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Engineered donor cells take on tough lymphomas and leukemias

NCT ID NCT05878184

Disease control Sponsor: Sana Biotechnology Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study tests SC291, a CAR T-cell therapy made from donor cells, in 16 adults with relapsed or refractory B-cell non-Hodgkin lymphoma or chronic lymphocytic leukemia. The goal is to check safety and see if the treatment can shrink tumors. Because it uses donor cells, it could be available faster than personalized therapies, but it also carries risks of immune reactions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SC291 (a type of CAR T-cell therapy made from donor cells)
What this could lead to
If it works, this could provide a new treatment option for people with hard-to-treat blood cancers who have run out of standard therapies.
What could go wrong
This is a very early (Phase 1) trial with only 16 participants, so safety and effectiveness are not yet proven. There are risks of serious side effects like cytokine release syndrome or immune reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

16 people

The number who actually took part.

Started

May 2023

Expected to finish

Nov 2038

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female subjects aged 18-80 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 Criteria: * 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

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia diffuse large B-cell lymphoma follicular lymphoma high grade B-cell lymphoma large B-cell lymphoma Lymphoma, B-Cell, Marginal Zone mantle cell lymphoma marginal zone lymphoma non-Hodgkin lymphoma primary mediastinal large B-cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic lymphocytic leukemia Non-Hodgkin lymphoma

Contacts and locations

Locations

  • City of Hope

    Duarte, California, 91010, United States

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Linear Clinical Research Ltd

    Nedlands, Western Australia, 6009, Australia

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Northside Hospital

    Atlanta, Georgia, 30342, United States

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • Stanford Cancer Institute

    Palo Alto, California, 94304, United States

  • University of Kansas Medical Center

    Fairway, Kansas, 66205, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

More trials for these conditions

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