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

Conditions

• Multiple Myeloma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• TTI-622 — DRUG
  (-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.
• Daratumumab Hyaluronidase-fihj — DRUG
  Daratumumab hyaluronidase-fihj SC 1800 mg days 1, 8, 15, and 22.

Study Details

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.

Key Dates

Start date

Oct 28, 2021

Status verified

Nov 2025

Primary completion

Oct 31, 2026

Completion

Oct 31, 2026

Study Design

Enrollment

7 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: TTI-622 dosing will occur over 8 weeks + Daratumumab Hyaluronidase-fihj
  TTI-622 will be administered weekly at the assigned dose levels per the ramp-up schedule. Daratumumab hyaluronidase-fihj 1800 mg will administered on a standard schedule consisting of weekly administration for 8 weeks, every other week administration for 16 weeks, followed by every 4-week administration thereafter.
• Experimental: TTI-622 dosing will occur over 4 weeks + Daratumumab Hyaluronidase-fihj
  TTI-622 will be administered weekly at the assigned dose levels per the ramp-up schedule. Daratumumab hyaluronidase-fihj 1800 mg will administered on a standard schedule consisting of weekly administration for 8 weeks, every other week administration for 16 weeks, followed by every 4-week administration thereafter.

Primary Outcome Measure

Incidence of dose-limiting toxicities [ Time Frame: 28-day observation period following C1D1 of therapy ]

Locations (7)

Find similar trials in Basking Ridge, NJ

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