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NCT03524235
Haploidentical Stem Cell Transplant with Prophylactic Natural Killer DLI for Lymphoma, Multiple Myeloma, and CLL
Phase 1 trial testing Total Body Irradiation in Multiple Myeloma in 20 participants. Completed in 6 November 2024.
7 November 2021
Quick facts
| Lead sponsor | Noah Merin |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 18 July 2018 |
| Primary completion | 7 November 2021 |
| Estimated completion | 6 November 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Total Body Irradiation
- Haploidentical Stem Cell Transplantation — full drug profile →
- CD56-Enriched Donor Lymphocyte Infusion
- Bendamustine (BENDAMUSTINE) — full drug profile →
- Fludarabine (FLUDARABINE) — full drug profile →
- Rituximab — full drug profile →
Conditions studied
- Multiple Myeloma — all drugs for Multiple Myeloma →
- CLL — all drugs for CLL →
- Chronic Lymphocytic Leukemia — all drugs for Chronic Lymphocytic Leukemia →
- Lymphoma — all drugs for Lymphoma →
Sponsor
Noah Merin — full company profile →
Who can join
Adults 18 to 75, any sex, with Multiple Myeloma or CLL. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study seeks to examine the investigational use of the conditioning regimen (bendamustine, fludarabine, and rituximab) prior to haploidentical peripheral blood allogeneic stem cell transplantation with Post-Transplant Cyclophosphamide. The study will also test the investigational use of CD56-enriched Donor Lymphocyte Infusion to see if this treatment is safe, and whether or not it will help patients achieve better outcomes post-transplant, including reduced risk of Graft-Versus-Host Disease (GVHD), and preventing disease relapse.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Natural killer cells in clinical development as non-engineered, engineered, and combination therapies.
Lamers-Kok N, Panella D, Georgoudaki AM, Liu H, et al · · 2022 · cited 125× · PMID 36348457 · DOI 10.1186/s13045-022-01382-5 -
The Future of Natural Killer Cell Immunotherapy for B Cell Non-Hodgkin Lymphoma (B Cell NHL).
Chu Y, Lamb M, Cairo MS, Lee DA. · · 2022 · cited 14× · PMID 35258793 · DOI 10.1007/s11864-021-00932-2 -
Graft-versus-tumor effect of post-transplant cyclophosphamide-based allogeneic hematopoietic cell transplantation.
Nakamae H. · · 2024 · cited 5× · PMID 38903503 · DOI 10.3389/fimmu.2024.1403936 -
Historical Perspective of Allogeneic Hematopoietic Stem Cell Transplantation for Multiple Myeloma.
Aslam MF, Cheema AY, Shahid D, Maryam B, et al · · 2025 · PMID 39586285 · DOI 10.1159/000542704
Verify or expand the search:
- PubMed search for NCT03524235
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Total Body Irradiation
Trials testing the same drug.
- NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting
- NCT07524530 — Stem Cell Transplantation for Participants With Germline RUNX1 Associated Blood Cancers · Phase 2 · not yet recruiting
- NCT07162038 — Phase I Trial Integrating HLA-Haploidentical Anti-CD19 CAR-T Cells With Post-Transplantation Cyclophosphamide-Based HLA- · Phase 1 · recruiting
- NCT07015684 — 131I-apamistamab-based Conditioning for Hematopoietic Stem Cell Transplant (HSCT) in Advanced Sickle Cell Disease (SCD) · Phase 1 · recruiting
- NCT06680661 — ABBA CORD: dCBT w/ Abatacept for aGVHD Prophylaxis · Phase 2 · recruiting
Other recruiting trials for Multiple Myeloma
Currently open trials in the same condition.
- NCT07200102 — Selinexor Maintenance Post CAR-T Cell Therapy for Multiple Myeloma · Phase 1 · recruiting
- NCT07340853 — CRISPR Delivered Anti-BCMA Car-T Therapy for Relapsed or Refractory Multiple Myeloma · Phase 1 · recruiting
- NCT07454382 — A Study of Elranatamab and Cyclophosphamide in People With Multiple Myeloma · Phase 2 · recruiting
- NCT07266441 — A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma · Phase 2 · recruiting
- NCT07258511 — A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With · Phase 3 · recruiting
Other Noah Merin trials
Trials by the same sponsor.
- NCT04353206 — Convalescent Plasma in ICU Patients With COVID-19-induced Respiratory Failure · EARLY_PHASE1 · terminated
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 NCT03524235 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Noah Merin
- Last refreshed: 12 November 2024
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/NCT03524235.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing