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A Safety and Efficacy Study Evaluating CTX110 in Subjects With Relapsed or Refractory B-Cell Malignancies (CARBON)

Sponsored by CRISPR Therapeutics AG

About this trial

Last updated a year ago

Study ID

CRSP-ONC-001

Status

Active, not recruiting

Type

Interventional

Phase

Phase 1/Phase 2

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 6 years ago

What is this trial about?

This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX110 in subjects with relapsed or refractory B-cell malignancies.

What are the Participation Requirements?

Key Inclusion Criteria:

1. For NHL patients: Age ≥18 years. For B cell ALL patients: age ≥18 years to ≤70 years

2. Refractory or relapsed non-Hodgkin lymphoma, as evidenced by 2 or more lines of
prior therapy, or histologically confirmed B cell ALL, refractory or relapsed.

3. Eastern Cooperative Oncology Group performance status 0 or 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 CTX110 infusion.

Key Exclusion Criteria:

1. For NHL patients: prior allogeneic HSCT. For B cell ALL patients: prior allogeneic
HSCT within 6 months, and/or any evidence of GvHD.

2. History of central nervous system (CNS) involvement by malignancy

3. History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia,
cerebellar disease, or any autoimmune disease with CNS involvement.

4. Presence of bacterial, viral, or fungal infection that is uncontrolled.

5. Positive for HIV, or active hepatitis B virus or hepatitis C virus infection.

6. Previous or concurrent malignancy, except basal cell or squamous cell skin
carcinoma, adequately resected and in situ carcinoma of cervix, or a previous
malignancy that was completely resected and has been in remission for ≥5 years.

7. For NHL patients: Use of systemic anti-tumor therapy or investigational agent within
14 days or 5 half-lives, whichever is longer, of CTX110 infusion. For B cell ALL
patients: Use of systemic antitumor therapy within 7 days of CTX110 infusion.

8. Primary immunodeficiency disorder or active autoimmune disease requiring steroids
and/or other immunosuppressive therapy.

9. Women who are pregnant or breastfeeding.

Locations

Location

Status