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T-Cell Acute Lymphoblastic Leukemia/Lymphoblastic LymphomaPhase 1/2CD7-CAR01NCT06064903

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

A Phase 1/2 study testing CD7-CART01 in people with T-Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma, run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 6 months to 25 years
What is being tested?
CD7-CART01
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteItaly
Study dates
21 Apr 2024to 30 Sep 2040
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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;
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  • 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%.
  • 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.
  • Before enrollment for treatment, patients must have a potential allogeneic hematopoietic stem cell (HSC) donor (matched related, matched unrelated or haploidentical) available.
  • Voluntary informed consent is given. For subjects <18-year-old, or below the age required according to 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 the 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%.

Who cannot join

  • 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
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  • 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
  • Pregnant or lactating women.
  • Severe, uncontrolled active intercurrent infections.
  • HIV, or active HCV and/or HBV infection.
  • Life-expectancy < 6 weeks.
  • Hepatic function: Inadequate liver function defined as total bilirubin > 4x upper limit of normal (ULN) or transaminase (ALT and AST) > 6 x ULN.
  • Renal function: serum creatinine > 3x ULN for age.
  • Blood oxygen saturation < 90%.
  • Cardiac function: Left ventricular ejection fraction lower than 45% by ECHO.
  • Congestive heart failure, cardiac arrhythmia, psychiatric illness, or social situations that would limit compliance with study requirements or in the opinion of the PI would pose an unacceptable risk to the subject.
  • Uncontrolled seizures or status epilepticus; increased intra-cranial pressure as evidenced by papilledema and CSF opening pressure > 20 cm water; decreased conscious state (any cause).
  • Contamination of either the apheresis collection or the CD7-CART01 drug product with >5% blasts.
  • Presence of active, grade 2-4 acute or extensive chronic GvHD.
  • Concurrent or recent prior therapies, before infusion:
  • Systemic steroids (at a dose > 2 mg/kg prednisone) in the 2 weeks before infusion. Recent or current use of inhaled/topical/non-absorbable steroids is not exclusionary
  • Systemic chemotherapy in the 2 weeks preceding infusion
  • Anti-thymocyte globulin (ATG) or Alemtuzumab (Campath®) in the 8 weeks preceding infusion
  • Immunosuppressive agents in the 2 weeks preceding infusion
  • Radiation therapy must have been completed at least 3 weeks prior to enrollment
  • Other anti-neoplastic investigational agents currently administered or within 30 days prior to infusion (i.e., start of protocol therapy)
  • Exceptions:
  • There is no time restriction in regards to prior intrathecal chemotherapy but there must be a complete recovery from any acute toxic effects from 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 that they meet all other eligibility criteria;
  • Subjects receiving steroid therapy at physiologic replacement doses only are allowed provided that there has been no increase in dose for at least 2 weeks prior to starting apheresis.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Franco Locatelli, MD, PhD contact

+3966859 ext. 2678

franco.locatelli@opbg.net

Francesca Del Bufalo, MD, PhD contact

+3966859 ext. 2739

francesca.delbufalo@opbg.net

Italy1 site, 1 recruiting

  • Ospedale Pediatrico Bambino Gesù

    Rome, Rome, 00165

    Franco Locatelli, MD PhD, 066859 ext. 2678, franco.locatelli@opbg.net

    Francesca Del Bufalo, MD PhD, 066859 ext. 2739, francesca.delbufalo@opbg.net

    Recruiting

Other trials in Italy

About this study

Official title: Phase I/II Study of Anti-CD7 Chimeric Antigen Receptor-Expressing T Cells in Pediatric Patients Affected by Relapsed/Refractory CD7+ T-cell Acute Lymphoblastic Leukemia/Lymphoma

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).

