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Phase 1RecruitingPriority 2 · High priorityNCT03081910

Autologous T-Cells Expressing a Second Generation CAR for Treatment of T-Cell Malignancies Expressing CD5 Antigen

ClinicalTrials.gov

Plain-language summary

This Phase 1 trial is comparing Autologous CD5.CAR/28zeta CAR T cells and Allogeneic CD5.CAR/28zeta CAR T cells against other options for people whose a type of T-cell lymphoma called AITL has come back or has not responded to previous treatment. Patients are randomly assigned to different treatment groups to see which approach works best. It is available at 2 US locations.

Who can join (key eligibility)

  • Lymphoma came back or did not respond to prior treatment
  • See full trial listing for complete eligibility

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

What's being tested

Autologous CD5.CAR/28zeta CAR T cells (GENETIC): Three dose levels will be evaluated: Dose level one: 1×10\^7 cells/m2 Dose level two: 5×10\^7 cells/m2 Dose level three: 1×10\^8 cells/m2 | Allogeneic CD5.CAR/28zeta CAR T cells (GENETIC): Three dose levels will be evaluated: Dose level one: 1×10\^7 cells/m2 Dose level two: 5×10\^7 cells/m2 Dose level three: 1×10\^8 cells/m2

Drugs / treatments
Autologous CD5.CAR/28zeta CAR T cells, Allogeneic CD5.CAR/28zeta CAR T cells
Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details

At a glance

Phase
Phase 1
Status
Recruiting
Design
Non-randomized, open-label
Enrollment target
54 patients
Primary endpoint
Dose limiting toxicity (DLT) rate
Ages
— to 75 Years
Start date
2017-11-01
Est. completion
2040-09-01

Locations

2 US sites · 2 total

Texas

Contact

Sponsor
Baylor College of Medicine (OTHER)
Contact
Rayne Rouce, MD | rhrouce@texaschildrens.org | 832-824-4716

Tags

AITL/TFHALCLATLLCTCLEATLENKTLMEITLT-PLLRelapsed/Refractory
TrialCompass — Clinical Trial Summary

Autologous T-Cells Expressing a Second Generation CAR for Treatment of T-Cell Malignancies Expressing CD5 Antigen

NCT03081910

Phase: Phase 1 | Status: Recruiting | Priority: High

Plain-language summary

This Phase 1 trial is comparing Autologous CD5.CAR/28zeta CAR T cells and Allogeneic CD5.CAR/28zeta CAR T cells against other options for people whose a type of T-cell lymphoma called AITL has come back or has not responded to previous treatment. Patients are randomly assigned to different treatment groups to see which approach works best. It is available at 2 US locations.

Who can join

  • Lymphoma came back or did not respond to prior treatment
  • See full trial listing for complete eligibility

What's being tested

Autologous CD5.CAR/28zeta CAR T cells (GENETIC): Three dose levels will be evaluated: Dose level one: 1×10\^7 cells/m2 Dose level two: 5×10\^7 cells/m2 Dose level three: 1×10\^8 cells/m2 | Allogeneic CD5.CAR/28zeta CAR T cells (GENETIC): Three dose levels will be evaluated: Dose level one: 1×10\^7 cells/m2 Dose level two: 5×10\^7 cells/m2 Dose level three: 1×10\^8 cells/m2

Drugs / treatments: Autologous CD5.CAR/28zeta CAR T cells, Allogeneic CD5.CAR/28zeta CAR T cells

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Non-randomized, open-label

Enrollment target: 54 patients

Primary endpoint: Dose limiting toxicity (DLT) rate

Ages: — to 75 Years

Start date: 2017-11-01 | Est. completion: 2040-09-01

Locations

2 US sites · 2 total

Texas

Contact

Rayne Rouce, MD | rhrouce@texaschildrens.org | 832-824-4716

Sponsor: Baylor College of Medicine (OTHER)

Tags

AITL/TFH · ALCL · ATLL · CTCL · EATL · ENKTL · MEITL · T-PLL · Relapsed/Refractory

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT03081910

Prepared using TrialCompass (trialcompass.com) on July 4, 2026. For informational purposes only. Always discuss with your healthcare team.
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Data sourced from ClinicalTrials.gov.

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Data last updated: June 2026

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