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Second-Chance stem cell therapy for blood cancer patients

NCT ID NCT07346105

Disease control Sponsor: Orca Biosystems, Inc. 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This program gives patients with certain blood cancers access to Orca-T, a donor stem cell therapy, when the commercial version cannot be used. It is for people who have no other treatment options. The program monitors safety but does not test if the therapy works.

What this could mean

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

Active substance
Orca-T (a donor stem cell therapy for blood cancers)
What this could lead to
If successful, this program could offer a treatment option for patients with blood cancers who have no other approved therapy available.
What could go wrong
This is an expanded access program, not a formal trial, so results are limited. The product is out of specification, which may increase risks like graft failure or severe side effects.

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.

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

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: Recipients in this EAP must meet all of the following criteria: 1. Commercial Orca-T was prescribed to the patient by their treating physician. 2. The final manufactured Orca-T does not meet the commercial release specifications or is delivered past expiry. 3. The final manufactured Orca-T is acceptable per joint assessment by Orca Bio and the treating physician, taking into account Orca Bio's release criteria. 4. Remanufacturing (ie, repeat leukapheresis and manufacturing) is not clinically appropriate per the treating physician's assessment. 5. Recipient must be deemed medically fit and stable to receive Orca-T infusions per the treating physician's evaluation. Exclusion Criteria: Recipients with any medical condition identified by the treating physician that may impact the safety or outcomes of the recipient in relation to treatment with Orca-T will not be eligible.

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Conditions

The condition(s) this trial relates to.

acute biphenotypic leukemia acute lymphoblastic leukemia acute myeloid leukemia hematopoietic and lymphoid system neoplasm mixed phenotype acute leukemia myelodysplastic syndrome Myelodysplastic Syndromes Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

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

Acute lymphoid leukemia Acute myeloid leukemia Hematologic malignancies Mixed phenotype acute leukemia Myelodysplastic syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

More trials for these conditions

Other studies related to the condition(s) this trial covers.