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Study to Evaluate the Safety and Efficacy of IM19 CAR-T Cells in Patients With Relapsed and Refractory (R/R) Mantle Cell Lymphoma

NCT05155215 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2021-12-13

No results posted yet for this study

Summary

This is a phase I/II, open-label, multicenter study to assess the efficacy and safety of IM19 CAR-T cells in adult R/R Mantle Cell Lymphoma subjects

Conditions

  • Lymphoma
  • Lymphoma, Mantle-Cell
  • Neoplasms by Histologic Type
  • Neoplasms
  • Lymphoproliferative Disorders

Interventions

BIOLOGICAL

IM19 CAR-T cells

IM19 CAR-T cells will be administered at dose level: 100×10\^6 CAR-T cells or 200×10\^6 CAR-T cells

DRUG

Cyclophosphamide

300 mg/m\^2 per day for 3 days (IV)

DRUG

Fludarabine

30 mg/m\^2 per day for 3 days (IV)

Sponsors & Collaborators

  • Beijing Immunochina Medical Science & Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Hongmei Jing, Ph.D · Peking University Third Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-31
Primary Completion
2022-12-31
Completion
2023-02-28

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Drugs
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 NCT05155215 on ClinicalTrials.gov