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NCT06705530
A Study to Evaluate the Tolerability, Safety, and Efficacy of an Anti-CD19 CAR-T Product in Patients With B-cell Lymphoproliferative Disorders
Phase 1, PHASE2 trial testing Hem101 in Non-Hodgkin Lymphoma, B-cell in 58 participants. Completed in 17 November 2025.
17 October 2025
Quick facts
| Lead sponsor | National Research Center for Hematology, Russia |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 58 |
| Start date | 26 November 2024 |
| Primary completion | 17 October 2025 |
| Estimated completion | 17 November 2025 |
| Sites | 1 location across Russia |
Drugs / interventions tested
- Hem101 — full drug profile →
Conditions studied
- Non-Hodgkin Lymphoma, B-cell — all drugs for Non-Hodgkin Lymphoma, B-cell →
- Acute Lymphoblastic Leukemia ALL — all drugs for Acute Lymphoblastic Leukemia ALL →
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:
- PubMed search for NCT06705530
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Non-Hodgkin Lymphoma, B-cell
Currently open trials in the same condition.
- NCT06213636 — Fourth-gen CAR T Cells Targeting CD19/CD22 for Highly Resistant B-cell Lymphoma/Leukemia (PMBCL/CNS-BCL). · Phase 1, PHASE2 · recruiting
- NCT06446128 — A Dose Escalating Study of CD19/CD22/BCMA CAR-T Therapy in Relapsed or Refractory B Cell Non-Hodgkin Lymphoma(NHL) · EARLY_PHASE1 · recruiting
Other National Research Center for Hematology, Russia trials
Trials by the same sponsor.
- NCT06721598 — An Extension Study to Evaluate the Safety and Efficacy of an Anti-CD19 CAR-T Product in Patients with B-cell Lymphoproli · not yet recruiting
- NCT06237192 — MRD-associated Non-intensive But Non-interruptive Treatment of Ph-negative Acute Lymphoblastic Leukemia Adult Patients · NA · recruiting
- NCT06188676 — Multicenter Study of Safety and Efficacy Nivolumab at the Fixed Dose 40 mg (Nivo40) in Combination With Chemo-Immunother · Phase 3 · recruiting
- NCT05158608 — Comparison of PT-Cy at a Dose of 25 mg/kg/Day and PT-Cy at a Dose of 50 mg/kg/Day in GVHD Prophylaxis · Phase 3 · unknown
- NCT05165719 — Validation of 'Corona-T-test' for Assessment of SARS-COV-2-specific T-cell Response After COVID-19 or Vaccination · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06705530 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Research Center for Hematology, Russia
- Last refreshed: 9 February 2026
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