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CAR T-cell Therapy

CTX130 for T-Cell Lymphoma

Phase 1

Waitlist Available

Research Sponsored by CRISPR Therapeutics AG

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years.

Confirmed diagnosis of a T cell malignancy or Diffuse Large B-Cell Lymphoma (DLBCL).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from ctx130 infusion up to 60 months post-infusion]

Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it is safe and effective in people with relapsed or refractory T or B cell malignancies.

Who is the study for?

This trial is for adults over 18 with T cell malignancies or Diffuse Large B-Cell Lymphoma, who are relatively healthy (ECOG 0-1). They must be able to use contraception and have good kidney, liver, heart, and lung function. People with prior organ transplants, other active cancers or infections like HIV/HBV/HCV, pregnant/breastfeeding women, those with immune/autoimmune disorders needing treatment, previous stem cell transplant recipients or anti-CD70 therapy patients can't join.Check my eligibility

What is being tested?

The study is testing CTX130's safety and effectiveness in treating relapsed/refractory T or B cell malignancies. It's a Phase 1 trial where all participants receive the same experimental therapy without comparison to a control group. The trial is open-label meaning both researchers and participants know what treatment is being given.See study design

What are the potential side effects?

While specific side effects of CTX130 aren't listed here, similar therapies often cause immune-related reactions that could affect various organs. Participants may experience infusion reactions along with general symptoms like fatigue and increased susceptibility to infections.

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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I have been diagnosed with a T cell malignancy or DLBCL.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from ctx130 infusion up to 60 months post-infusion]

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from ctx130 infusion up to 60 months post-infusion]

This trial's timeline: 3 weeks for screening, Varies for treatment, and from ctx130 infusion up to 60 months post-infusion] for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part A (dose escalation)

Part B (cohort expansion)

Secondary outcome measures

Overall Survival

Progression Free Survival

Trial Design

1Treatment groups

Experimental Treatment

Group I: CTX130Experimental Treatment1 Intervention

Administered by IV infusion following lymphodepleting chemotherapy.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

CRISPR Therapeutics AGLead Sponsor

8 Previous Clinical Trials

847 Total Patients Enrolled

Matthias Will, MDStudy DirectorCRISPR Therapeutics

3 Previous Clinical Trials

224 Total Patients Enrolled

Anjali Sharma, MDStudy DirectorCRISPR Therapeutics

1 Previous Clinical Trials

107 Total Patients Enrolled

Media Library

CTX130 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04502446 — Phase 1

T-Cell Lymphoma Research Study Groups: CTX130

T-Cell Lymphoma Clinical Trial 2023: CTX130 Highlights & Side Effects. Trial Name: NCT04502446 — Phase 1

CTX130 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04502446 — Phase 1

Frequently Asked Questions

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

How many participants are currently partaking in this clinical experiment?

"This trial necessitates the recruitment of 45 volunteers who adhere to its inclusion criteria. Potential participants can join at any one of two primary research sites - Duarte, California and Houston, Texas."

Answered by AI

Are there any clinical research centers in North America conducting this trial?

"Presently, this trial is operating from 9 distinct sites. These locations include Duarte, Houston and Salt Lake City as well as 6 other places of residence. It would be most beneficial to select the closest location in order to limit any possible travelling inconveniences should you choose to take part."

Answered by AI

Is there still capacity to enroll individuals in this experiment?

"Affirmative. Clinicaltrials.gov provides evidence that this experiment is presently recruiting participants, which it has been doing since July 31st 2020. 45 applicants are desired from 9 separate locations for the trial's duration."

Answered by AI

Has the FDA given its stamp of approval for CTX130?

"As this is an early-stage trial, the safety of CTX130 has been evaluated as a 1 on Power's scale. This rating indicates that there is limited data available to assess its efficacy and safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory T or B Cell Malignancies (COBALT-LYM)

2020. "A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory T or B Cell Malignancies (COBALT-LYM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04502446.