 in patients with relapsed or refractory non-Hodgkin's lymphoma.

Conditions

Non-hodgkin's Lymphoma

Keywords

NHL，19+22

Outcome Measures

Primary Outcomes (2)

• Safety: Incidence and severity of adverse events

  To evaluate the possible adverse events could occurred within first month post infusion.

  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 SL19+22

  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)

SL 19+22 CAR-T

EXPERIMENTAL

Biological: CD19+22 CAR-T cells

Interventions

CD19+22 CAR-T cells BIOLOGICAL

Biological: CD19+22 CAR-T; Drug: Cyclophosphamide,Fludarabine;

Also known as: CD19+22 CAR-T

SL 19+22 CAR-T

Eligibility Criteria

• Age: 3 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign the informed consent form and be 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;
• The definition of recurrent or refractory non-Hodgkin lymphoma: Patients with DLBCL, pmbcl and TFL diagnosed by histopathology are resistant to standard treatment; Or PD after at least second-line standard treatment; Or the last treatment effect was SD and the duration was no longer than 6 months; Or CD20 positive patients were ineffective or relapsed after anti-CD20 monoclonal antibody treatment; Or PD after autologous hematopoietic stem cell transplantation or recurrence confirmed by biopsy within 12 months; Or patients undergoing salvage treatment after autologous hematopoietic stem cell transplantation had no remission or recurrence after end-line treatment;
• There should be at least one measurable tumor foci according to the RECIST version 1.1;
• ECOG Scores: 0\~2;
• The expression of CD19 and/or CD22 on the tumor cells are reported as positive by either immunohistochemistry or flow cytometry;
• Estimated survival time is longer than 3 months;
• Main organ functions shall meet the following requirements: 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;
• Coexisting with severe or persistent infection that cannot be effectively controlled;
• Patients with a history of other malignancies, except those with non-melanoma skin cancer or carcinoma in situ (eg, cervical cancer, bladder cancer, breast cancer) who have received curative treatment at least 2 years prior to screening without disease recurrence;
• Presence of metabolic diseases (except diabetes and Dyslipidemia);
• Presence of 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 three months(except clinicaltrials of CART );
• Being pregnant, lactating, or planing on pregnancy in the next 12 months.
• Any situations that the researchers believe will increase the risks for the subject or affect the results of the study(have a history of serious mental illness, drug abuse and addiction).

Sponsors & Collaborators

• Hebei Senlang Biotechnology Inc., Ltd.: lead

Study Sites (1)

Hebei Yanda Ludaopei Hospital

Langfang, Hebei, 065000, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Peihua Lu, PhD&M

  Hebei Yanda Ludaopei Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peihua Lu, PhD&M

CONTACT

008618611636172; peihua_lu@126.com

Jianqiang Li, PhD&M

CONTACT

008615511369555; limmune@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: January 11, 2022
• First Posted: January 25, 2022
• Study Start: May 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 25, 2022

Record last verified: 2022-01

Locations

CN (1)