A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma (DURGA-4)

Last updated: March 11, 2026
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

3

Condition

Cancer/tumors

Platelet Disorders

Leukemia

Treatment

Pomalidomide

Dexamethasone

Daratumumab

Clinical Study ID

NCT07391657
D8311C00001
AZD0120
  • Ages > 18
  • All Genders

Study Summary

This is a randomised, multicentre, controlled, open-label, Phase III global study comparing the efficacy and safety of AZD0120 versus standard regimens (DKd [daratumumab, carfilzomib, and dexamethasone], DPd [daratumumab, pomalidomide, and dexamethasone], PVd [pomalidomide, bortezomib and dexamethasone], or Kd [carfilzomib and dexamethasone]) in participants with RRMM.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years

  • Documented diagnosis of multiple myeloma according to the IMWG diagnostic criteria

  • Documented evidence of measurable disease:

  1. Serum M-protein level ≥ 1 g/dL

  2. Urine M-protein level ≥ 200 mg/24h

  3. Serum immunoglobulin free light chain ≥ 10 mg/dL (100 mg/L) and abnormal serumimmunoglobulin kappa lambda free light chain ratio

  • Documented evidence of PD by IMWG 2016 criteria based on investigator'sdetermination during or after the most recent line of therapy. Participants withonly 1 prior line of therapy must have progressed within 47 months of a stem celltransplant, or if not transplanted, then within 42 months of starting initialtherapy

  • Received 1 to 3 lines of prior therapy including an IMiD and either a PI or a CD38antibody. Participant must have undergone at least 2 complete cycles of treatmentfor each line of therapy, unless PD was the best response to the line of therapy

  • Eligible to receive at least one of the standard regimens (DKd, PVd, DPd, or Kd) asdetermined by the Investigator.

  • ECOG performance status score of 0 to 1

  • Adequate hematology and chemistry laboratory values:

  1. Haemoglobin ≥ 8.0 g/dL

  2. Absolute neutrophil count ≥ 1 × 10^9/L (1000 per mm3)

  3. Platelet count ≥ 75 × 10^9/L (75000 per mm3) in participants with < 50% of bonemarrow nucleated cells are plasma cells or ≥ 50 × 10^9/L (50000 per mm3) inparticipants with ≥ 50% of bone marrow nucleated cells are plasma cells

  4. Absolute lymphocyte count ≥ 300/µL (0.3 × 109/L)

  5. Total bilirubin ≤ 1.5 × ULN in the absence of Gilbert's syndrome or ≤ 3 × ULNif the participant has Gilbert's syndrome. AST and ALT≤ 3.0 × ULN. CrCl byCockcroft and Gault method ≥ 30 mL/minute

Exclusion

Exclusion Criteria:

  • Known active, or prior history of CNS involvement or exhibits clinical signs ofmeningeal involvement of MM.

  • Primary amyloidosis, active plasma cell leukaemia, Waldenstrom macroglobulinemia orPolyneuropathy Organomegaly Endocrinopathy M-protein and Skin (POEMS) syndrome.

  • Participants with primary refractory MM (failed to generate at least a minimalresponse to any prior therapy)

  • Significant neurological or psychiatric condition

  • Significant medical condition that places the participant at an unacceptable riskfor treatment-related complications

  • Previously received any prior BCMA-targeted treatment

  • Previously received CAR-T or CAR-NK therapy directed at any target

  • Previously received T-cell engager therapy directed at any target

  • Previously received allogeneic stem cell transplantation at any time during priortherapy or received autologous stem cell transplantation within 12 weeks ofrandomization

Study Design

Total Participants: 508
Treatment Group(s): 6
Primary Treatment: Pomalidomide
Phase: 3
Study Start date:
February 23, 2026
Estimated Completion Date:
July 29, 2030

Connect with a study center

  • Research Site

    Camperdown, 2050
    Australia

    Site Not Available

  • Research Site

    Camperdown 2172563, 2050
    Australia

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  • Research Site

    Darlinghurst, 2010
    Australia

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    Darlinghurst 2169378, 2010
    Australia

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    Fitzroy, VIC3065
    Australia

    Active - Recruiting

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    Fitzroy 2166584, VIC3065
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    Liverpool, 2170
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    Liverpool 2159851, 2170
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    Melbourne, 3004
    Australia

