A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory T or B Cell Malignancies

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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

Brief Summary

      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.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Part A (dose escalation)

Secondary Outcome

 Progression Free Survival

Condition

T Cell Lymphoma

Intervention

CTX130

Study Arms / Comparison Groups

 CTX130
Description:  Administered by IV infusion following lymphodepleting chemotherapy.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

45

Start Date

July 31, 2020

Completion Date

May 2027

Primary Completion Date

March 2027

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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Matthias Will, MD, +1 (877) 214-4634, [email protected]

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT04502446

Organization ID

CRSP-ONC-004


Responsible Party

Sponsor

Study Sponsor

CRISPR Therapeutics AG


Study Sponsor

Matthias Will, MD, Study Director, CRISPR Therapeutics


Verification Date

July 2021