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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 3 months after the last dose of study treatment

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through 3 months after the last dose of study treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through 3 months after the last dose of study treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 3 months 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

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

C4 Therapeutics, Inc.Lead Sponsor

2 Previous Clinical Trials

152 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment phase of this trial still open to prospective participants?

"As indicated by information on clinicaltrials.gov, the trial is still open for enrolment and was originally posted on April 27th 2021 with the latest update occurring this past April 13th 2022."

Answered by AI

How many guinea pigs are involved in the experiment?

"This trial necessitates 158 qualified patients to be enrolled, and these individuals can join in at Memorial Sloan Kettering Cancer Center (New york) or University of California-San Francisco (California)."

Answered by AI

Have there been additional investigations involving CFT7455?

"The initial research with CFT7455 took place in 2002, conducted by Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. Since then, 1098 trials have been finished and 552 are still being carried out across the United States of America; a majority of these experiments taking place in New york City."

Answered by AI

What condition is CFT7455 typically prescribed for?

"CFT7455 has proven to be a successful intervention for ophthalmia, sympathetic and can also assist with branch retinal vein occlusion, macular edema among other eye-related issues."

Answered by AI

Is this research experiment being conducted in multiple locations across North America?

"14 facilities have been selected to recruit patients for this clinical trial. Memorial Sloan Kettering Cancer Center (New york), University of California-San Francisco, and Colorado Blood Cancer Institute are amongst the chosen sites, with 11 other medical centres joining them in their mission."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Assess the Safety and Tolerability of CFT7455 in Relapsed/Refractory Non-Hodgkin's Lymphoma or Multiple Myeloma

2021. "Study to Assess the Safety and Tolerability of CFT7455 in Relapsed/Refractory Non-Hodgkin's Lymphoma or Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04756726.

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