Clinical trial · Interventional
CAR19 Donor Lymphocytes for Relapsed CD19+ Malignancies Following Allogeneic Transplantation
Chimeric Antigen Receptor (CAR)19 Donor Lymphocytes for Relapsed Cluster of Differentiation (CD)19+ Malignancies Following Allogeneic Transplantation (CARD)
NCT02893189CI-TRIAL-00067412CARDcompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Eligible patients will receive escalating doses of 4G7-CARD T-cells paralleling clinical standard of care with unmanipulated donor lymphocytes. There are 3 intra-patient dose levels planned. Patients will be followed up regularly during the interventional phase of the study until 12 months post-final 4G7-CARD T-cell infusion. Thereafter patients will be followed up annually for years 2 and 3.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CD19+ Malignancies: Relapse Post-allogeneic Transplant | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Infusion of modified CAR19 T-cells (4G7-CARD T-cells) | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 4G7-CARD T-cells
- description
- All patient will receive modified CAR19 T-cells.
- interventionNames
- Genetic: Infusion of modified CAR19 T-cells (4G7-CARD T-cells)
Primary outcomes (2)
- measure
- Feasibility of generation of 4G7-CARD T-cells using the ProdigyTM system
- timeFrame
- Through patient registration and manufacturing period, an average of 18 months from start of trial
- description
- The number of ATIMP successfully manufactured would be assessed for all registered patients
- measure
- Maximum grade for each toxicity type as assessed by CTCAE v4.03, summarized as proportions.
- timeFrame
- Up to 3 years post final 4G7-CARD T-cell infusion
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 16-70 years 2. Confirmed diagnosis of CD19+ malignancy relapsing following allogeneic transplantation 3. Agreement to have a pregnancy test, use adequate contraception for 12 months post-final 4G7-CARD T-cell infusion 4. Karnofsky performance status \>60 5. Written informed consent Exclusion Criteria: 1. Women who are pregnant or lactating 2. Prior history of ischaemic heart disease, dysrhythmias, abnormal ECG (LBBB), Multi Gated Acquisition Scan (MUGA) left ventricular ejection fraction (LVEF\<40%) (if performed) 3. Known involvement of the central nervous system or cerebral vascular accident within prior 3 months 4. Patients receiving corticosteroids at a dose of \> 10mg prednisolone per day (or equivalent) 5. Active graft versus host disease requiring immunosuppression 6. Use of rituximab within the last 2 months prior to ATIMP infusion 7. Known allergy to albumin or dimethyl sulfoxide (DMSO) 8. Patients who have experienced significant neurotoxicity following blinatumomab treatment
References
Publications (3)
- DERIVEDKrawczyk M, Druzynska M, Bednarska E, Winiarska M. The race between 4-1BB- and CD28-based CD19 CAR-T products in the therapy of B-cell malignancies. Biochim Biophys Acta Rev Cancer. 2026 Feb;1881(1):189519. doi: 10.1016/j.bbcan.2025.189519. Epub 2025 Dec 20. PMID 41429239
- DERIVEDRoddie C, Dias J, O'Reilly MA, Abbasian M, Cadinanos-Garai A, Vispute K, Bosshard-Carter L, Mitsikakou M, Charalambous E, Mehra V, Roddy H, Cheung GW, Hartley JA, Mahmoud N, Ensell L, Patel Y, Marzolini MAV, Farzaneh F, Nickolay L, Himoudi N, Syed F, Popova B, Galani S, Day A, Lowdell MW, Peggs KS. Matched donor allogeneic CAR-T for adult B-ALL: toxicity, efficacy, repeat dosing, and the importance of lymphodepletion. Blood. 2025 Oct 2;146(14):1664-1676. doi: 10.1182/blood.2025028790. PMID 40643148
- DERIVEDO'Reilly M, Roddie C, Marzolini MAV, Rodriguez-Justo M, Pomplun S, Pule M, Peggs KS. Trafficking of CAR T cells to sites of subclinical leukaemia cutis. Lancet Oncol. 2020 Mar;21(3):e179. doi: 10.1016/S1470-2045(19)30861-7. No abstract available. PMID 32135121