Active — Not RecruitingPhase 1/2

CD19-CAR_Lenti T Cells in Pediatric Patients Affected by Relapsed/Refractory CD19+ ALL and DLBCL or PML

Italy32 participantsStarted 2021-03-04

Plain-language summary

This study aims at evaluating the feasibility and safety of the administration of autologous T cells that have been modified through the introduction of a chimeric antigen receptor targeting the B-cell surface antigen CD19, following administration of lymphodepleting chemotherapy regimen, in children and adults with relapsed/refractory B-cell acute lymphoblastic leukemia (B- ALL) or aggressive B-cell Non-Hodgkin lymphoma (B-NHL). The phase II extension is aimed at testing the efficacy of the treatment at the optimal dose defined in the phase I. In addition, the investigators hypothesize that it is feasible to successfully manufacture CAR T cells to meet the established release criteria at a maximum target dose of 3.0 x 10\^6 cells/kilogram recipient total body weight in this patient population using the Miltenyi CliniMACS Prodigy® closed transduction system.

Who can participate

Age range1 Year – 25 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Diagnosis of CD19 expressing B-ALL or DLBCL or PML and one of the following:
✓. Patients in 1st relapse, with High-Risk (HR) features including: MLL- rearrangements, E2A/TCF3-PBX1, TCF3-HLF \[t(17;19)\], hypodiploidy (i.e., \<44 chromosomes), TP53 alterations, early (i.e., \<30 months from diagnosis)/very early (i.e., \<18 months from diagnosis) isolated or combined bone marrow relapse
✓. MRD \> 0.1% after either reinduction therapy or any course of consolidation for relapsed ALL
✓. Patients with DLBCL or PML in 1st or subsequent relapse, after at least one standard frontline chemotherapy
✓. Age: 1 year - 25 years for Bcp-ALL and 1-35 years for B-NHL.
✓. Voluntary informed consent is given. For subjects \< 18 year-old their legal guardian must give informed consent. Pediatric subjects will be included in age-appropriate discussion and verbal assent will be obtained for those greater than or equal to 12 years of age, when appropriate.
✓. Clinical performance status: Patients \> 16 years of age: Karnofsky greater than or equal to 60%; Patients \< 16 years of age: Lansky scale greater than or equal to 60%.
✓. Patients of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four months after receiving the preparative regimen.

What they're measuring

Phase I - Identification of dose limiting toxicities (DLTs) and recommended dose (RD)

Timeframe: 4 weeks after CAR T cell infusion

Phase I - Identification of recommended dose (RD)

Timeframe: 4 weeks after CAR T cell infusion of the last patient in the last dose level

Phase II - Efficacy

Timeframe: Up to 6 months after CAR T cell infusion

Trial details

NCT IDNCT04787263

SponsorBambino Gesù Hospital and Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03

View on ClinicalTrials.gov More Acute Lymphoblastic Leukemia trials

Plain-language summary

Who can participate

Age range1 Year – 25 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Diagnosis of CD19 expressing B-ALL or DLBCL or PML and one of the following:
✓. Patients in 1st relapse, with High-Risk (HR) features including: MLL- rearrangements, E2A/TCF3-PBX1, TCF3-HLF \[t(17;19)\], hypodiploidy (i.e., \<44 chromosomes), TP53 alterations, early (i.e., \<30 months from diagnosis)/very early (i.e., \<18 months from diagnosis) isolated or combined bone marrow relapse
✓. MRD \> 0.1% after either reinduction therapy or any course of consolidation for relapsed ALL
✓. Patients with DLBCL or PML in 1st or subsequent relapse, after at least one standard frontline chemotherapy
✓. Age: 1 year - 25 years for Bcp-ALL and 1-35 years for B-NHL.
✓. Voluntary informed consent is given. For subjects \< 18 year-old their legal guardian must give informed consent. Pediatric subjects will be included in age-appropriate discussion and verbal assent will be obtained for those greater than or equal to 12 years of age, when appropriate.
✓. Clinical performance status: Patients \> 16 years of age: Karnofsky greater than or equal to 60%; Patients \< 16 years of age: Lansky scale greater than or equal to 60%.
✓. Patients of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four months after receiving the preparative regimen.

What they're measuring

Phase I - Identification of dose limiting toxicities (DLTs) and recommended dose (RD)

Timeframe: 4 weeks after CAR T cell infusion

Phase I - Identification of recommended dose (RD)

Timeframe: 4 weeks after CAR T cell infusion of the last patient in the last dose level

Phase II - Efficacy

Timeframe: Up to 6 months after CAR T cell infusion

CD19-CAR_Lenti T Cells in Pediatric Patients Affected by Relapsed/Refractory CD19+ ALL and DLBCL or PML

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

CD19-CAR_Lenti T Cells in Pediatric Patients Affected by Relapsed/Refractory CD19+ ALL and DLBCL or PML

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Exclusion criteria