A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory T or B Cell Malignancies (COBALT-LYM)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04502446 |
Recruitment Status :
Recruiting
First Posted : August 6, 2020
Last Update Posted : May 17, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
T Cell Lymphoma | Biological: CTX130 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 45 participants |
Allocation: | N/A |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | July 31, 2020 |
Estimated Primary Completion Date : | March 2027 |
Estimated Study Completion Date : | May 2027 |

Arm | Intervention/treatment |
---|---|
Experimental: CTX130
Administered by IV infusion following lymphodepleting chemotherapy.
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Biological: CTX130
CTX130 CD70-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components. |
- Part A (dose escalation) [ Time Frame: From CTX130 infusion up to 28 days post-infusion ]Incidence of adverse events
- Part B (cohort expansion) [ Time Frame: From CTX130 infusion up to 60 months post-infusion] ]Objective response rate
- 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 ]
- Overall Survival [ Time Frame: From date of CTX130 until date of death due to any cause, assessed up to 60 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria (abbreviated):
- Age ≥18 years.
- Confirmed diagnosis of a T cell malignancy or Diffuse Large B-Cell Lymphoma (DLBCL).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Adequate renal, liver, cardiac, and pulmonary organ function.
- 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):
- Prior allogeneic stem cell transplant (SCT).
- Prior treatment with any anti-CD70 targeting agents.
- History of certain central nervous system (CNS), cardiac or pulmonary conditions.
- Active HIV, hepatitis B virus or hepatitis C virus infection.
- 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.
- Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
- Prior solid organ transplantation.
- Pregnant or breastfeeding females.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04502446
Contact: Clinical Trials | +1 (877) 214-4634 | MedicalAffairs@crisprtx.com |
United States, California | |
Research Site 2 | Recruiting |
Duarte, California, United States, 91010 | |
Research Site 5 | Recruiting |
Stanford, California, United States, 94305 | |
United States, Connecticut | |
Research Site 10 | Recruiting |
New Haven, Connecticut, United States, 06520 | |
United States, Florida | |
Research Site 4 | Recruiting |
Miami, Florida, United States, 33124 | |
United States, New York | |
Research Site 8 | Recruiting |
Bronx, New York, United States, 10467 | |
Research Site 9 | Recruiting |
New York, New York, United States, 10065 | |
United States, Texas | |
Research Site 1 | Recruiting |
Houston, Texas, United States, 77030 | |
United States, Utah | |
Research Site 6 | Recruiting |
Salt Lake City, Utah, United States, 84112 | |
Australia, New South Wales | |
Research Site 3 | Recruiting |
Sydney, New South Wales, Australia, 2050 | |
Canada, Ontario | |
Research Site 7 | Recruiting |
Toronto, Ontario, Canada, M5G 2C1 |
Study Director: | Anjali Sharma, MD | CRISPR Therapeutics |
Responsible Party: | CRISPR Therapeutics AG |
ClinicalTrials.gov Identifier: | NCT04502446 |
Other Study ID Numbers: |
CRSP-ONC-004 |
First Posted: | August 6, 2020 Key Record Dates |
Last Update Posted: | May 17, 2022 |
Last Verified: | July 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
CAR T Allogeneic Lymphoma |
Lymphoma, T-Cell Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |