Allogeneic CARCIK-CD19 in Adults/Pediatric B-cell NHL or Chronic Lymphocytic Leukemia

Recruiting Phase 1 Phase 2 Interventional Study
B-cell NHL CLL
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
1 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
29 (estimated)
Sponsor
Fondazione Matilde Tettamanti Menotti De Marchi Onlus · Other
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About This Trial

This is a single arm, open-label, multi-center, phase I/II study to determine the engraftment, safety and clinical activity of allogeneic CARCIK-CD19 cells in adult and pediatric patients with relapsed/refractory mature B-cell neoplasia expected to express CD19 i.e. B-cell NHL and CLL. CARCIK-CD19 will be produced from the peripheral blood of an at least haploidentical familial donor.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: criteria apply: 1. Able and willing to provide written informed consent and to comply with the study protocol according to International Conference on Harmonization (ICH) and local regulations. 2. Ineligibility to commercially available CAR-T cells 3. Age limits: children (1-17…
Contacts

Andrea Biondi, MD

+39039233

segreteriadirezionecp@fondazionembbm.it

CONTACT

Alessandro Rambaldi, MD

+39035267

ematologiasegr@asst-pg23.it

CONTACT