Clinical Study of SL19+22 CAR-T Cells for Relapsed or Refractory Non-Hodgkin Lymphoma
Study Details
Study Description
Brief Summary
To evaluate the safety and efficacy of SL19+22 in patients with relapsed or refractory non-Hodgkin's lymphoma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
SL19+22 injection is a CAR-T product independently developed by Senlang that targets both CD19 and CD22. Based on the traditional CAR T treatment regimen, the CAR structure was designed, and the activation mode of T cells was changed by using cytokine combination amplification and improved transfection technology.
The Main research objectives:
To evaluate the safety and efficacy of SL19+22 in patients with recurrent or refractory non-Hodgkin's lymphoma
The Secondary research objectives:
To investigate the cytokinetic characteristics of SL19+22 in patients with recurrent or refractory non-Hodgkin's lymphoma.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SL 19+22 CAR-T
|
Biological: CD19+22 CAR-T cells
Biological: CD19+22 CAR-T; Drug: Cyclophosphamide,Fludarabine;
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Safety: Incidence and severity of adverse events [First month post CAR-T cells infusion]
To evaluate the possible adverse events could occurred within first month post infusion.
- Efficacy: Overall Remission Rate (ORR) [3 months post CAR-T cells infusion]
Overall Remission Rate (ORR) including partial remission and complete remission rate after infusion of SL19+22
Secondary Outcome Measures
- Efficacy:duration of response (DOR) [24 months post CAR-T cells infusion]
duration of response (DOR)
- Efficacy: progression-free survival (PFS) [24 months post CAR-T cells infusion]
progression-free survival (PFS) time
- CAR-T proliferation [3 months post CAR-T cells infusion]
the copy number of CD19 and CD22 CAR- T cells in the genomes of PBMC by qPCR
- Cytokine release [First month post CAR-T cells infusion]
Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry
Eligibility Criteria
Criteria
Inclusion Criteria:
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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;
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The diagnosis of patients with relapsed or refractory non-hodgkin lymphoma;
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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;
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There should be at least one measurable tumor foci according to the RECIST version 1.1;
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ECOG Scores: 0~2;
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The expression of CD19 and/or CD22 on the tumor cells are reported as positive by either immunohistochemistry or flow cytometry;
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Estimated survival time is longer than 3 months;
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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%；
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Peripheral blood mononuclear immune cells must be collected at least 2 weeks after the last radiotherapy or systemic treatment.
Exclusion Criteria:
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Serious cardiac insufficiency；
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Has a history of severe pulmonary function damaging;
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Coexisting with severe or persistent infection that cannot be effectively controlled;
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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;
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Presence of metabolic diseases (except diabetes and Dyslipidemia);
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Presence of severe autoimmune diseases or immunodeficiency disease;
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Patients with active hepatitis B or hepatitis C virus infection;
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Patients with HIV infection or syphilis infection;
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Has a history of serious allergies on Biological products (including antibiotics);
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Participated in any other clinical drug trial for the last three months(except clinicaltrials of CART );
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Being pregnant, lactating, or planing on pregnancy in the next 12 months.
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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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hebei Yanda Ludaopei Hospital | Langfang | Hebei | China | 065000 |
Sponsors and Collaborators
- Hebei Senlang Biotechnology Inc., Ltd.
Investigators
- Principal Investigator: Peihua Lu, PhD&M, Hebei Yanda Ludaopei Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SL19+22 for NHL