CAR T-cell Therapy Directed to CD70 for Pediatric Patients With Hematological Malignancies

Launched by ST. JUDE CHILDREN'S RESEARCH HOSPITAL · Mar 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CAR T-cell therapy specifically for young patients (up to 21 years old) who have certain hard-to-treat blood cancers, such as acute myelogenous leukemia (AML), acute lymphoblastic leukemia (ALL), or lymphoma. This therapy uses a person’s own immune cells, modified in the lab to better fight cancer, and is being tested to see how safe it is and how well it works against these types of cancers that have either returned after treatment or haven’t responded to previous therapies.

To be eligible for this trial, patients must have a specific type of blood cancer that is CD70 positive and have either relapsed (come back after treatment) or refractory (did not get better after at least three rounds of initial treatment) disease. Participants will receive the modified T-cells through an intravenous infusion after undergoing a preparatory chemotherapy. Throughout the study, doctors will monitor their health closely to assess both the safety of the treatment and its effectiveness in treating the cancer. It's important to note that patients with certain health conditions, like severe infections or specific types of leukemia, may not be eligible for this trial.

Gender

ALL

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
• * 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
• • 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