Status:
RECRUITING
Anti-CD7 CAR-T Cells in Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia or Lymphoma
Lead Sponsor:
Stephan Grupp MD PhD
Collaborating Sponsors:
Beam Therapeutics Inc.
Conditions:
T-Cell Acute Lymphoblastic Leukemia/Lymphoma
Eligibility:
All Genders
Up to 29 years
Phase:
PHASE1
Brief Summary
This will be a Phase 1, open-label study to evaluate the safety and efficacy of BEAM-201 in patients with R/R T-ALL or T-LLy. BEAM-201 is an allogeneic anti-CD7 CART therapy.
Detailed Description
Despite favorable outcomes in newly diagnosed patients, approximately 20% of pediatric and young adult T-ALL patients and 40% of adult patients will have refractory disease or will relapse within 2 ye...
Eligibility Criteria
Inclusion
- Patients must meet all the following criteria to be eligible for enrollment into the study:
- Patients (ages ≥ 18 years) or parent/legal guardians (for patients ages \< 18 years) must provide signed, written informed consent according to local IRB and institutional requirements.
- Ages 0 to 29 years.
- T-ALL/T-LLy in second or greater relapse, first relapse post-transplant, or chemotherapy-refractory disease. Specifically:
- Second or greater relapse or post-transplant relapse, defined as:
- BM with ≥ 5% lymphoblasts by morphologic assessment or evidence of extramedullary disease after second documented CR; OR
- Flow cytometric confirmation of relapsed T-ALL of at least 0.1% after second CR documented to have been MRD negative \< 0.1%; OR
- Any detectable relapsed disease post-allogeneic HSCT with flow cytometric confirmation of T-ALL of at least 0.1%; OR
- Biopsy confirmed evidence of relapsed T-LLy after second CR; OR
- Any detectable disease post-allogeneic transplant with biopsy confirmed evidence of T-LLy
- Refractory disease, defined as:
- Primary refractory T-ALL or T-LLy, defined as failure to achieve CR after induction chemotherapy, per investigator assessment and based on biopsy-or MRD-confirmed evidence of residual T-ALL or T-LLy; OR
- Relapsed, refractory disease, defined as \> 0.1 % MRD or morphologic evidence of disease or evidence of residual T-LLy after 1 course of re-induction chemotherapy for patients who have relapsed after previously achieving a CR NOTE: Patients with mixed phenotype acute leukemia with T cell dominant phenotype may be enrolled if the aforementioned criteria are met.
- Documentation of CD7 expression on leukemic or T-LLy blasts (defined as at least 90% of blasts positive for CD7 by flow cytometry or immunohistochemistry).
- Patients with prior or current history of CNS3 disease will be eligible if CNS disease is responsive to therapy
- Eligible for myeloablative conditioning for and allogeneic HSCT based on the investigator's assessment with an available donor identified by a FACT accredited transplant center.
- Lansky Performance Status (ages \< 16 years at time of consent) or Karnofsky Performance Status (KPS) (ages ≥ 16 years at time of consent) score of ≥ 50.
- Patients of childbearing potential must have a negative urine or serum pregnancy test at screening.
- Adequate organ function defined as:
- Adequate Serum creatinine based on age/gender
- ALT ≤ 5x ULN in the absence of ALL infiltration of the liver
- Bilirubin ≤ 3 × ULN for age Note: ALT and/or bilirubin results that exceed this range are acceptable if, in the opinion of the physician-investigator (or as confirmed by liver biopsy), the abnormalities are directly related to ALL infiltration of the liver.
- Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and \<Grade 3 hypoxia; DLCO ≥40% (corrected for anemia if necessary) if PFTs are clinically appropriate as determined by the investigator.
- Cardiac echocardiography (ECHO) with left ventricular shortening fraction (LVSF) ≥ 30% or left ventricular ejection fraction (LVEF) ≥ 50%. In cases where quantitative assessment of LVSF/LVEF is not possible, a statement by the cardiologist that the ECHO shows qualitatively normal ventricular function will suffice
- Patients who are sexually active and of reproductive potential must agree to use an acceptable form of highly effective contraception from consent to 12 months after BEAM 201 infusion.
- 2 Exclusion Criteria
- Patients who meet any of the following criteria will be disqualified from entering the study:
- Active hepatitis B or active hepatitis C
- Active HTLV infection
- HIV infection
- Uncontrolled, active bacterial, viral, or fungal infection.
- CNS disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity.
- Clinically active CNS dysfunction or known history of irreversible central neurological toxicity related to prior antileukemic therapy.
- Receipt of prior CD7 targeted therapy.
- Radiation therapy within 2 weeks prior to completion of screening, other than prophylaxis for CNS disease.
- Acute GVHD that is grade ≥ 2 and requiring systemic immunosuppression (corticosteroids), or chronic GVHD that is mild, moderate, or severe and requiring systemic immunosuppression (corticosteroids). Grade 1 acute GVHD not requiring immunosuppression is allowable.
- Undergone HSCT within 90 days prior to completion of screening (or donor leukocyte infusion, if received within 30 days prior to completion of screening).
- Any other condition that would make the patient ineligible for HSCT as determined by the investigator.
- Known primary immunodeficiency or BM failure syndrome.
- Atrial fibrillation/flutter (not including isolated episodes that responded to medical management)
- Clinically significant pericardial effusion
- Myocardial infarction within the last 12 months
- QT interval corrected for heart rate \> 480 msec
- Cardiac dysfunction NYHA (New York Heart Association) III or IV
- Patients with an autoimmune disorder requiring systemic immunosuppressive therapy that cannot be safely withheld for 3 months.
- Concurrent use of systemic corticosteroids for diagnoses unrelated to T-ALL/T-LLy is prohibited, with exception of physiologic corticosteroid replacement therapy treatment for adrenal insufficiency.
- Pregnant or breastfeeding
Exclusion
Key Trial Info
Start Date :
April 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2031
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT06934382
Start Date
April 29 2025
End Date
May 30 2031
Last Update
December 26 2025
Active Locations (1)
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1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104