Actively Recruiting
Anti-CD7 CAR-T Cells in Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia or Lymphoma
Led by Stephan Grupp MD PhD · Updated on 2025-12-26
33
Participants Needed
1
Research Sites
317 weeks
Total Duration
On this page
Sponsors
S
Stephan Grupp MD PhD
Lead Sponsor
B
Beam Therapeutics Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Anti-CD7 CAR-T Cells in Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia or Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 0 to 29 years
- Signed informed consent from patients (if age �318) or parent/legal guardian (if under 18)
- Diagnosis of T-ALL or T-LLy in second or greater relapse, first relapse after transplant, or chemotherapy-refractory disease
- Documentation of CD7 expression on at least 90% of leukemic or lymphoblastic lymphoma blasts
- Eligible for myeloablative conditioning and allogeneic HSCT with an identified donor
- Lansky or Karnofsky Performance Status score of 50 or higher
- Negative pregnancy test for patients of childbearing potential
- Adequate organ function including kidney, liver, lung, and heart function
- Agreement to use effective contraception from consent to 12 months after BEAM-201 infusion
You will not qualify if you...
- Active hepatitis B or C infection
- Active HTLV infection
- HIV infection
- Uncontrolled active bacterial, viral, or fungal infections
- Progressive CNS disease or CNS lesions increasing risk of toxicity
- Clinically active CNS dysfunction or irreversible neurological toxicity from prior therapy
- Prior receipt of CD7 targeted therapy
- Radiation therapy within 2 weeks before screening (except CNS prophylaxis)
- Acute graft-versus-host disease (GVHD) grade 2 or higher requiring immunosuppression
- Chronic GVHD requiring systemic immunosuppression
- Hematopoietic stem cell transplant within 90 days or donor leukocyte infusion within 30 days before screening
- Any condition making patient ineligible for HSCT
- Known primary immunodeficiency or bone marrow failure syndrome
- Atrial fibrillation or flutter (except isolated medically managed episodes)
- Significant pericardial effusion
- Myocardial infarction within the last 12 months
- QT interval corrected for heart rate greater than 480 milliseconds
- Cardiac dysfunction classified as NYHA class III or IV
- Autoimmune disorders requiring systemic immunosuppressive therapy that cannot be safely stopped for 3 months
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
C
Cell Therapy Intake Team
CONTACT
M
Melissa S Varghese, M.S.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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