Last reviewed · How we verify

NCT06705530

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

Completed Phase 1, PHASE2 Last updated 9 February 2026
What this trial tests

Phase 1, PHASE2 trial testing Hem101 in Non-Hodgkin Lymphoma, B-cell in 58 participants. Completed in 17 November 2025.

Timeline
26 November 2024
Primary endpoint
17 October 2025
17 November 2025

Quick facts

Lead sponsorNational Research Center for Hematology, Russia
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment58
Start date26 November 2024
Primary completion17 October 2025
Estimated completion17 November 2025
Sites1 location across Russia

Drugs / interventions tested

Conditions studied

Sponsor

National Research Center for Hematology, Russia — full company profile →

Who can join

Adults 18 to 70, any sex, with Non-Hodgkin Lymphoma, B-cell or Acute Lymphoblastic Leukemia ALL. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Non-Hodgkin Lymphoma, B-cell

Currently open trials in the same condition.

Other National Research Center for Hematology, Russia trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06705530.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing