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A Study to Evaluate the Tolerability, Safety, and Efficacy of an Anti-CD19 CAR-T Product in Patients With B-cell Lymphoproliferative Disorders

NCT06705530 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2026-02-09

No results posted yet for this study

Summary

This study is testing a new type of treatment called anti-CD19 CAR-T cell therapy for adults with certain blood cancers that have returned or did not respond to previous treatments. CAR-T cells are a type of immune cell that is specially designed in a lab to target and destroy cancer cells with a marker called CD19. The main goals of this study are to find out if this treatment is safe, how well patients tolerate it, and how effective it is at controlling cancer.

The study will include 60 adults, ages 18-70, who meet specific criteria for participation. Patients will first receive a short course of chemotherapy to prepare their bodies for the CAR-T cells. The CAR-T cells will then be given in two doses through an IV. Patients will be monitored closely in the hospital for about a month to check for any side effects and see how their cancer responds. The researchers will also follow up with patients over time to learn more about how long the CAR-T cells stay active, how well they fight cancer, and the overall health of the patients after treatment.

Conditions

  • Non-Hodgkin Lymphoma, B-cell
  • Acute Lymphoblastic Leukemia ALL

Interventions

BIOLOGICAL

Hem101

CAR-T lymphocytes specific to CD19 B-cell antigen

Sponsors & Collaborators

  • National Research Center for Hematology, Russia

    lead NETWORK

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-11-26
Primary Completion
2025-10-17
Completion
2025-11-17

Countries

  • Russia

Study Locations

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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 NCT06705530 on ClinicalTrials.gov