B Cell Lymphoma, CD30+ Peripheral T-cell Lymphoma, Lymphoma
Conditions
Keywords
CD30 CAR-T, lymphoma
Brief summary
The is a prospective, open-label, dose-climbing multicenter 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 efficacy and safety of CD30 CAR-T on CD30 positive relapsed/refractory lymphoma. The main questions it aims to answer are: To evaluate the safety and maximum tolerated dose 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
Tongji Hospital Affiliated to Tongji Medical College of HUST
Shanxi Bethune Hospital
Wuhan Central Hospital
Yichang Central People's Hospital
First Affiliated Hospital of Guangxi Medical University
Shandong Qilu Cell Therapy Engineering Technology Co., Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age≥18 years and ≤65years，female and male； * CD30+ recurrent/refractory malignant hematological malignancies, experienced recurrence (disease progression after treatment remission) or refractory (previous systemic treatment did not achieve CR) after ≥ 2-line systemic treatment; * CD30 expression \>10% by immunohistochemistry； * At least 1 measurable lesion can be measured according to theLugano 2014 evaluation criteria; * 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 |
|---|---|---|
| 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 |
|---|---|---|
| Overall response rate | 3,6,12months | Including complete remission (CR) and partial remission (PR) |
| Overall Survival | 3 years | OS was calculated from the first CAR-T cell infusion to death or last follow-up |
| Progression-free survival | 3 years | PFS was calculated from the first CAR-T cell infusion to death or rogression of the disease. |
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 ContactLU Qi
Outcome results
None listed