Skip to content
DataLookout
Start free
Menu

24CT015NCT06934382

Anti-CD7 CAR-T Cells in Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia or Lymphoma

StatusActive, Not Recruiting
PhasePhase 1
Primary completion (estimated)
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 8 versions: 7 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 43 words
    • Enrollment closed, study ongoing
    • Study description revised
    • Site details revised
  2. Site contact updatedv7
  3. Eligibility criteria shortened, about 2 words
    • Site contact updated
    v6
  4. Eligibility criteria expanded, about 20 wordsv5
  5. Eligibility criteria shortened, about 18 wordsv4
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 1, 2025 to Apr 29, 2025
    • Site details revised
    • Study description expanded, about 1 word
    v2
  7. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Determine the Maximum Tolerate Dose of Beam 201 Cells
Timeframe: 5 years
Frequency of Adverse Events Following Beam-201 administration
Timeframe: 5 years

Secondary (5)

• Determine the overall response rate following BEAM-201 infusion
Determine depth of response based on MRD for patients with clinical responses following BEAM-201 infusion
Determine the proportion of patients treated with BEAM-201 who are deemed appropriate for stem cell transplant
• Determine duration of response for patients with clinical responses following BEAM 201 infusion
Determine overall survival following BEAM-201 infusion

Arms and interventions

Dose Escalation ArmExperimental

The dose escalation portion of the trial will use a standard "3+3" design to establish the recommended maximum tolerated dose of BEAM-201 cells. Three dose escalations of BEAM-201 are planned for the dose escalation phase, with one dose de-escalation level if needed. Should there be sufficient clinical response at lower doses (i.e. DL1 or DL2), then the sponsor and principal investigator may choose to forgo further dose escalation and proceed to dose expansion at the lower dose level.

Dose Expansion ArmExperimental

If at least one dose level of the dose escalation phase is determined to be safe, the dose expansion phase of the trial will be opened to enrollment.

Biologicals: Allogeneic anti-CD7 CAR-T cells (BEAM-201)

Sites

1 site in 1 country

  • Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania, United States