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CD70 Targeted CAR-T Cells in CD70 Positive Relapsed/Refractory Lymphoma

NCT05948033 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-07-17

No results posted yet for this study

Summary

In this single-center, single-arm,prospective, open-label, phase 1/2 study, the safety and efficacy of autologous CD70 targeted chimeric antigen receptor modified T (CAR-T) cell therapy will be evaluated in patients with CD70 antigen positive Relapsed/Refractory Lymphoma . In this clinical trial, at least 12 eligible patients in dose escalation period will be enrolled to receive 3 doses of CD70-CAR cell therapy according to the "3+3" principle. In dose expansion period, additional at most 21 eligible patients will be enrolled to receive CD70-CAR-T cell therapy at dose of recommended phase 2 dose(RP2D).

Conditions

Interventions

BIOLOGICAL

CD70-targeting CAR-T cells

Dose escalation: Dose1 (1×10\^6 cells/kg) ,Dose 2(3×10\^6 cells/kg) ,Dose 3 (1×10\^7 cells/kg) Doseexpansion: RP2D Drug: Fludarabine Intravenous fludarabine 25-30 mg/m\^2/day on days 5, -4, and -3. Drug: Cyclophosphamide Intravenous cyclophosphamide 300-500 mg/m\^2/day on days -5, -4, and -3.

Sponsors & Collaborators

  • UTC Therapeutics Inc.

    collaborator INDUSTRY

  • Chinese PLA General Hospital

    lead OTHER

Principal Investigators

  • Yangbin Zhao, Ph.D · UTC Therapeutics Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-15
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05948033 on ClinicalTrials.gov