Antigen-targeted CAR T therapy for relapsed or high-risk B-cell lymphoma
Antigen Targeted T Cell Therapy for Relapsed/Refractory B Cell Lymphomas
This research will test a personalized CAR T-cell treatment that targets CD19, and sometimes CD22, in people with relapsed or high‑risk B‑cell lymphoma.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 10 Years to 80 Years |
| Sex | All |
| Sponsor | National University Hospital, Singapore Academic / other |
| Drugs / interventions | rituximab, CAR T, CART, CAR-T |
| Locations | 1 site (Singapore, Singapore) |
| Trial ID | NCT07319676 on ClinicalTrials.gov |
What this trial studies
This single-center, open-label Phase 1 lead-in followed by a Phase 2 trial will determine the recommended Phase 2 dose and then test safety and efficacy of Epo-R–CD19 CAR T-cells with or without CD22 CAR T-cells in patients with relapsed or high‑risk B‑cell lymphoma. Eligible patients undergo leukapheresis and tumor antigen profiling, and CAR T products are manufactured based on CD19/CD22 expression. Patients receive lymphodepleting chemotherapy before infusion and are admitted for close monitoring for cytokine release syndrome and neurotoxicity. Primary endpoints include dose-limiting toxicities and RP2D in Phase 1, and response by PET-CT (Lugano criteria) plus CAR T expansion metrics and survival outcomes in Phase 2, with long-term follow-up.
Who should consider this trial
Good fit: Ideal candidates are people aged 10–80 with PET‑CT measurable relapsed or high‑risk B‑cell lymphoma who can provide tumor tissue for antigen profiling and undergo leukapheresis.
Not a fit: Patients without measurable CD19 or CD22 on their tumor, with very limited life expectancy that precludes product manufacture, or who cannot tolerate leukapheresis or lymphodepletion are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could increase response rates and make remissions more durable by improving CAR T-cell expansion and persistence in patients with relapsed or high‑risk B‑cell lymphoma.
How similar studies have performed: CD19-targeted CAR T therapies have produced strong responses in relapsed B‑cell lymphomas, while pooled CD19/CD22 targeting and the Epo‑R co-expression approach are more novel and less proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Age 10 to 80 years at screening * PET-CT measurable disease by Lugano classification (Deauville score of ≥4) and * Tissue biopsy of any tumour 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. This includes DLBCL, PMBCL, HGBCL, DLBCL arising from indolent lymphoma, Burkitt's lymphoma/leukemia, Mantle cell lymphoma. * High risk B-cell lymphoma (BCL). High risk BCL is defined by any of the criteria below: * High-risk genetics - double/triple hit or p53mut or deletion. * IPI score ≥ 3 * Richter's transformation from chronic lymphocytic leukaemia. * Disease refractory to treatment - PET-CT positive disease after 2 courses of rituximab-containing chemoimmunotherapy. * PBMC product available * Karnofsky or Lansky score \>70. Or ECOG 0-2 * Patient expected survival is more than 3 months to allow for manufacture and release of CAR T-cells. Exclusion Criteria * Patients who test positive on urine or blood pregnancy testing and are pregnant or are lactating. * Participant of reproducible age who refuse the use of the following birth control methods if engaging in sexual activity that could lead to pregnancy. The methods include condoms, diaphragm, intrauterine device, hormonal based contraception. * Concomitant genetic syndromes associated with BM failure states, such as Fanconi anaemia, Kostmann syndrome, Schwachman syndrome, or any other BM failure syndrome with the exception of Down syndrome. * Active hepatitis B or hepatitis C within 3 months of screening. * Active HIV infection within 3 months of screening. * Grade 2 to 4 graft-vs-host disease (GVHD). * Received an investigational medicinal product within 1 month of screening. * If the total sum of CD19 and CD22 antigens expressed is less than 95.0%, patients will not be eligible. If subsequent immunophenotying of the patient's sample confirms that total sum of CD19 and CD22 antigens ≥ 95%, the patient may be rescreened. * Central nervous system: Uncontrolled seizures or status epilepticus; decreased conscious state (any cause) * Foreign patients who cannot commit to agreeable to stay in Singapore for at least 3 months post CAR T infusion and are committed to the long term monitoring post CAR T at home and in Singapore. * Prior treatment with any CAR T cell therapy (approved or investigational)
Where this trial is running
Singapore, Singapore
- National University Hospital — Singapore, Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Michelle Poon — Nuhs
- Study coordinator: Michelle Poon
- Email: michelle_poon@nuhs.edu.sg
- Phone: 67724394
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.