To hear about similar clinical trials, please enter your email below
Trial Title:
Phase 1, Open-label, Dose-escalation Trial with CD38-SADA:177 Lu-DOTA Drug Complex in Subjects with Relapsed or Refractory Non-Hodgkin Lymphoma
NCT ID:
NCT05994157
Condition:
Non-hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
CD38-SADA:177Lu-DOTA Complex
Description:
The IMP is a two-step radioimmunotherapy, delivered as two separate products CD38-SADA
and 177Lu-DOTA. Both will be administered as an IV infusions.
Arm group label:
CD38-SADA:177Lu-DOTA Complex
Summary:
Patients with non-Hodgkin Lymphoma will be treated with CD38-SADA:177Lu-DOTA complex (The
IMP is a two-step radioimmunotherapy, delivered as two separate products CD38-SADA and
177Lu-DOTA) to establish optimal and safe therapeutic doses and dosing schedule of
CD38-SADA, and 177Lu-DOTA.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Target population must have relapsed, progressive or refractory non-hodgkin lymphoma
and be ineligible for or have exhausted standard therapeutic options that may
prolong survival
- The subject must have fluoro-deoxyglucose (FDG)-avid lymphoma with measurable
disease
- CD38 positive tumor at most recent biopsy (new or archival) documented at central
laboratory
- Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status
score of 0, 1, or 2
- Each subject must sign an ICF indicating that he or she understands the purpose of,
and procedures required for the trial and is willing to participate in the trial.
Exclusion Criteria:
- Primary central nervous system lymphoma or known central nervous system involvement
with lymphoma
- Systemic chemotherapy, radiotherapy, immunotherapy, or major surgery administered
within 3 weeks (for nitrosoureas within 6 weeks) prior to the first dose of
CD38-SADA
- Radioimmunotherapy within 100 days prior to the first dose of CD38-SADA
- Autologous stem cell transplantation within 42 days prior to the first dose of
CD38-SADA
- Treatment with approved CAR-T within 100 days prior to the first dose of CD38-SADA
- >40% lymphoma bone marrow involvement
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
HonorHealth
Address:
City:
Scottsdale
Zip:
85258
Country:
United States
Status:
Recruiting
Facility:
Name:
City of Hope
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Facility:
Name:
Corewell Health-BAMF Health
Address:
City:
Grand Rapids
Zip:
49503
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Facility:
Name:
Stony Brook Cancer Center
Address:
City:
Stony Brook
Zip:
11794
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
East Carolina University Leo W. Jenkins Cancer Center
Address:
City:
Greenville
Zip:
27834
Country:
United States
Status:
Not yet recruiting
Start date:
October 2024
Completion date:
January 2028
Lead sponsor:
Agency:
Y-mAbs Therapeutics
Agency class:
Industry
Source:
Y-mAbs Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05994157
