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A Study of TTI-622 in Combination With Daratumumab Hyaluronidase-fihj in People With Multiple Myeloma

NCT05139225 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2025-11-04

No results posted yet for this study

Summary

This study will test the safety of TTI-622 in combination with daratumumab hyaluronidase-fihj in people with relapsed/refractory multiple myeloma. The researchers look for the highest dose TTI-622 that causes few or mild side effects in participants when given in combination with daratumumab hyaluronidase-fihj. Once the researchers find the highest safe dose of each study drug, they will further test the combination TTI-622 + daratumumab hyaluronidase-fihj) in new participants to find out if the combinations are effective in treating relapsed/refractory multiple myeloma. Researchers think that combining TTI-621 or TTI-622 with daratumumab hyaluronidase-fihj, a standard treatment for multiple myeloma, may be an effective treatment approach.

Conditions

Interventions

DRUG

TTI-622

(-2) 0.4 mg/kg (-1) 0.8 mg/kg (1 ) 1.2 mg/kg (2) 2 mg/kg (3) 4 mg/kg (4) 8 mg/kg (5) 12 mg/kg The appropriate dose of TTI-622 will be administered IV over 60 minutes, however, can be extended up to 4 hours to mitigate Infusion-related reactions.

DRUG

Daratumumab Hyaluronidase-fihj

Daratumumab hyaluronidase-fihj SC 1800 mg days 1, 8, 15, and 22.

Sponsors & Collaborators

Principal Investigators

  • Alexander Lesokhin, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-28
Primary Completion
2026-10-31
Completion
2026-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05139225 on ClinicalTrials.gov