Lymphoma, B-Cell
Conditions
Keywords
CD30 CAR-T; lymphoma;
Brief summary
The is a prospective, open-label, dose-climbing clinical study assessing the efficacy and safety of CD30 CAR-T in the treatment of r/r CD30+ lymphoma. Plan to recruit 15 subjects with r/r CD30+ lymphoma。
Detailed description
The goal of this clinical trial is to explore the effect of CD30 CAR-T on CD30 positive relapsed/refractory lymphoma. The main questions it aims to answer are: To evaluate the safety of autologous CD30 CAR-T therapy in CD30-positive relapsed/refractory lymphoma; To evaluate the efficacy of autologous CD30 CAR-T therapy for CD30-positive relapsed/refractory lymphoma; To evaluate the metabolism of CD30 CAR-T cells in vivo; Preliminary evaluation of the correlation between CAR T cell dose and clinical efficacy.
Interventions
The rate of intravenous infusion of CD30 CAR T cells was 10 mL to 20 mL/min, and the infusion was performed using a blood transfusion apparatus with a filter screen. Use saline rinsing tube prior to infusion; Rinse the infusion bag with 10 mL\ 30 mL normal saline.
Sponsors
Shanxi Bethune Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age≥15 years and ≤80years，female and male； * CD30+ lymphocyte malignancies; * CD30 expression \>10% by immunohistochemistry； * At least 1 measurable lesion can be measured according to theLugano 2014 evaluation criteria; * Not suitable for autologous hematopoietic stem cell transplantation or recurrence after autologous hematopoietic stem cell transplantation; * Not suitable for BV treatment or relapse after BV treatment, and the expression of CD30 was confirmed by histology; * The estimated survival time ≥3 months; * ECOG performance status 0-2，KPS\>60%; * Sufficient organ function：ALT，AST≤2.5×ULN，patients with liver invasion can be relaxed to ≤ 5 x ULN；serum total bilirubin\<34 μmol/L；creatinine clearance rate\>30 mL/min；EF≥40%；No pericardial effusion and obvious arrhythmia；SpO2≥92%； * ALC ≥0.5×109/L，PLT\>30×109/L，Hb\>80 g/L and subjects had apheresis venous access and no contraindications for blood cell separation; * MRI showed no central involvement of lymphoma; * Patients with fertility must be willing to be able to use reliable contraceptive measures ; * The subject or legal guardian can understand and voluntarily sign the written informed consent.
Exclusion criteria
* Lymphoma-associated hemophagic cell syndrome; * Pregnant or lactating women, and women who have a pregnancy plan within six months; * Hepatitis B（HBsAg、HBsAb、HBeAg、HBeAb、HBcAb），Hepatitis C（Anti-HCV），Anti-HIV Ⅰ/Ⅱ and anti-TP positive（Hepatitis B DNA test is negative except）; * Suffered from other malignant tumors, except for for skin basal cell carcinoma, skin squamous cell carcinoma and cervical carcinoma in situ undergoing the radical treatment; * Received Anti-CD30 Ab therapy within 4 weeks before enrollment; * Unresolved \> Grade 1 non-hematologic toxicity associated with any prior treatments; * Active uncontrolled bleeding or a known bleeding diathesis; * Autologous hematopoietic stem cell transplantation was performed within 6 weeks; * Uncontrollable active bacterial or fungal infection； * Known allergy to the study drug and its components; * Suffer from active autoimmune diseases that require systemic treatment ; * Persons with mental or mental illness who cannot cooperate with treatment and efficacy evaluation; * Participated in other clinical studies within 1 months prior to this study; * History of allogeneic hematopoietic stem cell transplantation; * patients with any condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate | 6 months | Including complete remission (CR) and partial remission (PR) |
| To evaluate safety and dose limiting toxicities (DLT) of autologous CD30 CAR-T and establish the recommended Phase dose | 28 days | Incidence of DLTs and occurrence of study related adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival | 3years | DFS was calculated from the first CAR-T cell infusion to death, progression of the disease, relapse or gene recurrence, whichever came first, or last visit. |
| Overall Survival | 3 years | OS was calculated from the first CAR-T cell infusion to death or last follow-up |
Other
| Measure | Time frame | Description |
|---|---|---|
| The copy number of CD30 CAR-T cells | 12 months | The copy number of CD30 CAR-T cells amplified in peripheral blood after administration |
Countries
China
Contacts
Primary Contactjia wei
Outcome results
None listed