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New treatment option for T-Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma
Official title CD7-CAR-T Cells in Pediatric Relapsed/Refractory CD7+ T-ALL/LL
ClinicalTrials.gov ID: NCT06064903
What this study is testing
What is CD7-CART01?
CD7-CART01 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for t-cell acute lymphoblastic leukemia/lymphoblastic lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 25
You may be able to join if
- Procurement eligibility
- 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...
- 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...
- 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;
You likely can't join 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...
- Systemic chemotherapy in the 2 weeks preceding apheresis collection
See the full eligibility criteria
Who can join
- Procurement eligibility
- 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...
- 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 people \<18-year-old, or below the age required by each Country regulation, their legal guardian must give informed consent. Pediatric people will be included in age-appropriate...
- 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%.
What rules you out
- 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;
- people 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...
- 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 people \<18-year-old, or below the age required according to each Country regulation, their legal guardian must give informed consent. Pediatric people will be included in...
- 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%. Exclusion criteria:
- 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;
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Rome, Rome, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rome, Rome, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.