Actively Recruiting
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
765 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single center, open label, phase 1 lead in to determine Recommended Phase 2 Dose (RP2D), followed by a phase 2 trial to evaluate the safety and efficacy of Epo-R-CD19 CAR T with or without CD22 CAR T-cells infused into patients with B cell lymphoma. The study will have the following parts: * Screening * Pre-infusion (cell product preparation and bridging) and infusion (lymphodepletion) * Primary efficacy endpoints * Long term follow up Patients who have high risk B cell lymphoma or relapsed/refractory B cell lymphoma who fufil the trial inclusion and exclusion criteria will undergo leukapheresis following trial enrollment. CAR T-cell products will then be manufactured according to the antigen expression on the patient's biopsied tumor cells. These cells will then undergo stringent testing before the patient undergoes lymphodepletion followed by CART infusion. These patients will be admitted for the infusion and closely monitored for any CRS or ICANS. This study will have a Phase 1 safety run in for the first 3-6 patients who receive the Epo-R-CD19 CAR T (with or without epoetin (erythropoietin)) to determine the tolerability and safety of this product. For the first 3-6 patients, if there are any DLT seen by Day 28, a data safety monitoring committee will be convened to assess the trial. Staggered dosing will be implemented for the first 2 participants in every dose level (DL1, DL2 and DL-1). For Phase 2, the RP2D will depend on DLT. If there is no DLT at DL+1 and DL+2, then the investigators will proceed with DL+2 as the RP2D dose. On the other hand, if there is DLT despite DL-1, then the study will be redesigned. Phase 2 will continue until a total of 20 patients received their CAR T-cell infusions. CAR-T monitoring will be performed at Day 0, 7, 14, 21, 28, month 2, 3, 4, 5, 6, 12 and yearly thereafter. The total duration of the study is 15 years from CAR T infusion.
CONDITIONS
Official Title
Antigen Targeted T Cell Therapy for Relapsed/Refractory B Cell Lymphomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 10 to 80 years at screening
- PET-CT measurable disease by Lugano classification (Deauville score of 64)
- Tissue biopsy of any tumor site and 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 (double/triple hit, p53 mutation or deletion), IPI score 63, Richter's transformation from chronic lymphocytic leukemia, or refractory disease after 2 courses of rituximab-containing chemoimmunotherapy
- Peripheral blood mononuclear cell (PBMC) product available
- Karnofsky or Lansky score >70 or ECOG performance status 0-2
- Expected survival more than 3 months to allow manufacture and release of CAR T-cells
You will not qualify if you...
- Positive urine or blood pregnancy test, pregnant or lactating
- Refusal to use birth control methods if sexually active that could lead to pregnancy
- Genetic syndromes causing bone marrow failure (e.g., Fanconi anemia, Kostmann syndrome, Schwachman syndrome), except Down syndrome
- Active hepatitis B or C within 3 months of screening
- Active HIV infection within 3 months of screening
- Grade 2 to 4 graft-versus-host disease
- Receipt of investigational medicinal product within 1 month of screening
- Combined CD19 and CD22 antigen expression less than 95% unless rescreened with confirmed 65 95%
- Uncontrolled seizures or status epilepticus; decreased level of 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
Trial Site Locations
Total: 1 location
1
National University Hospital
Singapore, Singapore, Singapore, 119228
Actively Recruiting
Research Team
M
Michelle Poon
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here