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

ConditionT-Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age6-25
SponsorBambino Gesù Hospital and Research Institute

About this trial

The main purpose of this study is to evaluate the safety, to establish the recommended dose, and to evaluate the antitumor effect of CD7-CART01 in pediatric patients with relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (T-LL).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

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;

CNS disease as defined as > 5 WBCs/mcL in CSF with morphological/flow-cytometry evidence of blasts or biopsy proven recurrence in the eye or brain;

Extramedullary relapse as defined by morphological evidence of blasts in the testis or any other extramedullary sites;

Disqualifiers

Severe, uncontrolled active intercurrent infections.

HIV, or active HCV and/or HBV infection.

Blast contamination in peripheral blood >5%, by flow-cytometry, at the time of leukapheresis collection.

Systemic steroids (at a dose equivalent to or greater than 2 mg/kg prednisone) in the 2 weeks before apheresis collection. Recent or current use of inhaled/topical/non-absorbable steroids is not exclusionary

Trial design

Design model

Single group

Treatments tested in this trial

  • CD7-CART01

    Biological/Vaccine

    A single IV infusion of CD7-CART01 on Day 0

Treatment groups

26 Participants
are divided into 1 treatment group
Group A: CD7-CART01Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
28 days
2

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

Time frame
28 days

Secondary outcomes

1

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

In the phase II portion of the study, the treatment-related adverse events will be recorded

Time frame
28 days
2

Antitumor effect of CD7-CART01 (Phase I and II)

To assess the Overall Response Rate (ORR) at day 28

Time frame
28 days
3

In vivo persistence of CD7-CART01 (Phase I and II)

To assess the in vivo persistence of the infused T cells using immunoassays and transgene detection (flow-cytometry and Real Time qPCR)

Time frame
3 years
4

Relative proportion and phenotype of CD3+CAR+ T cells/CD3+CAR- T cells/NK cells (Phase I and II)

To assess the relative proportion and phenotype of CD3+CAR+ T cells/CD3+CAR- T cells/NK cells at day +28 and whenever it will be the case at subsequent time points

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bambino Gesù Hospital and Research Institute

Lead sponsor

Source ClinicalTrials.gov
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