Clinical trial · Interventional
64Cu-LLP2A for Imaging Hematologic Malignancies
Early Phase I Evaluation of 64Cu-LLP2A for Imaging Hematologic Malignancies Part B
NCT06636175CI-TRIAL-00115118recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase of the protocol (protocol part B), seeks to evaluate the new formulation in healthy normal volunteers to confirm the new formulation provides comparable human dosimetry to which was seen and published in protocol part A. Additionally, the new formulation will be studied utilizing an expanded patient population to include patients with confirmed diagnosis of multiple myeloma (MM), low-grade lymphoma, or MM and lymphoma patients who are status post bone marrow transplant (BMT) with negative imaging and suspected recurrence.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Low-Grade Lymphoma | — | UNRESOLVED | — |
| Lymphoplasmacytic Lymphoma | Lymphoplasmacytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Marginal Zone Lymphoma | Marginal Zone Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 64Cu-LLP2A | Drug | — | UNRESOLVED |
| PET/CT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pilot/Cohort 1B: Dosimetry 64Cu-LLP2A
- description
- \- Will be asked to undergo 64Cu-LLP2A-PET/CT imaging at up to three separate time points for purposes of calculating human dosimetry. Imaging time points will be dependent upon day of the week injection occurs: * Tuesday or Thursday injection: 0-60 minute multiple quick body scans + 120-180 min post injection body scan * Wednesday or Friday injection: 0-60 minute multiple quick body scans + 180-240 min post injection body scan * ALL PATIENTS: 15-28 hours post injection body scan on Wednesday (for Tuesday injection), Thursday (for Wednesday injection), Friday (for Thursday injection) or Saturday (for Friday injection)
- interventionNames
- Drug: 64Cu-LLP2A
- Device: PET/CT
- type
- EXPERIMENTAL
- label
- Cohort 2B: Quantitative 64Cu-LLP2A
- description
- \- Will be asked to undergo dynamic PET/CT imaging centered over a known target lesion (as determined by other radiological imaging studies) beginning with 64Cu-LLP2A-PET/CT and continuing for a total of 60 minutes. An additional vertex to upper thigh body scan will be obtained between 60- and 180-minutes post injection or at the optimal imaging time point that was derived from cohort 1B.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria Healthy Volunteer: * Adult 18 years of age or older * Able to give informed consent. * Able to comprehend and willing to follow instructions for study procedures as called for by the protocol * Capable of lying still and supine within the PET/CT scanner for up to 75 minutes. * No illicit drug use or other inhaled drug use (including pharmacologic agents and illicit drugs) within the past year per self-reporting mechanisms. * No history of claustrophobia or other condition that has previously or would interfere with completion of protocol specified imaging sessions. * Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post-menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 64Cu-LLP2A) is negative. Inclusion Criteria Hematological Malignancy: * Clinical or pathologically defined MM or lymphoma including both newly diagnosed, relapsed or refractory disease: * Multiple Myeloma defined in accordance with the International Myeloma Working Group criteria * Low-grade lymphoma, including the following subtypes: follicular lymphoma, marginal zone lymphoma, lymphoplasmacytic lymphoma, small lymphocytic lymphoma/chronic lymphocytic leukemia * Adult 18 years of age or older and able to provide informed consent * Capable of lying still and supine within the PET/CT scanner for up to 75 minutes. * No history of claustrophobia or other condition that has previously or would interfere with completion of protocol specified imaging sessions * Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post-menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 64Cu-LLP2A) is negative * Patients participating in imaging or therapeutic trials with investigational agents are eligible to participate
References
Publications (0)
Data not yet available
No reference posted for this study.