Clinical trial • Phase II • Oncology|Haematology

DDCART‐CD19 for Acute lymphocytic leukaemia (recurrent)

Phase II trial of DDCART‐CD19 for Acute lymphocytic leukaemia (recurrent). 8 participants.

Overview

Phase II trial across 3 sites in Greece.

Recruits 8 paediatric patients.

Vulnerable Population: Includes vulnerable population: minors (study population age range 6 months to 39 years). Assent/consent handling: Lansky performance status referenced for subjects <16 at time of assent/consent and Karnofsky for subjects ≥16 at time of assent/consent. Separate subject information / informed consent forms exist for ages 10-13 years, 14-17 years, adults, and parents (documents listed with _GR indicating Greek language).

{"criterion_text":"- Individuals between 6 months and 39 years of age who have recurrent or persistent CD19 (+) acute leukemia after allogeneic HSCT or following autologous CAR-T cell therapy"}
{"criterion_text":"- ≥5 X 10-4 CD19+ blast cells in bone marrow as determined per flow cytometry, or isolated extramedullary relapse."}
{"criterion_text":"- No evidence of ≥ grade II aGVHD or chronic GVHD while off of systemic immunosuppressive therapy for at least 4 weeks."}
{"criterion_text":"- Lansky (age < 16 years at the time of assent/consent) or Karnofsky (age ≥ 16 years at time of assent/consent) performance status ≥ 50"}
{"criterion_text":"- Availability of the initial stem cell donor."}

{"criterion_text":"- Active severe infection"}
{"criterion_text":"- Active aGVHD Grade ≥II"}
{"criterion_text":"- <30% expression of CD19 on the leukemic population"}
{"criterion_text":"- Presence of a CD19-negative leukemic subclone"}
{"criterion_text":"- Moderate/severe chronic GVHD (NIH consensus) requiring systemic steroids"}
{"criterion_text":"- Eligible for therapy with recipient-derived CAR-T cells"}

{"endpoint_text":"- Proportion of patients entered into complete remission (CR) within 30 days after DDCART-CD19 infusion.","definition_or_measurement_approach":"CR within 30 days after DDCART-CD19 infusion (timepoint specified)."}
{"endpoint_text":"- DDCART-CD19 product purity and Transduction Efficiency","definition_or_measurement_approach":"Assessment of DDCART-CD19 product purity and transduction efficiency (product characteristics; specific assay not detailed in the record)."}
{"endpoint_text":"- Proportion of patients maintain CR after 6 months, 1 year and 2 year after DDCAR-CD19 T-cell infusion","definition_or_measurement_approach":"Proportion of patients in CR at 6 months, 12 months and 24 months post-infusion (timepoints specified)."}

{"endpoint_text":"- Duration of DDCART cell detection in patients' blood","definition_or_measurement_approach":"Duration of in vivo detection/persistence of DDCART-CD19 cells in patient blood; secondary objectives note use of flow cytometry for evaluation of persistence."}
{"endpoint_text":"- Duration of B-cell aplasia","definition_or_measurement_approach":"Duration of B-cell aplasia measured post infusion (measurement method not further specified in record)."}
{"endpoint_text":"- Correlation of DDCART cell and B-cells detection with disease relapse","definition_or_measurement_approach":"Correlation analysis between persistence/detection of DDCART cells and B-cell levels with subsequent disease relapse (methodology not specified)."}

Planned Sample Size: 8
Recruitment Window Months: 60
Consent Approach: Informed consent/assent: assent and consent referenced (Lansky scale for age <16 at assent/consent; Karnofsky for age ≥16 at assent/consent). Subject information and informed consent forms available for ages 10-13 years, 14-17 years, adults, and parents. Documents indicated in Greek (file titles include _GR).

Site Name: Nosokomeio Paidon I Agia Sofia
Department Name: Center for Cell and Gene Therapy, Children's Oncology Unit - Marianna V. Vardilogianni "ELPIDA"
Contact Person Name: Evgenios Goussetis
Contact Person Email: evgoussetis@gmail.com

{"country":"Greece","full_name":"Coronis Research S.A.","duties_or_roles":"Regulatory submissions, Contract Management, Pharmacovigilance reporting (sponsorDuties codes present in record)","organisation_type":"Pharmaceutical company"}

Investigational Product Name: DDCART‐CD19
Active Substance: DDCART‐CD19
Modality: Cell therapy
Routes Of Administration: Intravenous
Route: Intravenous
Maximum Dose: Max daily dose 5000000 (units: Other); Max total dose 10000000 (units: Other)

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