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

  • STATUS
    Recruiting
  • End date
    May 11, 2027
  • participants needed
    45
  • sponsor
    CRISPR Therapeutics AG
Updated on 11 December 2020
cancer
diffuse large b-cell lymphoma
b-cell lymphoma
large b-cell lymphoma

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.

Description

The study may enroll approximately 45 subjects in total.

Details
Treatment CTX130
Clinical Study IdentifierNCT04502446
SponsorCRISPR Therapeutics AG
Last Modified on11 December 2020

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: T-Cell Lymphoma or Non-Hodgkin's Lymphoma or Lymphoma?
Do you have any of these conditions: t cell lymphoma or Lymphoma or Non-Hodgkin's Lymphoma or T-Cell Lymphoma?
Do you have any of these conditions: Lymphoma or t cell lymphoma or Non-Hodgkin's Lymphoma or T-Cell Lymphoma?
Do you have any of these conditions: Lymphoma or T-Cell Lymphoma or Non-Hodgkin's Lymphoma or t cell lymphoma?
Do you have any of these conditions: t cell lymphoma or Non-Hodgkin's Lymphoma or Lymphoma or T-Cell Lymphoma?
Age 18 years and body weight 60 kg
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

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
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