CAR T-cell therapy for children with hard-to-treat blood cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CAR-T therapy outcomes and quality of life in older adults with B‑cell lymphoma

  This project will see how CAR‑T therapy affects older adults (age 60+) with relapsed or refractory B‑cell lymphomas, focusing on daily function and quality of life while they receive standard care.

  Recruiting Memorial Sloan Kettering Cancer Center · New York, New York · NCT04300998

• CD19/CD22 CAR-T consolidation after second-line therapy for high-risk aggressive B-cell lymphoma

  This trial tests whether CD19/CD22 CAR-T cell therapy given after a second-line response can help people with high-risk aggressive B-cell lymphoma stay in remission.

  Recruiting Phase 2 Chinese PLA General Hospital · Beijing · NCT07779018

• In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma

  This early-phase trial tests a one-time in vivo CAR T-cell therapy (SL1617) for people with relapsed or refractory B-cell lymphoma to see if it is safe and tolerable.

  Recruiting Phase 1 Chinese PLA General Hospital · Beijing · NCT07775508

• Identifying biomarkers for CAR-T cell therapy in cancer patients

  This study looks at real-world CAR-T therapy in adults with blood cancers to see which biomarkers predict who responds or relapses.

  Recruiting University Hospital, Lille · Lille and 1 other locations · NCT07609485

• CD19/CD22 CAR-T as first-line consolidation for follicular lymphoma

  This trial tests whether CAR-T cells targeting CD19 and CD22 can be used as a first-line consolidation therapy for people with follicular lymphoma to see if it improves outcomes.

  Recruiting Phase 2 Chinese PLA General Hospital · Beijing, Beijing Municipality · NCT07587840

• Dynamic individualized risk profiling for patients receiving CD19 CAR T-cell therapy

  This project tries a combined blood, imaging, and lab test to predict which adults with relapsed or refractory B‑cell lymphoma will do well after CD19 CAR T‑cell therapy.

  Recruiting University of Zurich · Zurich, Canton of Zurich · NCT07472972

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.