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NCT07319676
Antigen Targeted T Cell Therapy for Relapsed/Refractory B Cell Lymphomas
Phase 1, PHASE2 trial testing CART infusion in B-cell Lymphoma Refractory in 30 participants. Currently enrolling.
31 October 2028
Quick facts
| Lead sponsor | National University Hospital, Singapore |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 2 March 2026 |
| Primary completion | 31 October 2028 |
| Estimated completion | 31 October 2040 |
| Sites | 1 location across Singapore |
Drugs / interventions tested
- CART infusion — full drug profile →
Conditions studied
- B-cell Lymphoma Refractory — all drugs for B-cell Lymphoma Refractory →
Sponsor
National University Hospital, Singapore
Who can join
Adults 10 to 80, any sex, with B-cell Lymphoma Refractory. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07319676
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Related trials
Other recruiting trials for B-cell Lymphoma Refractory
Currently open trials in the same condition.
- NCT07321301 — Polymer-lipid Particle-delivered CAR1920 mRNA CAR-T Therapy for Relapsed/Refractory B-cell Lymphoma/Leukemia · Phase 2 · recruiting
- NCT06552559 — Selinexor With ICE Chemotherapy in Secondary Central Nervous System Involving B-cell Non-Hodgkin Lymphoma · Phase 1, PHASE2 · recruiting
- NCT05705570 — Clinical Trial Using CAR- T Cells for Treatment of Patients With Refractory or Relapsed CD19-positive B Lymphoid Maligna · Phase 1 · recruiting
- NCT06220097 — Mitoxantrone Hydrochloride Liposome Injection-containing Bridging Regimen and CD19-targeting CAR-T Therapies · Phase 2 · active not recruiting
- NCT04214886 — CD19 Chimeric Antigen Receptor (CAR) T Cells for Adults With Recurrent or Refractory B Cell Malignancies · Phase 1 · active not recruiting
Other National University Hospital, Singapore trials
Trials by the same sponsor.
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- NCT07091175 — Dupilumab Therapy in Nephrotic Syndrome in Children · Phase 2 · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07319676 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National University Hospital, Singapore
- Last refreshed: 9 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07319676.
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