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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

Must not have

Known malignancy other than study indication that is progressing or has required treatment within the past three years

Have specific conditions such as Non-secretory or oligosecretory MM, Plasma cell leukemia, Systemic light chain amyloidosis, and others

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

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have no other cancers that have worsened or needed treatment in the last 3 years.

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I have a specific blood or bone marrow condition.

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I am not taking any strong medications that affect liver enzymes.

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I have not received a live vaccine in the last 4 weeks.

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I have tested positive for Hepatitis B.

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I have been diagnosed with HIV.

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I have active inflammation in my lungs.

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I have a condition affecting my brain or spinal cord.

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I have moderate to severe numbness, tingling, or pain in my hands or feet.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through 30 days after the last dose of study treatment

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1: MTD or recommended RP2D for cemsidomide in combination with dexamethasone

Phase 1: Maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) for cemsidomide

Phase 1: Safety and tolerability of cemsidomide

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 cemsidomide single agent

Group II: Phase 2: Arm 3 - cemsidomideExperimental Treatment1 Intervention

Participants with r/r mantle cell lymphoma (MCL) treated with oral CFT7455

Group III: Phase 2: Arm 2 - cemsidomide in combination with dexamethasoneExperimental Treatment2 Interventions

Participants with r/r MM treated with oral cemsidomide in combination with oral dexamethasone

Group IV: Phase 2: Arm 1 - cemsidomideExperimental Treatment1 Intervention

Participants with r/r MM will be treated with oral cemsidomide single agent

Group V: Phase 1: Arm C - cemsidomideExperimental Treatment1 Intervention

Participants with r/r NHL will be treated with escalating doses of oral cemsidomide single agent administered according to different dosing schedules in each cohort

Group VI: Phase 1: Arm B2 - cemsidomide in combination with dexamethasoneExperimental Treatment2 Interventions

Participants with r/r MM will be treated with escalating doses of oral cemsidomide in combination with a fixed dose of oral dexamethasone in each cohort

Group VII: Phase 1: Arm B1 - cemsidomideExperimental Treatment1 Intervention

Participants with r/r MM will be treated with escalating doses of oral cemsidomide as a single agent administered at different dosages and dosing schedules in each cohort, until the determination of maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) or Sponsor discretion.

Group VIII: Phase 1: Arm A - cemsidomideExperimental Treatment1 Intervention

Participants with r/r NHL or r/r MM will be treated with oral cemsidomide as a single agent administered at different dosages and dosing schedules.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone Oral

2020

N/A

~14110

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