Actively Recruiting
Dose Escalating Study of CD19/CD22/BCMA Autologous CAR-T Cell Therapy in Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
Led by Shanghai Cell Therapy Group Co.,Ltd · Updated on 2025-08-21
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating CD19/CD22/BCMA chimeric antigen receptor T (CAR-T) cell therapy for patients with relapsed or refractory B cell non-Hodgkin lymphoma. This early phase 1, single arm, open-label study aims to assess the safety and tolerability of this treatment and determine the highest dose patients can safely receive. Additional goals include studying how the CAR-T cells behave in the body and their effect on patient survival. Participants will undergo several phases including screening, cell collection (apheresis), lymphodepletion with chemotherapy drugs cyclophosphamide and fludarabine, followed by a single intravenous infusion of the CAR-T cells. Safety and dose-limiting toxicities will be monitored from day 1 to day 28 after infusion. After this, patients will be followed for longer-term effects and outcomes until the study ends. During the study, patients will have regular evaluations including blood tests to measure CAR-T cell levels, cytokines, and drug pharmacokinetics. Survival and disease progression will be tracked for up to two years. The entire process includes careful monitoring for side effects and treatment response, with visits and assessments scheduled throughout the treatment and follow-up periods.
CONDITIONS
Brief Title
A Dose Escalating Study of CD19/CD22/BCMA CAR-T Therapy in Relapsed or Refractory B Cell Non-Hodgkin Lymphoma(NHL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with relapsed or refractory B cell non-Hodgkin lymphoma including DLBCL, PMBCL, TFL, HGBCL, or HGBCL with MYC and BCL2/BCL6 rearrangement
- Refractory disease defined as no response or stable disease to last therapy, or relapse/progression post-autologous stem cell transplant
- Prior treatment with anti-CD20 monoclonal antibody and anthracycline chemotherapy
- Immunohistochemical staining positive for at least two of CD19, CD20, BCMA
- At least one measurable lesion at screening
- Life expectancy of at least 12 weeks
- ECOG performance status 0 or 1
- Adequate kidney, liver, lung, and heart function as defined by specific laboratory and clinical measures
- Adequate bone marrow function with specified blood count thresholds
- Agree to use effective contraception until CAR-T cells are undetectable by PCR
You will not qualify if you...
- Previous anti-CD45 or anti-CD3 therapy
- Presence or history of central nervous system lymphoma, brain metastases, or CNS disorders such as seizures or stroke
- History of allogeneic stem cell transplantation
- Active hepatitis B or C infection or HIV or syphilis infection
- Uncontrolled or life-threatening infections requiring intravenous antibiotics
- Unstable angina, recent heart attack within 6 months, or severe uncontrolled diseases
- Uncontrolled heart arrhythmia
- Pregnancy or breastfeeding
- Other protocol-defined criteria may apply
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - Up to 28 days prior to apheresis
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 days prior to infusion
Participants undergo leukapheresis to collect peripheral blood cells for CAR-T cell production.
1 visit (in-person)
Duration - 3 days (Day -5 to Day -3)
Participants receive chemotherapy with cyclophosphamide and fludarabine to prepare the body for CAR-T cell infusion.
Daily visits for 3 days (in-person)
Duration - 1 day (Day 0)
Participants receive a single intravenous infusion of CD19/CD22/BCMA CAR-T cells.
1 visit (in-person)
Duration - 28 days (Day 1 to Day 28)
Participants are monitored closely for safety and tolerability of CAR-T therapy during the first 28 days after infusion.
Frequent visits during 28 days post-infusion (in-person)
Duration - From Day 29 up to study completion
Participants are followed to assess long-term safety, CAR-T cell persistence, and clinical outcomes up to the end of the study.
Visits at Day 28, Month 2, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24
Trial Site Locations
Total: 1 location
1
Mengchao Cancer Hospital
Shanghai, Shanghai Municipality, China, 201800
Actively Recruiting
Research Team
J
Jinxing Lou
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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