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Recruiting Phase 1

Targeting CD19/CD20 Dual-targeted Cell in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

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About this study

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.

Condition
B-Cell Non-Hodgkin Lymphoma-Recurrent, B-Cell Non-Hodgkin Lymphoma-Refractory
Tested
LUCAR-G39D cells product
Sponsor
Tianjin Medical University Cancer Institute and Hospital

Who can join

Age
18 to 75 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 15

  • Minimum age: 18 years
  • Maximum age: 75 years
  • Study condition: B-Cell Non-Hodgkin Lymphoma-Recurrent, B-Cell Non-Hodgkin Lymphoma-Refractory
  • 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.
  • Aged 18-75 years (inclusive).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Histologically confirmed B-cell non-Hodgkin Lymphoma that expresses at least one of CD19/CD20.
  • At least one evaluable tumor lesion according to Lugano 2014 criteria.
  • Response to prior therapy is consistent with one of the following:
  • Primary refractory.
  • Relapsed or refractory after 2 or more lines of therapy.
  • 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;
  • \. Life expectancy≥ 3 months 8. Clinical laboratory values meet screening visit criteria

Exclusion 7

  • Subject eligible for this study must not meet any of the following criteria:
  • 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).
  • \. Known life-threatening allergies, hypersensitivity, or intolerance to LUCAR-G39D CAR-T cell or its excipients, including DMSO.
  • \. Pregnant or lactating women;

Where

2 sites, 2 recruiting

Oncology Department, The First Affiliated Hospital of USTC west district

Hefei, Anhui, China

Recruiting

Tianjin Cancer Hospital

Tianjin, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.