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

CRISPR Therapeutics

Status and phase: Terminated; Phase 1

Conditions: T Cell Lymphoma

Treatments: Biological: CTX130

Study type: Interventional

Funder types: Industry

Identifiers

NCT04502446

CRSP-ONC-004

Details and patient eligibility

About

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.

Full description

The study may enroll approximately 45 subjects in total.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (abbreviated):

1. Age ≥18 years.
2. Confirmed diagnosis of a T cell malignancy or Diffuse Large B-Cell Lymphoma (DLBCL).
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Adequate renal, liver, cardiac, and pulmonary organ function.
5. Female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after CTX130 infusion.

Exclusion Criteria (abbreviated):

1. Prior allogeneic stem cell transplant (SCT).
2. Prior treatment with any anti-CD70 targeting agents.
3. History of certain central nervous system (CNS), cardiac or pulmonary conditions.
4. Active HIV, hepatitis B virus or hepatitis C virus infection.
5. Previous or concurrent malignancy, except treated with curative approach not requiring systemic therapy and in remission for >12 months, or any other localized malignancy with low risk of developing into metastatic disease.
6. Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
7. Prior solid organ transplantation.
8. Pregnant or breastfeeding females.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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49 participants in 1 patient group

CTX130

Experimental group

Description:

Administered by IV infusion following lymphodepleting chemotherapy.

Treatment:

Biological: CTX130