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RecruitingLast updated: 8 November 2023

Ardent: This study is evaluating how safe, tolerable and effective a new immunotherapy (called SC291) is when given after chemotherapy in people with relapsed and/or refractory B-cell cancersA Phase 1 Study Evaluating SC291, a Hypoimmune, Allogeneic CD19-directed CAR T Cell Therapy, in Relapsed and/or Refractory B-cell Malignancies

Clinical summary

Summary

Eligible participants will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide, followed by investigational treatment with SC291.

Conditions

This trial is treating patients with B-cell malignancies

Cancer

Blood Cancers Haematological

Age

People18 - 75

Phase

I

Trial Acronym

Ardent

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Sana Biotechnology

Scientific Title

A Phase 1 Study Evaluating SC291, a Hypoimmune, Allogeneic CD19-directed CAR T Cell Therapy, in Relapsed and/or Refractory B-cell Malignancies

Eligibility

Inclusion

  • Male or female subjects aged 18-75 years at the time of signing informed consent.
  • Diagnosis of NHL (WHO 2016 criteria) or CLL (iwCLL criteria), including:
  • Large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise - - specified (including DLBCL arising from indolent lymphoma), primary mediastinal large -- - B-cell lymphoma, high grade B-cell lymphoma, follicular lymphoma grade 3B
  • Follicular lymphoma (dose escalation only except for follicular lymphoma grade 3B)
  • Marginal zone lymphoma (dose escalation only)
  • Mantle cell lymphoma (dose escalation only)
  • CLL or SLL
  • Relapsed/refractory disease after at least 2 prior systemic regimens per standard of care or after autologous stem cell transplant
  • ECOG performance status of 0 or 1.
  • At least one measurable lesion per Lugano Classification (NHL); CLL subjects must meet iwCLL treatment criteria
  • Life expectancy ≥12 weeks

Exclusion

  • Prior anti-CD19 therapy including CD19-directed CAR T treatment or other CD19-directed antibody or cell therapy (e.g., NK cell). (Part 2 dose expansion only - prior approved CD19-directed CAR T therapy required)
  • History of primary central nervous system (CNS) lymphoma or presence of CNS metastases
  • Systemic anticancer therapy (including platinum-based chemotherapies and I/O therapies) or radiotherapy within 14 days of SC291 (28 days for biologics)
  • Autologous HSCT within 6 weeks of treatment with SC291 (or allogeneic HSCT at any time).
  • Active autoimmune disease or any other diseases requiring immunosuppressive therapy or corticosteroid therapy (defined as >20 mg/day prednisone or equivalent).
  • History or presence of cardiac or CNS disorders as defined in the protocol

Inclusion

  • You have had a certain type of treatment or surgical procedure.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • 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.

Ask your doctor if this trial could be right for you.

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