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CD56-Enriched Donor Lymphocyte Infusion

Phase 1

Multiple Myeloma | Monoclonal antibody | Oncology |Teva Pharmaceutical Industries Limited|Last Updated: Nov 12, 2024

Success Probability

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Market & Valuation

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Trial Design

NO_TREATMENT_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

CD56-Enriched Donor Lymphocyte Infusion · 1 trial · 5 indications

Phase 1 1
NCT03524235Haploidentical Stem Cell Transplant with Prophylactic Natural Killer DLI for Lymphoma, Multiple Myeloma, and CLLMultiple Myeloma
COMPLETED20 Analytics
PHASE1COMPLETED
Haploidentical Stem Cell Transplant with Prophylactic Natural Killer DLI for Lymphoma, Multiple Myeloma, and CLL
Multiple MyelomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Rate of Survival at 30 days post -transplantation
30 Days

Proportion of patients undergoing BFR-TBI conditioning + haploidentical alloHSCT alive at 30 days post-transplantation.

Secondary Endpoints

Rate of neutrophil engraftment at 30 days
30 days
Rate of platelet recovery at 100 days post-transplantation
100 days
Rate of severe chronic GVHD at 365 days post-transplantation
365 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SubjectsEXPERIMENTALPre-Transplantation Conditioning (Bendamustine, Fludarabine, and Rituximab + Total Body Irradiation) + Haploidentical Stem Cell Transplantation with CD56-enriched donor lymphocyte infusion
ControlsNO_INTERVENTIONPatients undergoing standard-of-care reduced-intensity peripheral blood allogeneic stem cell transplantation (any indication, donor source, conditioning regimen) using PTCy GVHD prophylaxis.

Interventions

NameTypeDescription
Total Body IrradiationRADIATIONPre-Transplantation Total Body Irradiation
Haploidentical Stem Cell TransplantationPROCEDUREHaploidentical Stem Cell Transplantation
CD56-Enriched Donor Lymphocyte InfusionBIOLOGICALCD56-Enriched Donor Lymphocyte Infusion
BendamustineDRUGPre-Transplantation Bendamustine
FludarabineDRUGPre-Transplantation Fludarabine
RituximabDRUGPre-Transplantation Rituximab (Rituximab for lymphoma diagnosis only)
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

General Inclusion Criteria (For Treatment Groups) * Patient age 18 - 75 years * ECOG 0 - 2 * HIV-positive patients are allowed if these criteria are met: 1. No history of opportunistic infections 2. CD4+ cell count greater or equal to 250 cells/mm3 3. No history of non-malignancy AIDS-defini...

Countries:United States
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Competitive Landscape -Multiple Myeloma 221 trials

Top 20 of 25 competitors

CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV16PHASE3Pomalidomide, Dexamethasone, Venetoclax
Bristol-Myers Squibb CompanyBMY18PHASE3Iberdomide, Lenalidomide
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE3IGI, 10%
GSK plc Sponsored ADRGSK17PHASE3Belantamab mafodotin, Pomalidomide, Dexamethasone, Bortezomib
Johnson & JohnsonJNJ28PHASE3Talquetamab, Pomalidomide, Teclistamab, Elotuzumab, Dexamethasone
Regeneron Pharmaceuticals, Inc.REGN11PHASE3Linvoseltamab, Carfilzomib, Daratumumab, Dexamethasone, Pomalidomide
Pfizer Inc.PFE11PHASE3Elranatamab, Lenalidomide
Sanofi SA Sponsored ADRSNY17PHASE3Isatuximab, Dexamethasone, Pomalidomide, Montelukast, Paracetamol/ Acetaminophen
AstraZeneca PLCAZN5PHASE3AZD0120, Daratumumab, Carfilzomib, Dexamethasone, Bortezomib
Gilead Sciences, Inc.GILD3PHASE3Anitocabtagene Autoleucel, Cyclophosphamide, Fludarabine, Pomalidomide, Bortezomib
Karyopharm Therapeutics, Inc.KPTI6PHASE3Selinexor, Elotuzumab, Pomalidomide, Dexamethasone
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
BioLineRX Ltd. Sponsored ADRBLRX1PHASE3BL-8040/kg, G-CSF
C4 Therapeutics, Inc.CCCC3PHASE2Cemsidomide, Dexamethasone
Cellectar Biosciences, Inc.CLRB1PHASE2Iopofosine I 131 single dose, Iopofosine I 131 fractionated dose
GeoVax Labs, Inc.GOVX1PHASE2COVID-19 Vaccine, Synthetic MVA-based SARS-CoV-2 Vaccine GEO-CM04S1
Autolus Therapeutics Plc Sponsored ADRAUTL1PHASE2AUTO CAR T cell therapy
Incyte CorporationINCY2PHASE1Ruxolitinib, Lenalidomide, Methylprednisolone
Moderna, Inc.MRNA2PHASE1mRNA-2808
BeOne Medicines Ltd. Sponsored ADRONC1PHASE1Sonrotoclax, Dexamethasone, Carfilzomib, Daratumumab, Pomalidomide
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Frequently asked questions about CD56-Enriched Donor Lymphocyte Infusion

What is CD56-Enriched Donor Lymphocyte Infusion used for?

CD56-Enriched Donor Lymphocyte Infusion is an investigational cell therapy being studied for use in multiple myeloma, as well as other blood cancers such as chronic lymphocytic leukemia, lymphoma, and Hodgkin lymphoma. It is administered as a prophylactic treatment following a haploidentical stem cell transplant.

Who is developing CD56-Enriched Donor Lymphocyte Infusion?

CD56-Enriched Donor Lymphocyte Infusion is being developed by Teva Pharmaceutical Industries Limited, which trades on the New York Stock Exchange under the ticker TEVA. The company is conducting clinical research on this investigational therapy for oncology indications.

What phase is CD56-Enriched Donor Lymphocyte Infusion in?

CD56-Enriched Donor Lymphocyte Infusion is in Phase 1 clinical development. It is an investigational therapy and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the therapy is not currently in active clinical trials.

What clinical trials is CD56-Enriched Donor Lymphocyte Infusion in?

CD56-Enriched Donor Lymphocyte Infusion has been studied in one completed clinical trial, identified as NCT03524235. This Phase 1 trial, titled 'Haploidentical Stem Cell Transplant with Prophylactic Natural Killer DLI for Lymphoma, Multiple Myeloma, and CLL,' enrolled 20 participants in the United States.

Is CD56-Enriched Donor Lymphocyte Infusion the same as natural killer cell therapy?

CD56-Enriched Donor Lymphocyte Infusion is a type of donor lymphocyte infusion enriched for CD56-positive cells, which include natural killer cells. The clinical trial NCT03524235 describes it as a prophylactic natural killer DLI, indicating it is a natural killer cell-based therapy.