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Trial Title:
Targeting CD19/CD20 Dual-targeted Cell in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
NCT ID:
NCT06395870
Condition:
B-Cell Non-Hodgkin Lymphoma-Recurrent
B-Cell Non-Hodgkin Lymphoma-Refractory
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
LUCAR-G39D cells product
Description:
Prior to infusion of the LUCAR-G39D, subjects will receive a conditioning premedication
regimen consisting of cyclophosphamide and fludarabine.
Arm group label:
LUCAR-G39D cells product
Summary:
A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy
of LUCAR-G39D, a dual-targeted cell preparation targeting CD19/CD20, in patients with
relapsed/refractory B-cell non-Hodgkin lymphoma.
Detailed description:
This is an open-label, dose-escalation/dose extension study to assess the safety,
tolerability, and efficacy of LUCAR-G39D in the patient ≥ 18 years of age with relapsed
or refractory B-cell non-Hodgkin lymphoma. Subjects who meet the eligibility criteria
will receive a single dose of LUCAR-G39D injection. The study will include the following
sequential phases: screening, pre-treatment (lymphodepleting chemotherapy), treatment,
and follow-up.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subjects have fully understood the possible risks and benefits of participating in
this study, are willing to follow and able to complete all trial procedures, and
have signed informed consent.
2. Aged 18-75 years (inclusive).
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Histologically confirmed B-cell non-Hodgkin Lymphoma that expresses at least one of
CD19/CD20.
5. At least one evaluable tumor lesion according to Lugano 2014 criteria.
Response to prior therapy is consistent with one of the following:
1. Primary refractory.
2. Relapsed or refractory after 2 or more lines of therapy.
3. For LBCL, 3B FL. t-iNHL:
- Relapse within 12 months after first-line chemoimmunotherapy to achieve CR;
- Progression or relapse within 12 months after autologous hematopoietic stem
cell transplantation;
7. Life expectancy≥ 3 months 8. Clinical laboratory values meet screening
visit criteria
Exclusion Criteria:
Subject eligible for this study must not meet any of the following criteria:
1. Prior antitumor therapy with insufficient washout period ; 2. Patients who
received autologous CAR-T cell therapy (except CD19-targeted) or autologous
gene therapy; 3. Patients who received allogeneic hematopoietic stem cell
transplantation or allogeneic therapy; 5. Patients who are positive for any
index of hepatitis B surface antigen (HBsAg), hepatitis B virus
deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C
virus ribonucleic acid (HCV RNA), or human immunodeficiency virus antibody
(HIV- Ab).
6. Known life-threatening allergies, hypersensitivity, or intolerance to
LUCAR-G39D CAR-T cell or its excipients, including DMSO.
7. Pregnant or lactating women;
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Oncology Department, The First Affiliated Hospital of USTC west district
Address:
City:
Hefei
Zip:
230000
Country:
China
Status:
Recruiting
Contact:
Last name:
Kaiyang Ding
Phone:
13966672170
Email:
dingkaiy@126.com
Facility:
Name:
Tianjin Cancer Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Recruiting
Contact:
Last name:
Huilai Zhang, MD
Phone:
+86-18622221228
Email:
huilaizhangtz@163.com
Start date:
May 9, 2024
Completion date:
June 30, 2028
Lead sponsor:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Collaborator:
Agency:
Nanjing Legend Biotech Co.
Agency class:
Industry
Source:
Tianjin Medical University Cancer Institute and Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06395870
