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.
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
Mixed Phenotype Acute Leukemia (MPAL):
* Relapsed/refractory 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
You may not be if
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
Clareo Health | CAR T-cell Therapy Directed to CD70 for Pediatric Patients With Hematological Malignancies
