Description:
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.
Title
- Brief Title: A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory T or B Cell Malignancies (COBALT-LYM)
- Official Title: A Phase 1, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Anti-CD70 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX130) in Subjects With Relapsed or Refractory T or B Cell Malignancies
Clinical Trial IDs
- ORG STUDY ID:
CRSP-ONC-004
- NCT ID:
NCT04502446
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| CTX130 | | CTX130 |
Purpose
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.
Detailed Description
The study may enroll approximately 45 subjects in total.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| CTX130 | Experimental | Administered by IV infusion following lymphodepleting chemotherapy. | |
Eligibility Criteria
Inclusion Criteria (abbreviated):
1. Age ≥18 years and body weight ≥60 kg.
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.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Part A (dose escalation) |
| Time Frame: | From CTX130 infusion up to 28 days post-infusion |
| Safety Issue: | |
| Description: | Incidence of adverse events |
Secondary Outcome Measures
| Measure: | Progression Free Survival |
| Time Frame: | From date of CTX130 infusion until date of disease progression or death due to any cause, assessed up to 60 months |
| Safety Issue: | |
| Description: | |
| Measure: | Overall Survival |
| Time Frame: | From date of CTX130 until date of death due to any cause, assessed up to 60 months |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | CRISPR Therapeutics AG |
Trial Keywords
Last Updated
July 15, 2021
