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Anti-tumor agent

CFT7455 for Lymphoma

Phase 1 & 2
Recruiting
Research Sponsored by C4 Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years at the time of signed consent
Have histologically or cytologically-confirmed NHL or MM that is r/r disease and must not be candidates for regimens known to provide clinical benefit to be eligible for the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through 6 months after the last dose of study treatment, or until disease progression, whichever occurs first
Awards & highlights

Study Summary

This trial is testing an investigational drug to treat NHL or MM that has relapsed or is refractory to other treatments. The drug will be given orally according to different dosing schedules.

Who is the study for?
Adults with relapsed/refractory Non-Hodgkin's Lymphoma or Multiple Myeloma who've had specific prior treatments can join. They must have measurable disease, not be pregnant or planning to conceive, and agree to contraception. Exclusions include active pneumonitis, CNS disease, recent radiotherapy, HIV/Hepatitis B/C infection, certain other cancers within 3 years.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of CFT7455 alone or combined with oral dexamethasone in different dosing schedules for those with certain types of blood cancer that haven't responded well to previous treatments.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system due to CFT7455 or complications from combining it with dexamethasone. Specific side effects are not listed but generally could involve changes in blood counts, liver function issues, nausea, fatigue among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My lymphoma or myeloma is resistant to treatment and I can't use known effective treatments.
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I am not pregnant, not breastfeeding, and meet the specific conditions.
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I have had at least 3 treatments for myeloma, including 2 cycles of specific drugs.
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I have been diagnosed with multiple myeloma and it can be measured.
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I am a male and will use contraception during and after the study as required.
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I have received treatment specific to my type of non-Hodgkin lymphoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through 30 days after the last dose of study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 30 days after the last dose of study treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dexamethasone
Phase 1: Maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) for CFT7455
Phase 1: Safety and tolerability of CFT7455
+3 more

Trial Design

8Treatment groups
Experimental Treatment
Group I: Phase 2: Arm 4 - CFT7455Experimental Treatment1 Intervention
Participants with r/r peripheral T-cell lymphoma (PTCL) treated with oral CFT7455
Group II: Phase 2: Arm 3 - CFT7455Experimental Treatment1 Intervention
Participants with r/r mantle cell lymphoma (MCL) treated with oral CFT7455
Group III: Phase 2: Arm 2 - CFT7455 in combination with dexamethasoneExperimental Treatment2 Interventions
Participants with r/r MM treated with oral CFT7455 in combination with oral dexamethasone
Group IV: Phase 2: Arm 1 - CFT7455Experimental Treatment1 Intervention
Participants with r/r MM will be treated with oral CFT7455
Group V: Phase 1: Arm C - CFT7455Experimental Treatment1 Intervention
Participants with r/r NHL will be treated with escalating doses of single agent CFT7455 administered according to different dosing schedules in each cohort until determination of MTD/RP2D
Group VI: Phase 1: Arm B2 - CFT7455 in combination with dexamethasoneExperimental Treatment2 Interventions
Participants with r/r MM will be treated with oral CFT7455 in combination with a fixed dose of oral dexamethasone in each cohort
Group VII: Phase 1: Arm B1 - CFT7455Experimental Treatment1 Intervention
Participants with r/r MM will be treated with escalating doses of single agent CFT7455 administered according to different dosing schedules until the determination of maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D)
Group VIII: Phase 1: Arm A - CFT7455Experimental Treatment1 Intervention
Participants with r/r NHL or r/r MM will be treated with oral CFT7455 as a single agent administered according to different dosing schedules
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone Oral
2020
N/A
~14110

Find a Location

Who is running the clinical trial?

C4 Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
256 Total Patients Enrolled
Michelle Mahler, MDStudy DirectorC4 Therapeutics, Inc.
Adam Crystal, MDStudy DirectorC4 Therapeutics, Inc.

Media Library

CFT7455 (Anti-tumor agent) Clinical Trial Eligibility Overview. Trial Name: NCT04756726 — Phase 1 & 2
Multiple Myeloma Research Study Groups: Phase 2: Arm 4 - CFT7455, Phase 2: Arm 1 - CFT7455, Phase 2: Arm 2 - CFT7455 in combination with dexamethasone, Phase 1: Arm A - CFT7455, Phase 1: Arm B1 - CFT7455, Phase 1: Arm B2 - CFT7455 in combination with dexamethasone, Phase 1: Arm C - CFT7455, Phase 2: Arm 3 - CFT7455
Multiple Myeloma Clinical Trial 2023: CFT7455 Highlights & Side Effects. Trial Name: NCT04756726 — Phase 1 & 2
CFT7455 (Anti-tumor agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04756726 — Phase 1 & 2
~46 spots leftby Sep 2025
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