Trials Sponsors Conditions Drugs Pricing

Conditions

T-Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma

Keywords

T-ALLT-LLRelapsedRefractoryanti-CD7 PEBL-CAR T

Outcome Measures

Primary Outcomes (2)

Safety (Phase I) and definition of the recommended dose (Phase I)
To evaluate the safety of the infusion of CD7-CART01, explore the dose-limiting toxicities (DLT) of the cellular product and define the recommended dose of CD7-CART01, defined as the maximum tolerated dose/recommended dose (MTD/RD), to be evaluated for efficacy in the phase II extension
28 days
Antitumor effect of CD7-CART01 (Phase II)
To evaluate the portion of patients achieving either BM, PB and CSF morphological complete remission (CR) or CR with incomplete blood count recovery (CRi) and with minimal residual disease (MRD) negativity at day 28
28 days

Secondary Outcomes (7)

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
28 days
Antitumor effect of CD7-CART01 (Phase I and II)
28 days
In vivo persistence of CD7-CART01 (Phase I and II)
3 years
Relative proportion and phenotype of CD3+CAR+ T cells/CD3+CAR- T cells/NK cells (Phase I and II)
3 years
Assessment of cumulative incidence of relapse
3 years
+2 more secondary outcomes

Study Arms (1)

CD7-CART01

EXPERIMENTAL

A single IV infusion of CD7-CART01 (CD7-directed chimeric antigen receptor T-cells) on Day 0 after lymphodepleting regimen. Patients will receive the following lymphodepleting regimen: * Fludarabine 30 mg/m2 per day over 1 hour on days -6, -5, -4 and -3 * Cyclophosphamide 1000 mg/m2 per day on days -4 and -3. CD7-CART01 will be infused at the following dose levels: * DL1: 0.5 x 10\^6 CAR+ cells/kg * DL2: 1 x 10\^6 CAR+ cells/kg If 2 DLTs are observed an additional DL0 of 0.25 x 106 CAR+ cells /kg will be explored.

Biological: CD7-CART01

Interventions

CD7-CART01Biological

A single IV infusion of CD7-CART01 on Day 0

CD7-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:

Diagnosis of CD7 expressing (\> 98% CD7 expression on blast cells) T-ALL or LL and one of the following:
Patients in 1st or subsequent relapse, after at least one standard frontline chemotherapy with BM involvement (MRD \>1% in 2 consecutive determinations or evidence of morphological relapse, i.e. \>5% blasts in BM);

Sponsors & Collaborators

Bambino Gesù Hospital and Research Institute
Otherlead

Study Sites (1)

Ospedale Pediatrico Bambino Gesù

Rome, Rome, 00165, Italy

RECRUITING

Franco Locatelli, MD PhDCONTACT066859 ext. 2678 franco.locatelli@opbg.net

Francesca Del Bufalo, MD PhDCONTACT066859 ext. 2739 francesca.delbufalo@opbg.net

Franco Locatelli, MD PhDPRINCIPAL INVESTIGATOR

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-LymphomaPrecursor Cell Lymphoblastic Leukemia-LymphomaRecurrence

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic Processes

Study Officials

Franco Locatelli, MD, PhD
Director Department of Hematology/Oncology and Cell and Gene Therapy
PRINCIPAL INVESTIGATOR

Central Study Contacts

Franco Locatelli, MD, PhD

CONTACT

+3966859 franco.locatelli@opbg.net

Francesca Del Bufalo, MD, PhD

CONTACT

+3966859

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 12, 2023

First Posted

October 3, 2023

Study Start

April 21, 2024

Actual (reported)

Primary Completion

September 30, 2028

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

CD7-CAR-T Cells in Pediatric Relapsed/Refractory CD7+ T-ALL/LL

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 (7)

Study Arms (1)

CD7-CART01

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

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 (7)

Study Arms (1)

CD7-CART01

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations