Status:
UNKNOWN
Clinical Study of SL19+22 CAR-T Cells for Relapsed or Refractory Non-Hodgkin Lymphoma
Lead Sponsor:
Hebei Senlang Biotechnology Inc., Ltd.
Conditions:
Non-hodgkin's Lymphoma
Eligibility:
All Genders
3-75 years
Phase:
NA
Brief Summary
To evaluate the safety and efficacy of SL19+22 in patients with relapsed or refractory non-Hodgkin's lymphoma.
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 activ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05206071
Start Date
May 1 2021
End Date
December 31 2023
Last Update
January 25 2022
Active Locations (1)
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1
Hebei Yanda Ludaopei Hospital
Langfang, Hebei, China, 065000