CD7-CAR-T Cells in Pediatric Relapsed/Refractory CD7+ T-ALL/LL

Recruiting now · Phase 1/Phase 2

Conditions studied: T-Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma

In brief

The main purpose of this study is to evaluate the safety, to establish the recommended dose, and to evaluate the antitumor effect of CD7-CART01 in pediatric patients with relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (T-LL).

Key facts

Study ID

NCT06064903

Run by

Bambino Gesù Hospital and Research Institute

People needed

26

Starts

2024-04-21

Expected to finish

2040-09-30

Last updated by the study team

2025-12-02

Who can join

Age: 1 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of CD7 expressing (> 98% CD7 expression on blast cells) T-ALL or LL and one of the following:
• Patients in 1st or subsequent relapse, after at least one standard frontline chemotherapy with BM involvement (MRD >1% in 2 consecutive determinations or evidence of morphological relapse, i.e. >5% blasts in BM);
• Relapse after allogeneic HSCT, if at least 100 days post-transplant, if there is no evidence of active GVHD and if the patient is no longer taking immunosuppressive agents for at least 30 days prior to enrollment;
• CNS disease as defined as > 5 WBCs/mcL in CSF with morphological/flow-cytometry evidence of blasts or biopsy proven recurrence in the eye or brain;
• Extramedullary relapse as defined by morphological evidence of blasts in the testis or any other extramedullary sites;
• Refractory disease, defined as MRD ≥ 1% or <1% but persistently positive (i.e. a positive MRD value confirmed by PCR at 2 subsequent evaluations performed at least 2 weeks apart), at the end of consolidation blocks in newly diagnosed patients;
• Age: 6 months - 25 years.
• Adequate venous access for apheresis or eligible for appropriate catheter placement, and no other contraindications for leukapheresis.
• Voluntary informed consent is given. For subjects <18-year-old, or below the age required by each Country regulation, their legal guardian must give informed consent. Pediatric subjects will be included in age-appropriate discussion and verbal assent will be obtained for those greater than or equal to 12 years of age, when appropriate, or to sign age-adapted informed consent, according to the regulatory requirement of each Country.
• Clinical performance status: Patients > 16 years of age: Karnofsky greater than or equal to 60%; Patients < 16 years of age: Lansky scale greater than or equal to 60%.

You may not qualify if…

• Severe, uncontrolled active intercurrent infections.
• HIV, or active HCV and/or HBV infection.
• Blast contamination in peripheral blood >5%, by flow-cytometry, at the time of leukapheresis collection.
• Concurrent or recent prior therapies, before apheresis:
• Systemic steroids (at a dose equivalent to or greater than 2 mg/kg prednisone) in the 2 weeks before apheresis collection. Recent or current use of inhaled/topical/non-absorbable steroids is not exclusionary
• Systemic chemotherapy in the 2 weeks preceding apheresis collection
• Nelarabine, daratumomab, clofarabine exposure in the 3 weeks preceding apheresis collection
• Anti-thymocyte globulin (ATG) or Alemtuzumab (Campath®) in the 8 weeks preceding apheresis collection
• Immunosuppressive agents in the 2 weeks preceding apheresis collection
• Radiation therapy must have been completed at least 2 weeks prior to apheresis
• Other anti-neoplastic investigational agents currently administered or within 30 days prior to apheresis (i.e. start of protocol therapy)
• Exceptions:
• There is no time restriction with regard to prior intrathecal chemotherapy, provided that there is complete recovery from any acute toxic effects of such chemotherapy;
• Patients who relapse while receiving standard ALL maintenance chemotherapy will not be required to have a waiting period before entry onto this study provided they meet all other eligibility criteria;
• Subjects receiving steroid therapy at physiologic replacement doses only are allowed provided there has been no increase in dose for at least 2 weeks prior to starting apheresis.
• Treatment eligibility
• Inclusion criteria:
• Diagnosis of CD7 expressing (> 98% CD7 expression on blast cells) T-ALL or LL and one of the following:
• Patients in 1st or subsequent relapse, after at least one standard frontline chemotherapy with BM involvement (MRD >1% in 2 consecutive determinations or evidence of morphological relapse, i.e. >5% blasts in BM)
• Relapse after allogeneic HSCT, if at least 100 days post-transplant, if there is no evidence of active GVHD and if the patient is no longer taking immunosuppressive agents for at least 30 days prior to enrollment
• CNS disease as defined as > 5 WBCs/mcL in CSF with morphological or flow-cytometry evidence of blasts or biopsy proven recurrence in the eye or brain
• Extramedullary relapse as defined by morphological evidence of blasts in the testis or any other extramedullary sites
• Refractory disease, defined as MRD ≥1% or <1% but persistently positive (i.e. a positive MRD value confirmed by PCR at 2 subsequent evaluations performed at least 2 weeks apart), at the end of consolidation blocks in newly diagnosed patients
• Measurable or evaluable disease at the time of enrollment, which may include any evidence of disease, including MRD detected by flow-cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis.
• Age: 6 months - 25 years.

Where it is running

• Ospedale Pediatrico Bambino Gesù — Rome, Rome, Italy (enrolling)

Full record on ClinicalTrials.gov

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