Health TrialsbyHealthPanel

Clinical Trial Using CAR- T Cells for Treatment of Patients With Refractory or Relapsed CD19-positive B Lymphoid Malignancies

ConditionsAcute Lymphoblastic Leukemia, in RelapseAcute Lymphoblastic Leukemia RefractoryB-cell Lymphoma RecurrentB-cell Lymphoma RefractoryChronic Lymphocytic Leukemia RecurrentChronic Lymphocytic Leukemia Refractory
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age2-70
SponsorNelson Hamerschlak

About this trial

This is a phase l, single arm, prospective open, dose-escalation study in patients with relapsed or refractory CD19-positive B cell malignancies (ALL, NHL, CLL). The trial will include adult and pediatric patients. There will be three individual cohorts, defined by disease biology: pediatric ALL and aggressive pediatric NHL (Cohort 1), adult ALL (Cohort 2) and adult NHL/CLL (Cohort 3).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects must have relapsed or refractory ALL, lymphoma or CLL treated with at least two lines of therapy. Disease must have either progressed after the last regimen or presented failure to achieve partial or complete remission with the last regimen.

2. The patient's disease must be CD19 positive, either by immunohistochemistry or flow cytometry analysis on the last biopsy available.

Age 2 to 70 years.

Performance status: Adult Subjects: ECOG ≤ 2 for patients ≥ 16 years; Subjects < 16 years of age: lansky ≥ 50%

Disqualifiers

Autologous transplant within 6 weeks of planned CAR-T cell infusion;

History of allogeneic stem cell transplant 4 months prior CAR T cell infusion.

Use of immunosuppression therapy;

Presence of graft-versus-host disease Grade ≥ 2;

Trial design

Design model

Single group

Treatments tested in this trial

  • Cyclophosphamide

    Drug

    Cyclophosphamide 60mg/Kg on day -6

  • Fludarabine

    Drug

    Fludarabine 25mg/m\^2 IV on days -5 to -3

  • Chimeric antigen receptor T cells to be implemented in a "3 + 3" design on day 0

    Biological/Vaccine

    Level -1 (1 x 105 cells/kg) Level 1 \[Starting dose\] (5 x 105 cells/kg) Level 2 (1 x 106 cells/kg) Level 3 (2 x 106 cells/kg)

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Cyclophosphamide + Fludarabine + Infusion of CAR-T CellsExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Determination of the recommended dose of CAR-T cells for a future phase II study

The RP2D will be the maximum tolerated dose (MTD) or the highest dose studied if an MTD is not obtained.

Time frame
Until day 28 after CAR-T cells infusion

Secondary outcomes

1

Response to treatment for each timepoint.

ORR in ALL (Rate of CR/CRh)

Time frame
day 28
2

Response to treatment for each timepoint

ORR in NHL/CLL (Rate of CR/CRh)

Time frame
day 28, patients not in CR on day 28: month 3
3

Assess overall survival (OS), progression-free survival (PFS).

Overall survival (OS) and progression-free survival (PFS) will be assessed by dose cohort and in the first two groups at the MTD (or at the highest dose studied).

Time frame
at 1 year after CAR-T infusion
4

Phenotype and persistence of CAR-T

Blood samples for determination of persistence/phenotyping of infused CAR-T cells will be analysed.

Time frame
days 2, 7, 10, 14, 28, weeks 8, 12, months 6, 12, 24, 36, 48, 60

Other outcomes

Sponsors and contacts

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

Nelson Hamerschlak

Lead sponsor

Hospital Israelita Albert Einstein

Sponsor institution

Miltenyi Biotec, Inc.

Collaborator

Source ClinicalTrials.gov
Apply now