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RecruitingPriority 3 · Moderate priorityNCT06911710

The Application of CAR-T Cell Therapy in Relapsed and Refractory Malignant Hematologic Tumors

ClinicalTrials.gov

Plain-language summary

This Phase 1, Phase 2 trial is testing CAR-T Cells infusion(CAR2219, CAR2019, and other medications 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 18 Years or older
  • Lymphoma came back or did not respond to prior treatment
  • Must be well enough for treatment (adequate performance status)
  • May require specific number of prior treatments

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

What's being tested

CAR-T Cells infusion(CAR2219,CAR2019, CAR19 etc) (DRUG): Phase I study: dose-escalation component.This part follows the "3+3" dose-escalation model, with 5 dose groups: 1×10\^6, 1.5×10\^6, 2×10\^6, 2.5×10\^6, 3×10\^6 CAR+ cells/kg (different target CAR-T can be adjusted by the investigator according to the dose used in the previous clinical trial). Each dose group enrolled 3\~6 patients with relapsed/refractory hematological diseases respectively, totaling 15\~30 subjects, in order to evaluate the safety of CAR-T cells for the treatment of relapsed/refractory malignant hematological neoplasms and to determine the MTD. Phase II study: dose-expansion portion. After the MTD was confirmed, in the dose-expansion portion of the study (Phase II), it was expected that 65\~60 subjects would receive the CAR-T cell injection infusion under RP2D to further evaluate the efficacy of CAR-T cell injection.

Drugs / treatments
CAR-T Cells infusion(CAR2219,CAR2019, CAR19 etc)
Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details

At a glance

Phase
Not applicable
Status
Recruiting
Design
Non-randomized, open-label
Enrollment target
90 patients
Primary endpoint
The incidence of adverse events
Ages
18 Years to —
Start date
2024-11-09
Est. completion
2027-02-28

Locations

0 US sites · 1 total

No US sites currently listed.

Contact

Sponsor
Tianjin Medical University General Hospital (OTHER)
Contact
Rong Fu | yhwhao@126.com | +86 12260817111

Tags

All T-cell lymphomasRelapsed/Refractory
TrialCompass — Clinical Trial Summary

The Application of CAR-T Cell Therapy in Relapsed and Refractory Malignant Hematologic Tumors

NCT06911710

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

Plain-language summary

This Phase 1, Phase 2 trial is testing CAR-T Cells infusion(CAR2219, CAR2019, and other medications 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 18 Years or older
  • Lymphoma came back or did not respond to prior treatment
  • Must be well enough for treatment (adequate performance status)
  • May require specific number of prior treatments

What's being tested

CAR-T Cells infusion(CAR2219,CAR2019, CAR19 etc) (DRUG): Phase I study: dose-escalation component.This part follows the "3+3" dose-escalation model, with 5 dose groups: 1×10\^6, 1.5×10\^6, 2×10\^6, 2.5×10\^6, 3×10\^6 CAR+ cells/kg (different target CAR-T can be adjusted by the investigator according to the dose used in the previous clinical trial). Each dose group enrolled 3\~6 patients with relapsed/refractory hematological diseases respectively, totaling 15\~30 subjects, in order to evaluate the safety of CAR-T cells for the treatment of relapsed/refractory malignant hematological neoplasms and to determine the MTD. Phase II study: dose-expansion portion. After the MTD was confirmed, in the dose-expansion portion of the study (Phase II), it was expected that 65\~60 subjects would receive the CAR-T cell injection infusion under RP2D to further evaluate the efficacy of CAR-T cell injection.

Drugs / treatments: CAR-T Cells infusion(CAR2219,CAR2019, CAR19 etc)

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Non-randomized, open-label

Enrollment target: 90 patients

Primary endpoint: The incidence of adverse events

Ages: 18 Years to —

Start date: 2024-11-09 | Est. completion: 2027-02-28

Locations

0 US sites · 1 total

Contact

Rong Fu | yhwhao@126.com | +86 12260817111

Sponsor: Tianjin Medical University General Hospital (OTHER)

Tags

All T-cell lymphomas · Relapsed/Refractory

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT06911710

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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