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RecruitingPriority 3 · Moderate priorityNCT06420076

Sequential CAR-T Cells Therapy for CD5/CD7 Positive T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Using CD5/CD7-Specific CAR-T Cells

ClinicalTrials.gov

Plain-language summary

This trial is testing CD30-directed CAR-T cell therapy (patient's own T cells engineered to attack CD30 on lymphoma cells) for patients with T-cell prolymphocytic leukemia (T-PLL) whose disease has come back or stopped responding to prior treatment. This is a Phase 1/2 trial, which means researchers are determining the best dose and getting early information about effectiveness. This trial does not currently have sites in the United States. The trial is currently recruiting patients.

Who can join (key eligibility)

  • Age 2 Years to 90 Years years
  • Lymphoma came back or did not respond to prior treatment
  • Must be well enough for treatment (adequate performance status)

Final eligibility is determined by the trial team. This list is a starting point only.

What's being tested

CD5/CD7 CAR-T (BIOLOGICAL): The intervention in this clinical trial involves a novel approach using CD5/CD7 Chimeric Antigen Receptor T (CAR T) cells combined with chemotherapy. The goal is to assess safety and efficacy in patients with specific hematologic malignancies. Treatment Regimen: Patients in the trial will undergo the following regimen: Fludarabine Phosphate (Days -4 to -2): IV administration of fludarabine phosphate over 30 minutes on days -4 to -2. It's part of the preparatory regimen to enhance the body's response to CAR T-cell therapy. Cyclophosphamide (Day -2): IV cyclophosphamide over 60 minutes on day -2. CD5/CD7 Chimeric Antigen Receptor T Cells (Day 0): IV administration of investigational therapy, CD5/CD7 CAR T cells, over 10-20 minutes on day 0. Additional Doses: Eligible patients responding well to the initial CD5/CD7 CAR-T cell infusion without unacceptable side effects and sufficient CAR-T cell availability may receive 2 or 3 additional doses.

  • CD5/CD7 CAR-T

Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details

Learn more

What is T-PLL?

Plain-language overview of T-PLL plus all curated trials for this subtype.

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TrialCompass — Clinical Trial Summary

Sequential CAR-T Cells Therapy for CD5/CD7 Positive T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Using CD5/CD7-Specific CAR-T Cells

NCT06420076

Phase: Phase 1, Phase 2 | Status: Recruiting | Priority: Medium

Plain-language summary

This trial is testing CD30-directed CAR-T cell therapy (patient's own T cells engineered to attack CD30 on lymphoma cells) for patients with T-cell prolymphocytic leukemia (T-PLL) whose disease has come back or stopped responding to prior treatment. This is a Phase 1/2 trial, which means researchers are determining the best dose and getting early information about effectiveness. This trial does not currently have sites in the United States. The trial is currently recruiting patients.

Who can join

  • Age 2 Years to 90 Years years
  • Lymphoma came back or did not respond to prior treatment
  • Must be well enough for treatment (adequate performance status)

What's being tested

CD5/CD7 CAR-T (BIOLOGICAL): The intervention in this clinical trial involves a novel approach using CD5/CD7 Chimeric Antigen Receptor T (CAR T) cells combined with chemotherapy. The goal is to assess safety and efficacy in patients with specific hematologic malignancies. Treatment Regimen: Patients in the trial will undergo the following regimen: Fludarabine Phosphate (Days -4 to -2): IV administration of fludarabine phosphate over 30 minutes on days -4 to -2. It's part of the preparatory regimen to enhance the body's response to CAR T-cell therapy. Cyclophosphamide (Day -2): IV cyclophosphamide over 60 minutes on day -2. CD5/CD7 Chimeric Antigen Receptor T Cells (Day 0): IV administration of investigational therapy, CD5/CD7 CAR T cells, over 10-20 minutes on day 0. Additional Doses: Eligible patients responding well to the initial CD5/CD7 CAR-T cell infusion without unacceptable side effects and sufficient CAR-T cell availability may receive 2 or 3 additional doses.

Drugs / treatments: CD5/CD7 CAR-T

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Non-randomized, open-label

Enrollment target: 60 patients

Primary endpoint: The number and incidence of adverse events after CD7/CD5 CAR infusion.; Disease response to CD7/CD5 CAR T cells

Ages: 2 Years to 90 Years

Start date: 2024-07-10 | Est. completion: 2026-12-28

Locations

0 US sites · 1 total

Contact

Rhoda M Smith, Phd | clinical-trials@essen-biotech.com | +12077706670

Sponsor: Essen Biotech (OTHER)

Tags

T-PLL · Relapsed/Refractory

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT06420076

Prepared using TrialCompass (trialcompass.com) on August 3, 2026. For informational purposes only. Always discuss with your healthcare team.