JNJ-79635322 for Multiple Myeloma and AL Amyloidosis

Recruiting in Palo Alto (17 mi)

+36 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Janssen Research & Development, LLC

Must be taking: Proteasome inhibitors, IMiD agents, Anti-CD38

Must not be taking: Corticosteroids, Gene-modified therapy

Disqualifiers: CNS involvement, Plasma cell leukemia, others

No Placebo Group

Trial Summary

What is the purpose of this trial?The primary purpose of this study is to identify the recommended phase 2 dose (RP2D\[s\]) and schedule(s) to be safe for JNJ-79635322 in Part 1 (dose escalation), and to characterize the safety and tolerability of JNJ-79635322 at the RP2D(s) selected and in disease subgroups in Part 2 (dose expansion).

Will I have to stop taking my current medications?

The trial requires that you stop certain medications before starting the study treatment. Specifically, you must not have taken proteasome inhibitors or radiotherapy within 14 days, immunomodulatory drugs within 7 days, gene-modified adoptive cell therapy within 90 days, or CD3-redirecting therapy within 21 days before the first dose of the study treatment.

Eligibility Criteria

This trial is for adults with relapsed or refractory multiple myeloma or AL amyloidosis who've had several prior treatments, including a proteasome inhibitor, IMiD agent, and anti-CD38 therapy. They must have measurable disease indicators like specific protein levels in blood/urine or certain types of lesions. Participants need to be fairly active and healthy otherwise (ECOG status 0 or 1) and not suitable for other proven therapies.

Inclusion Criteria

My condition allows me to carry out all my usual activities without extra help.

I was diagnosed with AL amyloidosis based on tissue analysis.

My heart pumps well, with an ejection fraction of 45% or higher.

+6 more

Exclusion Criteria

I've taken more than 140 mg of steroids in the last 2 weeks for AL amyloidosis.

My side effects from previous cancer treatments, except for hair loss, scarring from radiation, or nerve damage up to a moderate level, have mostly gone away.

I need extra oxygen due to lung issues from my AL amyloidosis treatment.

+17 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants will receive JNJ-79635322 with dose escalation to identify the recommended phase 2 dose (RP2D)

Up to 2 years 5 months

Dose Expansion

Participants will receive JNJ-79635322 at the RP2D regimen(s) determined in Part 1

Up to 2 years 5 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Participant Groups

The study tests JNJ-79635322's safety at different doses in people with multiple myeloma or AL amyloidosis who haven't responded well to standard treatments. It has two parts: finding the safest dose (Part 1) and then seeing how well it works at that dose across different patient groups (Part 2).

2Treatment groups

Experimental Treatment

Group I: Part 2: Dose ExpansionExperimental Treatment1 Intervention

Participants will receive JNJ-79635322 at the RP2D regimen(s) determined in Part 1.

Group II: Part 1: Dose EscalationExperimental Treatment1 Intervention

Participants will receive JNJ-79635322. The dose will be escalated sequentially until the recommended phase 2 dose (RP2D) regimen(s) have been identified.