Read the detailed description

This is an in-human, open-lable, single-arm, single-agent, Phase 1/2 study in pediatric patients with R/R T-ALL/T-LL who have failed at least one standard frontline chemotherapy or relapsed after allogeneic hematopoietic stem cell transplantation (HSCT). The study will consist of two phases, Phase 1 and Phase 2. During the Dose Escalation portion of the trial (Phase 1) up to 12 patients will receive CD7-CART01, in up to 2 dose levels until maximum tolerated dose (MTD) is determined. If 2 DLTs are observed in the dose level 1 an additional DL0 will be explored. The dose escalation phase will enroll successive cohorts of 3 up to 6 patients guided by a standard dose-finding 3 + 3 design. Once the recommended phase 2 dose (RP2D) is defined, the phase 2 portion of the study will enroll at the MTD/RD identified in the phase I up to 26 pediatric patients (for both phases) and the study protocol will be amended to include additional, international centers.

Being tested
CD7-CART01
Keywords
T-ALL, T-LL, Relapsed, Refractory, anti-CD7 PEBL-CAR T
Medical subject headings
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CD7-CART01Biological

    A single IV infusion of CD7-CART01 on Day 0

Study groups in NCT06064903
Study groupRoleWhat they receive
CD7-CART01ExperimentalA single IV infusion of CD7-CART01 (CD7-directed chimeric antigen receptor T-cells) on Day 0 after lymphodepleting regimen. Patients will receive the following lymphodepleting regimen: * Fludarabine 30 mg/m2 per day over 1 hour on days -6, -5, -4 and -3 * Cyclophosphamide 1000 mg/m2 per day on days -4 and -3. CD7-CART01 will be infused at the following dose levels: * DL1: 0.5 x 10^6 CAR+ cells/kg * DL2: 1 x 10^6 CAR+ cells/kg If 2 DLTs are observed an additional DL0 of 0.25 x 106 CAR+ cells /kg will be explored.
Receives: Biological: CD7-CART01

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety (Phase I) and definition of the recommended dose (Phase I)

    To evaluate the safety of the infusion of CD7-CART01, explore the dose-limiting toxicities (DLT) of the cellular product and define the recommended dose of CD7-CART01, defined as the maximum tolerated dose/recommended dose (MTD/RD), to be evaluated for efficacy in the phase II extension

    Measured: 28 days

  2. Antitumor effect of CD7-CART01 (Phase II)

    To evaluate the portion of patients achieving either BM, PB and CSF morphological complete remission (CR) or CR with incomplete blood count recovery (CRi) and with minimal residual disease (MRD) negativity at day 28

    Measured: 28 days

Secondary outcomes (7)

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    In the phase II portion of the study, the treatment-related adverse events will be recorded

    Measured: 28 days

  2. Antitumor effect of CD7-CART01 (Phase I and II)

    To assess the Overall Response Rate (ORR) at day 28

    Measured: 28 days

  3. In vivo persistence of CD7-CART01 (Phase I and II)

    To assess the in vivo persistence of the infused T cells using immunoassays and transgene detection (flow-cytometry and Real Time qPCR)

    Measured: 3 years

  4. Relative proportion and phenotype of CD3+CAR+ T cells/CD3+CAR- T cells/NK cells (Phase I and II)

    To assess the relative proportion and phenotype of CD3+CAR+ T cells/CD3+CAR- T cells/NK cells at day +28 and whenever it will be the case at subsequent time points

    Measured: 3 years

  5. Assessment of cumulative incidence of relapse

    To assess the cumulative incidence of both molecular and morphological relapse (defined as an MRD >10^-4 and a BM blast percentage > 5%, respectively)

    Measured: 3 years

  6. Assessment of cumulative incidence of overall survival

    To assess the cumulative incidence of overall survival at 1 and 3 years post cell infusion

    Measured: 3 years

  7. Assessment of cumulative incidence of disease-free survival

    To assess the cumulative incidence of disease-free survival at 1 and 3 years post cell infusion

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2023
  2. Study start21 Apr 2024
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion30 Sep 2040 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06064903
Sponsor's protocol ID
CD7-CAR01
Acronym
CD7-CAR01
Status last verified
Nov 2025
First submitted
12 Sep 2023
Last updated
2 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CD7-CART01 in people with T-Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma, run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Franco Locatelli, MD, PhD (+3966859 ext. 2678, franco.locatelli@opbg.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (Phase I) and definition of the recommended dose (Phase I) (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06064903.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.

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