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Trial Title:
CAR T-cell Therapy Directed to CD70 for Pediatric Patients With Hematological Malignancies
NCT ID:
NCT06326463
Condition:
Hematologic Malignancy
ALL, Childhood
AML, Childhood
Lymphoma
MDS
Conditions: Official terms:
Neoplasms
Hematologic Neoplasms
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Cyclophosphamide
Fludarabine
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Fludarabine
Description:
40mg/m2, Day -4, -3 and -2
Arm group label:
CD70- CAR T cell Therapy
Other name:
Fludara
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Day -3 and Day-2
REST DAY, -1
Arm group label:
CD70- CAR T cell Therapy
Other name:
Cytoxan
Intervention type:
Drug
Intervention name:
CD70-CAR T cell infusion (Autologous)
Description:
Day 0 or +1
Arm group label:
CD70- CAR T cell Therapy
Intervention type:
Drug
Intervention name:
Mesna
Description:
Mesna is generally dosed at approximately 25% of the cyclophosphamide dose. It is
generally given intravenously prior to and again at 3, 6 and 9 hours following each dose
of cyclophosphamide
Arm group label:
CD70- CAR T cell Therapy
Other name:
Mesnex
Summary:
The study participant has one of the following blood cancers: acute myelogenous leukemia
(AML)/myelodysplastic syndrome (MDS), acute lymphoblastic leukemia (B-ALL, T-ALL) or
Lymphoma. Your cancer has been difficult to treat (refractory) or has come back after
treatment (relapse).
Primary Objective
To determine the safety and maximum tolerated dose of intravenous infusions of escalating
doses of CD70-CAR T cells in patients (≤21 years) with recurrent/refractory CD70+
hematological malignancies after lymphodepleting chemotherapy.
Secondary Objectives
To evaluate the antileukemic activity of CD70-CAR T cells. We will determine the anti-
leukemic activity of the CD70-CAR T cells in the bone marrow and in the treatment of
extramedullary disease.
Detailed description:
The primary interventions are a lymphodepleting chemotherapy regimen (fludarabine and
cyclophosphamide), followed by a single autologous infusion of CD70-CAR T cells.
Phase I study evaluating three (3) dose levels of CD70-CAR T cells.
Criteria for eligibility:
Criteria:
Inclusion Criteria
Age ≤21 years old
Relapsed/refractory CD70+ hematological malignancy
Relapsed disease: Patients developing recurrent disease after a prior complete remission
(CR)
Refractory disease: Patients with persistent disease despite 3 cycles of induction
chemotherapy.
- Relapsed/refractory CD70+ AML or MDS:
- Relapsed disease that is CD70 positive
- Refractory disease that is persistent despite 3 cycles of chemotherapy
- Relapsed/refractory CD70+ B-cell ALL:
- Relapsed disease that is CD70 positive and CD19 negative/dim or patients
otherwise ineligible for CD19-directed therapies including:
- Patients in 2nd or greater relapse
- Patients with relapse after allogeneic HSCT
- Relapsed/refractory CD70+ T-cell ALL:
- Relapsed /refractory disease that is CD70 positive
- Relapsed/refractory CD70+ lymphoma:
- Relapsed disease that is CD70 positive and CD19 negative/dim or patients
otherwise ineligible for CD19-directed therapies including:
- Patients in 2nd or greater relapse
- Patients with relapse after allogeneic HSCT
Estimated life expectancy of >12 weeks
Karnofsky or Lansky (age- dependent) performance score ≥50
Patients with a history of prior allogeneic HCT must be clinically recovered from prior
HCT therapy, have no evidence of active GVHD and have not received a donor lymphocyte
infusion (DLI) within the 28 days prior to apheresis
Patient must have an identified HCT donor
For females of childbearing age:
i. Not lactating with intent to breastfeed
ii. Not pregnant with negative serum or urine pregnancy test within 7 days prior to
enrollment
Exclusion Criteria
- Known primary immunodeficiency
- Known history of HIV positivity
- Severe intercurrent bacterial, viral or fungal infection
- History of hypersensitivity to cornstarch or hydroxyethyl starch
- Patients with acute promyelocytic leukemia (APL)
- Known contraindication to protocol defined lymphodepleting
- chemotherapy regimen of Fludarabine/cyclophosphamide
Gender:
All
Minimum age:
N/A
Maximum age:
21 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
St. Jude Children's Research Hospital
Address:
City:
Memphis
Zip:
38105
Country:
United States
Status:
Recruiting
Contact:
Last name:
Swati Naik, MD
Phone:
866-278-5833
Email:
referralinfo@stjude.org
Start date:
December 2024
Completion date:
July 1, 2031
Lead sponsor:
Agency:
St. Jude Children's Research Hospital
Agency class:
Other
Source:
St. Jude Children's Research Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06326463
http://www.stjude.org
http://www.stjude.org/protocols
