Clinical Trial of SL1904B CAR-T Cells for Relapsed or Refractory Non-Hodgkin Lymphoma

STATUS

Recruiting
participants needed

20
sponsor

Hebei Senlang Biotechnology Inc., Ltd.

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Updated on 19 February 2024

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platelet count

absolute neutrophil count

neutrophil count

treatment regimen

ejection fraction

lymphoma

hodgkin's disease

flow cytometry

immunohistochemistry

oxygen saturation

non-hodgkin's lymphoma refractory

refractory non-hodgkin's lymphoma

non-hodgkin lymphoma

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.

Description

The CARs consist of an anti-CD19 single-chain variable fragmentscFv that was derived from the FMC63 mouse hybridoma, a portion of the human CD1374-1BB molecule, and the intracellular component of the human CD3 molecule. Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy.

The Main research objectives:

To evaluate the safety and efficacy of SL1904B in patients with recurrent or refractory non-Hodgkin's lymphoma

The Secondary research objectives:

To investigate the cytokinetic characteristics of SL1904B in patients with recurrent or refractory non-Hodgkin's lymphoma.

Details

Condition	Lymphoma, Lymphoma
Age	3years - 70years
Treatment	CD19 CAR-T
Clinical Study Identifier	NCT04447547
Sponsor	Hebei Senlang Biotechnology Inc., Ltd.
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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 50109/L; absolute Neutrophil count (ANC) 1.0109/L; Blood oxygen saturation >92%
	Peripheral blood mononuclear immune cells must be collected at least 2 weeks after the last radiotherapy or systemic treatment
Exclusion Criteria
	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

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Clinical Trial of SL1904B CAR-T Cells for Relapsed or Refractory Non-Hodgkin Lymphoma