NCT06120166 Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of r/r DLBCL Clinical Research
| NCT ID | NCT06120166 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | He Huang |
| Condition | Diffuse Large B-cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2023-11-16 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 18 participants in total. It began in 2023-11-16 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory Diffuse Large B-Cell Lymphoma
Eligibility Criteria
Inclusion Criteria: * The patient or his/her guardian voluntarily signed the informed consent * Adult Patients clinical diagnosis of relapsed and refractory diffuse large B-cell lymphoma (Primary mediastinal large B-cell lymphoma and transformed follicular lymphoma are included) Definition of refractory: 1. No response to the last treatment, including: The best response to the last treatment was PD, or ; The best response to the last treatment was SD and the duration was not more than 6 months after the last dose. 2. Not suitable for autologous hematopoietic stem cell transplantation (ASCT), or ASCT refractory, including: Disease progression or recurrence within 12 months or less (recurrence must be confirmed by biopsy) after ASCT treatment, or; Patients accept remedial treatment after ASCT must have no response or relapse after the last treatment * Patients who had previously received ≥2 lines therapy including at least: 1. A chemotherapy regimen containing anthracyclines 2. For patients with transformed DLBCL from follicular lymphoma, they must have previously received chemotherapy for follicular lymphoma and have refractory disease after transformation to DLBCL. * Patients with double-strike and triple-strike lymphoma who do not respond to second-line treatment, where double-strike/triple-strike is defined as: Detection of lymphoma cells with C-MYC gene translocation accompanied by BCL-2 gene translocation or/and BCL-6 gene translocation by chromosome or FISH technology. * CD19 expression was positive by immunohistochemistry or flow cytometry (accept the results of this peripheral blood mononuclear cells or previous report from a Class A tertiary hospital before peripheral blood collection) * At least one measurable lesion at baseline, according to the initial assessment, staging and Response Assessment recommendations for Hodgkin's and non-Hodgkin's lymphoma (2014 edition) * Expected survival time greater than 12 weeks * The baseline ECOG score was 0 or 1 * Organ function: 1. Kidney function is defined as: Serum creatinine ≤1.5 times ULN, or; The glomerular filtration rate (eGFR) estimated by MDRD formula was ≥60m/ min/1.73m2; \[eGFR=186×(age)-0.203×SCr- 1. 154(mg/dl), for females, the result was ×0.742\] 2. Liver function is defined as: ALT≤5 times ULN, and; Patients with total bilirubin ≤2.0mg/dl, except those with Gilbert-Meulengracht syndrome. Patients with Gilbert-Meulengracht syndrome with total bilirubin ≤3.0 times ULN and direct bilirubin ≤1.5 times ULN were included 3. Pulmonary function: ≤CTCAE grade 1 dyspnea and oxygen saturation of blood (SaO2) ≥91% in indoor air environment. * Hemodynamic stability was determined by echocardiography or multichannel radionuclide angiography (MUGA) and LVEF ≥45% * Patients using the following drugs must meet the following conditions: 1. Steroid: Therapeutic doses of steroids must be discontinued 2 weeks prior to Meta10-19 infusion. However, physiological replacement doses of steroids are permitted, hydrocortisone or its equivalent \<6-12mg/mm2/ day 2. Immunosuppressive agent: Any immunosuppressive drug must be stopped ≥4 weeks before the informed consent is signed 3. Anti-proliferative therapy in addition to preconditioning chemotherapy 2 weeks prior to Meta10-19 infusion 4. Treatment for CNS disease must be stopped 1 week before Meta10- 19 infusion (e.g., intrathecal methotrexate) * The patient has recovered from the toxicity of the previous treatment, that is, the CTCAE toxicity grade is less than 1 (The exception is specific toxicity of grade 2 or less, such as hair loss, which the researchers have determined is not recoverable in a short period of time) is suitable for pretreatment chemotherapy and CAR T cell therapy * Women of childbearing age and all male patients must consent to use a effective contraception for at least 12 months after Meta10-19 infusion and until two consecutive PCR tests show no more CAR T cells in vivo Exclusion Criteria: * Patients with present or history of central nervous system diseases such as seizures disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement * Patients with history of allogeneic hematopoietic stem cell transplantation * Patients who had received chemotherapy other than preconditioning chemotherapy within 2 weeks prior to Meta10-19 infusion * Patients who participated in other clinical trials within 30 days prior to enrollment * Patients with active hepatitis B (defined as hepatitis B surface antigen positive or hepatitis B core antibody positive, concomitant hepatitis B virus DNA level \>1000 copies/ml) or hepatitis C (HCV RNA positive) * Patients with HIV antibody positive or treponema pallidum antibody positive * Patients with uncontrolled acute life-threatening bacterial, viral or fungal infections (e.g. positive blood cultures ≤72 hours before Meta10-19infusion) * Patients with unstable angina pectoris and/or myocardial infarction within 6 months prior to enrollment * Patients with history of other malignancies, but the following conditions can be enrollment: 1. Adequately treated basal or squamous cell carcinoma (requiring adequate wound healing before signing informed consent); 2. Carcinoma in situ (DCIS) of cervical or breast cancer, which has been treated therapeutically, has shown no signs of recurrence for at least 3 years prior to the signing of the informed consent 3. The primary malignancy has been completely resected and in complete remission for ≥5 years * Women who are pregnant or breastfeeding (pregnancy tests for women of childbearing age are positive) * Patients with active neuroautoimmune or inflammatory conditions (e.g. Guillian-Barre syndrome, amyotrophic lateral sclerosis); * Other conditions that the investigator considered should not be enrolled in this clinical study, such as poor compliance.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06120166 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diffuse Large B-cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06120166 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06120166 currently recruiting?
Yes, NCT06120166 is actively recruiting participants. Contact the research team at mingmingzhang@zju.edu.cn for enrollment information.
Where is the NCT06120166 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06120166 clinical trial?
NCT06120166 is sponsored by He Huang. The trial plans to enroll 18 participants.