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Trial Title:
Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of r/r DLBCL Clinical Research
NCT ID:
NCT05715606
Condition:
Diffuse Large B-cell Lymphoma
Conditions: Official terms:
Lymphoma, Large B-Cell, Diffuse
Conditions: Keywords:
Meta10-19
CAR-T Cells Therapy
r/r DLBCL
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Metabolically Armed CD19 CAR-T cells
Description:
Each subject receive metabolically armed CD19 CAR-T cells by intravenous infusion
Arm group label:
Administration of Metabolically Armed CD19 CAR-T cells
Other name:
Meta10-19
Summary:
A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Relapsed and/or
Refractory Diffuse Large B-Cell Lymphoma
Detailed description:
This is a single arm, open-label study. This study is indicated for relapsed or
refractory CD19+ Diffuse Large B-Cell Lymphoma. The selections of dose levels and the
number of subjects are based on clinical trials of similar foreign products.
1. Main research objectives:
To evaluate the safety and efficacy of metabolically armed CD19 CAR-T Cells in the
treatment of r/r DLBCL.
2. Secondary research objectives:
（1）To evaluate the pharmacokinetic (PK) and pharmacodynamics(PD) characteristics of
metabolically armed CD19 CAR-T Cells after infusion.
（2）To evaluate tumor remission after infusion of metabolically armed CD19 CAR-T Cells.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. The patient or his/her guardian voluntarily signed the informed consent;
2. Adult Patients with 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.
3. 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.
4. 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)
5. 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)
6. Expected survival time greater than 12 weeks
7. The baseline ECOG score was 0 or 1
8. 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.
9. Hemodynamic stability was determined by echocardiography or multichannel
radionuclide angiography (MUGA) and LVEF ≥45％
10. 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)
11. 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
12. 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:
1. 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
2. Patients with history of allogeneic hematopoietic stem cell transplantation
3. Patients who had received chemotherapy other than preconditioning chemotherapy
within 2 weeks prior to Meta10-19 infusion
4. Patients who participated in other clinical trials within 30 days prior to
enrollment
5. 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)
6. Patients with HIV antibody positive or treponema pallidum antibody positive
7. Patients with uncontrolled acute life-threatening bacterial, viral or fungal
infections (e.g. positive blood cultures ≤72 hours before Meta10-19 infusion)
8. Patients with unstable angina pectoris and/or myocardial infarction within 6 months
prior to enrollment
9. 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；
10. Women who are pregnant or breastfeeding (pregnancy tests for women of childbearing
age are positive)
11. Patients with active neuroautoimmune or inflammatory conditions (e.g. Guillian-Barre
syndrome, amyotrophic lateral sclerosis);
12. Other conditions that the investigator considered should not be enrolled in this
clinical study, such as poor compliance.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Anhui Provincial Hospital
Address:
City:
Hefei
Country:
China
Status:
Recruiting
Contact:
Last name:
Xingbing Wang, PhD
Phone:
+8613856007984
Email:
wangxingbing@ustc.edu.cn
Investigator:
Last name:
Xingbing Wang, PhD
Email:
Principal Investigator
Start date:
February 10, 2023
Completion date:
May 15, 2025
Lead sponsor:
Agency:
Anhui Provincial Hospital
Agency class:
Other
Collaborator:
Agency:
Leman Biotech Co., Ltd
Agency class:
Other
Source:
Anhui Provincial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05715606
