CAR T-cell therapy for children with hard-to-treat blood cancers
CAR T-cell Therapy Directed to CD70 for Pediatric Patients With Hematological Malignancies
This study is testing a new CAR T-cell therapy to see if it can safely help children and young adults with tough-to-treat blood cancers like leukemia and lymphoma.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | N/A to 21 Years |
| Sex | All |
| Sponsor | St. Jude Children's Research Hospital Academic / other |
| Drugs / interventions | chemotherapy, cyclophosphamide, Fludarabine, CAR T |
| Locations | 1 site (Memphis, Tennessee) |
| Trial ID | NCT06326463 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and maximum tolerated dose of CD70-CAR T cells in pediatric patients (up to 21 years old) with relapsed or refractory CD70+ hematological malignancies, including acute myelogenous leukemia (AML), acute lymphoblastic leukemia (ALL), and lymphoma. Participants will undergo a lymphodepleting chemotherapy regimen followed by an infusion of autologous CD70-CAR T cells. The study aims to assess both the safety of the treatment and its effectiveness in combating these difficult-to-treat cancers.
Who should consider this trial
Good fit: Ideal candidates are children and young adults aged 21 years or younger with relapsed or refractory CD70+ hematological malignancies.
Not a fit: Patients with hematological malignancies that do not express CD70 or those who are older than 21 years may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for children with resistant forms of blood cancers.
How similar studies have performed: Other studies using CAR T-cell therapies have shown promising results, particularly in treating various forms of leukemia and lymphoma, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Memphis, Tennessee
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Swati Naik, MBBS — St. Jude
- Study coordinator: Swati Naik, MBBS
- Email: referralinfo@stjude.org
- Phone: 866-278-5833
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.