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    Melbourne 2158177, 3000
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    Murdoch, WA6150
    Australia

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    Murdoch 8349091, WA6150
    Australia

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    Salvador, 41253-190
    Brazil

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    Salvador 3450554, 41253-190
    Brazil

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    São Paulo, 05652-900
    Brazil

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    São Paulo 3448439, 01509-900
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    Calgary, Alberta T2N 5G2
    Canada

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    Calgary 5913490, Alberta 5883102 T2N 5G2
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    Vancouver, British Columbia V5Z 4E6
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    Vancouver 6173331, British Columbia 5909050 V5Z 4E6
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    Toronto, Ontario M5G 2M9
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    Toronto 6167865, Ontario 6093943 M5G 2M9
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    Montreal, Quebec H3A 1A1
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    Montreal 6077243, Quebec 6115047 H3A 1A1
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    Lille, 59037
    France

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    Lille 2998324, 59037
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    Nantes, 44093
    France

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    Nantes 2990969, 44093
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    Paris, 75010
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    Paris 2988507, 75010
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    Pierre-Bénite, 69495
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    Pierre-Bénite 2987314, 69495
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    Poitiers, 86021
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    Poitiers 2986495, 86021
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    Toulouse, 31059
    France

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    Toulouse 2972315, 31059
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    Berlin, 12200
    Germany

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    Berlin 2950159, 12200
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    Dresden, 01307
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    Dresden 2935022, 01307
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    Erlangen, 91054
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    Erlangen 2929567, 91054
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    Essen, 45147
    Germany

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    Essen 2928810, 45147
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    Freiburg im Breisgau, 79106
    Germany

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    Freiburg im Breisgau 2925177, 79106
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    Hamburg, 20246
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    Hamburg 2911298, 20246
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    Leipzig, 04103
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    Leipzig 2879139, 04103
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    Mainz, 55131
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    Mainz 2874225, 55131
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    Nuremberg, 90419
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    Nuremberg 2861650, 90419
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    Würzburg, 97080
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    Würzburg 2805615, 97080
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    Bologna, 40138
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    Bologna 3181928, 40138
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    Milan, 20132
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    Milan 6951411, 20132
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    Napoli, 80131
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    Napoli 9031661, 80131
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    Rozzano, 20089
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    Rozzano 3168837, 20089
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    Torino, 10126
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    Torino 8980539, 10126
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    Bunkyō City, 113-8431
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    Bunkyō City 11790632, 113-8431
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    Kashiwa, 277-8577
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    Kashiwa 1859924, 277-8577
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    Kyoto, 602-8566
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    Kyoto 1857910, 602-8566
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    Nagoya, 467-8602
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    Nagoya 1856057, 467-8602
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    Shibuya-ku, 150-8935
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    Shinjuku-ku, 160-8582
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    Oslo, 0450
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    Gdansk, 80-952
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    Gdansk 3099434, 80-952
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    Gliwice, 44-101
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    Gliwice 3099230, 44-101
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    Lublin, 20-090
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    Lublin 765876, 20-090
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    Poznan, 60-569
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    Poznan 3088171, 60-569
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    Warsaw, 02-776
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    Warsaw 756135, 02-776
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    Wroclaw, 50-367
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    Wroclaw 3081368, 50-367
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    Seoul, 06351
    South Korea

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    Seoul 1835848, 03080
    South Korea

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    Barcelona, 8035
    Spain

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    Barcelona 3128760, 08036
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    Madrid, 28041
    Spain

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    Madrid 3117735, 28041
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    Pamplona, 31008
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    Pamplona 3114472, 31008
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    Salamanca, 37007
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    Salamanca 3111108, 37007
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    Santander, 39008
    Spain

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    Santander 3109718, 39008
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    Valencia, 46026
    Spain

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    Valencia 2509954, 46026
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    Taipei, 106
    Taiwan

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    Taipei 1668341, 112
    Taiwan

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    Birmingham, B9 5SS
    United Kingdom

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    Birmingham 2655603, B9 5SS
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    Bristol, BS2 8ED
    United Kingdom

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    Bristol 2654675, BS2 8ED
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    Glasgow, Scotland, G12 0YN
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    London, SM2 5NG
    United Kingdom

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    London 2643743, SM2 5NG
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    Gilbert, Arizona 85234
    United States

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    Phoenix, Arizona 85054
    United States

