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Phase 1, Phase 2RecruitingPriority 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 Phase 1, Phase 2 trial is testing CD5/CD7 CAR-T for people whose T-cell lymphoma has come back or has not responded to previous treatment. The study starts with lower doses to find the safest effective dose before testing in more people. This trial does not currently list US sites.

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.

Drugs / treatments
CD5/CD7 CAR-T
Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details

At a glance

Phase
Phase 1, Phase 2
Status
Recruiting
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

No US sites currently listed.

Contact

Sponsor
Essen Biotech (OTHER)
Contact
Rhoda M Smith, Phd | clinical-trials@essen-biotech.com | +12077706670

Tags

All T-cell lymphomasMaintenanceRelapsed/Refractory
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 Phase 1, Phase 2 trial is testing CD5/CD7 CAR-T for people whose T-cell lymphoma has come back or has not responded to previous treatment. The study starts with lower doses to find the safest effective dose before testing in more people. This trial does not currently list US sites.

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

All T-cell lymphomas · Maintenance · Relapsed/Refractory

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT06420076

Prepared using TrialCompass (trialcompass.com) on June 19, 2026. For informational purposes only. Always discuss with your healthcare team.
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Data sourced from ClinicalTrials.gov.

For informational purposes only. Not medical advice — always consult your healthcare team.

Built with care for the rare cancer community.

Data last updated: June 2026

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