NCT07319676 Antigen Targeted T Cell Therapy for Relapsed/Refractory B Cell Lymphomas
| NCT ID | NCT07319676 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | National University Hospital, Singapore |
| Condition | B-cell Lymphoma Refractory |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-03-02 |
| Primary Completion | 2028-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2026-03-02 with a primary completion date of 2028-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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)
Contact & Investigator
Michelle Poon
PRINCIPAL INVESTIGATOR
NUHS
Frequently Asked Questions
Who can join the NCT07319676 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 80 Years, studying B-cell Lymphoma Refractory. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07319676 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07319676 currently recruiting?
Yes, NCT07319676 is actively recruiting participants. Contact the research team at michelle_poon@nuhs.edu.sg for enrollment information.
Where is the NCT07319676 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT07319676 clinical trial?
NCT07319676 is sponsored by National University Hospital, Singapore. The principal investigator is Michelle Poon at NUHS. The trial plans to enroll 30 participants.