Health TrialsbyHealthPanel

A Safety and Efficacy Study Evaluating CTX112 in Subjects With Relapsed or Refractory B-Cell Malignancies

ConditionsB-cell LymphomaNon-Hodgkin LymphomaB-cell MalignancyChronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)Follicular LymphomaMantle Cell LymphomaMarginal Zone LymphomaLarge B-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCRISPR Therapeutics AG

About this trial

This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX112™ in subjects with relapsed or refractory B-cell malignancies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years.

Refractory or relapsed B cell malignancy.

Eastern Cooperative Oncology Group performance status 0 or 1.

Adequate renal, liver, cardiac and pulmonary organ function.

Disqualifiers

Prior allogeneic hematopoietic stem cell transplant (HSCT).

Active or history of central nervous system (CNS) involvement by malignancy.

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

Presence of bacterial, viral, or fungal infection that is uncontrolled or requires IV anti-infectives.

Trial design

Design model

Sequential

Treatments tested in this trial

  • CTX112

    Biological/Vaccine

    CTX112 (CD19-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components)

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: CTX112Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Phase 1 (Dose Escalation): Incidence of adverse events, defined as dose-limiting toxicities

Time frame
From CTX112 infusion up to 28 days post-infusion
2

Phase 2 (Cohort Expansion): Objective response rate

Time frame
From CTX112 infusion up to 60 months post-infusion

Secondary outcomes

1

Duration of Response

Duration of Response (DOR) will only be reported for subjects who have had CR/PR events

Time frame
From date of first objective response of complete response (CR)/partial response (PR) until date of disease progression or death due to any cause, assessed up to 60 months
2

Duration of Clinical Benefit (DOCB)

Time frame
From date of first objective response of CR/PR until the relapse or death that followed the last response, assessed up to 60 months
3

Progression Free Survival

Time frame
From date of CTX112 infusion until date of disease progression or death due to any cause, assessed up to 60 months
4

Overall Survival

Time frame
From date of CTX112 infusion until date of death due to any cause, assessed up to 60 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CRISPR Therapeutics AG

Lead sponsor

Source ClinicalTrials.gov
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