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    Tucson, Arizona 85719
    United States

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    Gilbert 5295903, Arizona 5551752 85234
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    Phoenix 5308655, Arizona 5551752 85054
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    Tucson 5318313, Arizona 5551752 85719
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    La Jolla, California 92093
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    Santa Monica, California 90404
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    La Jolla 5363943, California 5332921 92093
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    Santa Monica 5393212, California 5332921 90404
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    Denver, Colorado 80218
    United States

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    Denver 5419384, Colorado 5417618 80218
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    New Haven, Connecticut 06510
    United States

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    New Haven 4839366, Connecticut 4831725 06510
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    Washington D.C., District of Columbia 20007
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    Washington D.C. 4140963, District of Columbia 4138106 20007
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    Atlanta, Georgia 30322
    United States

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    Atlanta 4180439, Georgia 4197000 30322
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    Chicago, Illinois 60612
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    Park Ridge, Illinois 60068
    United States

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    Chicago 4887398, Illinois 4896861 60612
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    Park Ridge 4905367, Illinois 4896861 60068
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    Iowa City, Iowa 52242
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    Iowa City 4862034, Iowa 4862182 52242
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    Kansas City, Kansas 66160
    United States

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    Kansas City 4273837, Kansas 4273857 66160
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    Louisville, Kentucky 40207
    United States

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    Louisville 4299276, Kentucky 6254925 40207
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    Boston, Massachusetts 02215
    United States

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    Boston 4930956, Massachusetts 6254926 02114
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    Detroit, Michigan 48202
    United States

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    Detroit 4990729, Michigan 5001836 48202
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    Rochester, Minnesota 55905
    United States

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    Rochester 5043473, Minnesota 5037779 55905
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    New York, New York 10016
    United States

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    The Bronx, New York 10467
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  • Research Site

    New York 5128581, New York 5128638 10065
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    Rochester 5134086, New York 5128638 14642
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    The Bronx 5110266, New York 5128638 10467
    United States

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    Chapel Hill, North Carolina 27514
    United States

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  • Research Site

    Charlotte, North Carolina 28204
    United States

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    Winston-Salem, North Carolina 27103
    United States

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  • Research Site

    Chapel Hill 4460162, North Carolina 4482348 27514
    United States

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  • Research Site

    Charlotte 4460243, North Carolina 4482348 28204
    United States

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  • Research Site

    Winston-Salem 4499612, North Carolina 4482348 27103
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    Cincinnati, Ohio 45220
    United States

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  • Research Site

    Cleveland, Ohio 44195
    United States

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  • Research Site

    Cincinnati 4508722, Ohio 5165418 45220
    United States

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  • Research Site

    Cleveland 5150529, Ohio 5165418 44195
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    Portland, Oregon 97239
    United States

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  • Research Site

    Portland 5746545, Oregon 5744337 97239
    United States

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    Charleston, South Carolina 29425
    United States

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  • Research Site

    Charleston 4574324, South Carolina 4597040 29425
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    Nashville, Tennessee 37203
    United States

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  • Research Site

    Nashville 4644585, Tennessee 4662168 37203
    United States

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  • Research Site

    Austin, Texas 78704
    United States

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  • Research Site

    Dallas, Texas 75235
    United States

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    Houston, Texas 77030
    United States

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  • Research Site

    Austin 4671654, Texas 4736286 78704
    United States

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  • Research Site

    Dallas 4684888, Texas 4736286 75235
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  • Research Site

    Houston 4699066, Texas 4736286 77030
    United States

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    Salt Lake City, Utah 84112
    United States

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  • Research Site

    Salt Lake City 5780993, Utah 5549030 84112
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    Charlottesville, Virginia 22908
    United States

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    Richmond, Virginia 23298
    United States

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    Charlottesville 4752031, Virginia 6254928 22908
    United States

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  • Research Site

    Richmond 4781708, Virginia 6254928 23298
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    Seattle, Washington 98104
    United States

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  • Research Site

    Seattle 5809844, Washington 5815135 98104
    United States

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    Madison, Wisconsin 53792
    United States

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  • Research Site

    Milwaukee, Wisconsin 53226
    United States

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  • Research Site

    Madison 5261457, Wisconsin 5279468 53792
    United States

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  • Research Site

    Milwaukee 5263045, Wisconsin 5279468 53226
    United States

    Site Not Available

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