Current concepts in the diagnosis and management of cytokine release syndrome.
Daniel W Lee, Rebecca Gardner, David L Porter...
https://pubmed.ncbi.nlm.nih.gov/24876563Actively Recruiting
Phase 1
Phase 2
Age: 10Years - 80Years
All Genders
ID07319676
Antigen Targeted T Cell Therapy for Relapsed/Refractory B Cell Lymphomas
Led by National University Hospital, Singapore · Updated on 2026-04-09
30
Participants Needed
1
Research Sites
626 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new T cell therapy for patients with high risk or relapsed/refractory B cell lymphoma, a type of blood cancer. This phase 1 and 2 trial aims to determine the recommended dose and assess the safety and effectiveness of CAR T-cells targeting CD19 and sometimes CD22 antigens on lymphoma cells. The study also explores how adding Epo-R to the CAR T-cells may help the cells survive and expand better in patients previously treated with chemotherapy. The study includes several parts: screening, cell collection and preparation, lymphodepletion before infusion, and the CAR T-cell infusion itself. Patients undergo leukapheresis to collect T cells, which are modified and expanded in the lab based on their tumor's antigen profile. The first 3-6 patients will participate in a safety run-in to determine the best dose, followed by a phase 2 portion where 20 patients receive the treatment at the recommended dose. Monitoring includes frequent blood tests and PET-CT scans to evaluate response. Participants will be closely followed through scheduled visits on days 0, 7, 14, 21, 28, then monthly up to 6 months, and yearly thereafter for up to 15 years. Assessments include imaging to check disease status and blood tests to measure CAR T-cell levels. Safety monitoring focuses on potential side effects like cytokine release syndrome and neurological symptoms. Long-term follow-up helps understand the treatment's lasting effects and patient outcomes.
CONDITIONS
Brief Title
Antigen Targeted T Cell Therapy for Relapsed/Refractory B Cell Lymphomas
Who Can Participate
Age: 10Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 10 to 80 years at screening
- Measurable disease on PET-CT scan by Lugano classification (Deauville score 64)
- Tissue biopsy of any tumor site with flow cytometry study of CD19 and CD22 expression
- Relapsed B-cell lymphoma after one line of systemic therapy or autologous bone marrow transplant, including DLBCL, PMBCL, HGBCL, DLBCL from indolent lymphoma, Burkitt's lymphoma/leukemia, Mantle cell lymphoma
- High risk B-cell lymphoma defined by high-risk genetics, IPI score 63, Richter's transformation, or disease refractory to treatment
- Peripheral blood mononuclear cell product available
- Karnofsky or Lansky score above 70, or ECOG 0-2
- Expected survival more than 3 months to allow CAR T-cell manufacture and release
You will not qualify if you...
- Pregnant or lactating women or positive pregnancy test
- Refusal to use birth control methods if sexually active and able to conceive
- Genetic syndromes linked to bone marrow failure except Down syndrome
- Active hepatitis B or C within 3 months before screening
- Active HIV infection within 3 months before screening
- Grade 2 to 4 graft-versus-host disease
- Received investigational drug within 1 month before screening
- Sum of CD19 and CD22 antigen expression less than 95%, unless rescreened
- Uncontrolled seizures, status epilepticus, or decreased consciousness
- Foreign patients unable to stay in Singapore for at least 3 months post-infusion and long-term monitoring
- Prior treatment with any CAR T-cell therapy, approved or investigational
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single infusion with follow-up assessments up to 6 months
Participants receive infusion of autologous CAR T-cells targeting CD19 with or without CD22 to treat their B cell lymphoma. The CAR T-cells are manufactured from the participant’s own T cells collected before infusion.
Visits on Day 0, Day 5, Day 7, Day 14, Day 21, and monthly up to 6 months
Follow-up
Duration - Up to 2 years
Participants are monitored for safety, disease response, and CAR T-cell levels in blood up to 2 years after infusion.
Visits at 1 month, 3 months, 6 months, 1 year, and 2 years post-infusion
Trial Site Locations
Total: 1 location
1
National University Hospital
Singapore, Singapore, Singapore, 119228
Actively Recruiting
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Research Team
M
Michelle Poon
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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Daniel W Lee, Bianca D Santomasso, Frederick L Locke...
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Christian Gisselbrecht, Bertram Glass, Nicolas Mounier...
https://pubmed.ncbi.nlm.nih.gov/20660832Crump M, Neelapu SS, Farooq U, et al. Outcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 study. Blood. 2017;130(16):1800-1808.
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Frederick L Locke, Armin Ghobadi, Caron A Jacobson...
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Andreas Viardot, Marie-Elisabeth Goebeler, Georg Hess...
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Robert Stirrups
https://pubmed.ncbi.nlm.nih.gov/32278358