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Closed (no longer recruiting)Last updated: 8 November 2023

CRISPER: This phase I/II trial is evaluating a new type of immunotherapy (CTX110) in patients with B-Cell malignancies (Non-Hodgkin Lymphoma) that have got worse or not responded to prior treatmentA Phase 1/2 Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Allogeneic CRISPR-Cas9-Engineered T Cells (CTX110) in Subjects With Relapsed or Refractory B-Cell Malignancies

Clinical summary

Summary

This is a dose escalation and expansion trial. Eligible participants will receive CTX110 (a CD19-directed T-cell immunotherapy) by intravenous infusion, followed by lymphodepleting chemotherapy.

Conditions

This trial is treating patients with Non-Hodgkin Lymphoma.

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I/II

Trial Acronym

CRISPER

More information

Trial Identifiers

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Trial sponsor

CRISPR Therapeutics AG

Scientific Title

A Phase 1/2 Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Allogeneic CRISPR-Cas9-Engineered T Cells (CTX110) in Subjects With Relapsed or Refractory B-Cell Malignancies

Eligibility

Inclusion

  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.

Exclusion

  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.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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