64Cu-LLP2A for Imaging Hematologic Malignancies

The Washington University

Status and phase: Enrolling; Early Phase 1

Conditions: Multiple Myeloma; Marginal Zone Lymphoma; Small Lymphocytic Lymphoma; Follicular Lymphoma; Chronic Lymphocytic Leukemia; Lymphoplasmacytic Lymphoma; Low-Grade Lymphoma

Treatments: Device: PET/CT; Drug: 64Cu-LLP2A

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06636175

202505198

R42CA257797 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Pilot/Cohort 1B: Dosimetry 64Cu-LLP2A

Experimental group

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)

Treatment:

Drug: 64Cu-LLP2A

Device: PET/CT

Cohort 2B: Quantitative 64Cu-LLP2A

Experimental group

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.

Treatment:

Drug: 64Cu-LLP2A

Device: PET/CT