CTX130 for T-Cell Lymphoma

Recruiting at 9 trial locations

Overseen By Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: CRISPR Therapeutics AG

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: Prior SCT, CNS conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

49 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a single-arm, open-label, multicenter, Phase 1 study evaluating the safety and efficacy of CTX130 in subjects with relapsed or refractory T or B cell malignancies.

Research Team

Alissa Keegan, PhD

Principal Investigator

CRISPR Therapeutics

Eligibility Criteria

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.

Inclusion Criteria

I agree to use birth control from enrollment through 12 months after treatment.

My kidney, liver, heart, and lung functions are all good.

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

Exclusion Criteria

I have an immune system disorder or autoimmune disease treated with steroids or other immune-suppressing drugs.

Pregnant or breastfeeding females.

I do not have active HIV, hepatitis B, or hepatitis C.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lymphodepleting Chemotherapy

Participants receive lymphodepleting chemotherapy prior to CTX130 infusion

1-2 weeks

Treatment

CTX130 is administered by IV infusion

1 day

Initial Follow-up

Participants are monitored for adverse events post-infusion

4 weeks

Long-term Follow-up

Participants are monitored for objective response rate

60 months

Treatment Details

Interventions

• CTX130

Trial Overview 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.

Participant Groups

Group I: CTX130 Experimental Treatment 1 Intervention

Administered by IV infusion following lymphodepleting chemotherapy.

Who Is Running the Clinical Trial?

CRISPR Therapeutics AG

Lead Sponsor

Trials

9

Recruited

640+