Anti-CD7 CAR-T Cells in Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia or Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age0-29
SponsorStephan Grupp MD PhD
About this trial
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.
Eligibility criteria
Qualifiers
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.
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
Disqualifiers
Active hepatitis B or active hepatitis C
Active HTLV infection
HIV infection
Uncontrolled, active bacterial, viral, or fungal infection.
Trial design
Treatments tested in this trial
- Allogeneic anti-CD7 CAR-T cells (BEAM-201)
Treatment groups
33 Participants
are divided into 2 treatment groupsSponsors and collaborators
Stephan Grupp MD PhD
Lead sponsor
Children's Hospital of Philadelphia
Sponsor institution
Beam Therapeutics Inc.
Collaborator
Source ClinicalTrials.gov