C-CAR066 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (r/r B-NHL)

• Status: Not yet recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this multicenter study is to test C-CAR066 in Relapsed or Refractory Non-Hodgkin Lymphoma Patients. The main questions the study aims to answer are:

• is C-CAR066 safe and do patients tolerate it well?

• what is the best dose of C-CAR066?

• will C-CAR066 help patients achieve a response and for how long?

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cellular Biomedicine Group, Inc.
• Collaborator: Mayo Clinic

Criteria

Key Inclusion Criteria

Patients will be eligible for the study only if all the following criteria apply:

• Written informed consent must be obtained prior to any screening procedures

• ≥ 18 years of age, at the time of signing informed consent

• Diagnosis of aggressive B cell non-Hodgkin lymphoma

• Histologically confirmed CD20 positive disease by immunohistochemistry test result and corresponding pathology report

• Relapsed or refractory disease after ≥ 2 lines of standard therapy (i.e., no response or progression/relapse after first- and second-line therapy) and having relapsed within 12 months of receipt of the most recent anti-lymphoma treatment

• Measurable disease as defined in the IRB approved clinical protocol

• ECOG performance status of either 0 or 1 at screening

• Adequate organ function as defined in the IRB approved clinical protocol

• Life expectancy ≥ 12 weeks

• Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) and all male participants must agree to use highly effective methods of contraception for one year following C-CAR066 CAR-T therapy

• Sexually active males who accept to use a condom during intercourse drug for 12 months after treatment. A condom is also required by vasectomized men (as well as during intercourse with a male partner) to prevent delivery of the drug via seminal fluid

Key Exclusion Criteria

Patients will be excluded from the study if any of the following criteria apply:

• Human herpes virus (HHV) 8-positive Diffuse large B Cell lymphoma(DLBCL)

• Prior allogeneic Hematopoietic stem cell transplantation (HSCT)

• Autologous stem cell transplant within 12 weeks of CAR T cell infusion

• The exclusion of following medications: Steroids, Immunosuppressive therapy, Chemotherapy, Antibody, Investigational medicinal products and CNS disease prophylaxis

• Received a live vaccine within 4 weeks of leukapheresis

• Uncontrolled active infections as defined in the IRB approved clinical protocol

• History of deep vein thrombosis or pulmonary embolism within six months of infusion (line associated deep vein thrombosis (DVT) is allowed)

• History of stroke, unstable angina, myocardial infarction, congestive heart failure (NYHA Class III or IV), severe cardiomyopathy or ventricular arrhythmia requiring medication or mechanical control within 6 months of screening

• History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease

• Known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system

• Active central nervous system (CNS) involvement by malignancy

• Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease per Investigator assessment)

• Previous or concurrent malignancy as defined in the IRB approved clinical protocol

• Women of child-bearing potential who are pregnant or breastfeeding

• Severe allergies to fludarabine or cyclophosphamide

• Any known allergies to the components or excipients of the C-CAR066 cell product

• History or current evidence of any condition, therapy, or laboratory abnormality that, in the opinion of the investigator, might confound the results of the trial, interfere with the patient's safe participation and compliance in the trial