Trials Sponsors Conditions Drugs Pricing

Conditions

CD19-ALL CD19-LNH

Keywords

CD19-CAR T cellCD19-malignancyCAR T cellCD19-ALLCD19-LNH

Outcome Measures

Primary Outcomes (2)

Phase I - Identification of the dose limiting toxicity (DLT)
Toxicity will be assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) scale, version 4 and the number of patients experiencing DLT will be evaluated
4 weeks after CAR T cell infusion
Phase II - Efficacy
Complete remission rate minimal residual disease (MRD) negative response
4 weeks after CAR T cell infusion

Secondary Outcomes (8)

Overall Response Rate (ORR)
4 weeks after CAR T cell infusion
In vivo persistence/expansion of infused CAR T cell
Up to 5 years
Function of infused CAR T cell
Up to 5 years
Cytokine profiling
10 days after CAR T cell infusion
Disease Outcome
Up to 3 years
+3 more secondary outcomes

Study Arms (1)

CD19-CART01

EXPERIMENTAL

Following the lymphodepleting treatment, with patients will be treated with 0.5 to 3.0 x 10⁶/kg CD19 Chimeric Antigen Receptor (CAR) positive T cells as a single dose

Biological: CD19-CAR T cell

Interventions

CD19-CAR T cellBiological

Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with 0.5 to 3.0 x 10⁶/kg CD19 Chimeric Antigen Receptor (CAR) positive T cells as a single dose. In case of toxicity, the patient will receive the dimerizing drug activating the suicide safety switch in order to improve the safety of the treatment

CD19-CART01

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age6 Months - 25 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

Male and female subjects with CD19 expressing B-cell acute lymphoblastic leukemia (ALL) or Non-Hodgkin Lymphoma (NHL) with BM involvement and one of the following:
i. Patients in 2nd or subsequent relapse, after at least one standard frontline chemotherapy and one salvage regimen, with BM involvement ii. Relapse after allogeneic HSCT, if at least 100 days post-transplant, if there is no evidence of active GVHD and if the patient is no longer taking immunosuppressive agents for at least 30 days prior to enrollment iii. MRD \> 0.1% after either reinduction therapy or any course of consolidation for relapsed ALL

Sponsors & Collaborators

Bambino Gesù Hospital and Research Institute
Otherlead

Study Sites (1)

Ospedale Pediatrico Bambino Gesù

Roma, Italy

Related Publications (1)

Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.
PMID: 34515338DERIVED

Enrollment

29 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Haematology-Oncology Department Chief

Study Record Dates

First Submitted

December 6, 2017

First Posted

December 14, 2017

Study Start

December 23, 2017

Actual (reported)

Anti-CD19 CAR T Cells in Pediatric Patients Affected by Relapsed/Refractory CD19+ ALL and NHL

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (8)

Study Arms (1)

CD19-CART01

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (8)

Study Arms (1)

CD19-CART01

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations