By InvitationNot Applicable

Long-Term Follow-up Study

United States150 participantsStarted 2022-03-16

Plain-language summary

This is an observational, non-interventional, LTFS of investigational Caribou therapies in patients who have participated in a parent study: a prior Caribou-sponsored clinical study, special access program, or an IIT. The objective is to evaluate the long-term safety, through 15 years post infusion, in patients who received IPs in a Caribou-sponsored clinical study, special access program or IIT.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Written informed consent (by patient or legal representative) obtained prior to study-specific activities/enrollment * Completed a Caribou-sponsored study or was administered Caribou IP under a special access program or as part of an IIT * Use of an effective method of birth control by women of childbearing potential and their partners and men with partners of childbearing potential (partners must also use an effective birth control method) through 12 months post IP infusion. Exclusion Criteria: * None

What they're measuring

Incidence of targeted NSAEs

Timeframe: 15 Years

Frequency of targeted NSAEs

Timeframe: 15 Years

Duration of targeted NSAEs

Timeframe: 15 Years

Outcome of targeted NSAEs

Timeframe: 15 Years

Incidence of AESIs

Timeframe: 15 Years

Frequency of AESIs

Timeframe: 15 Years

Duration of AESIs

Timeframe: 15 Years

Outcome of AESIs

Timeframe: 15 Years

Incidence of targeted SAEs

Timeframe: 15 Years

Trial details

NCT IDNCT05332054

SponsorCaribou Biosciences, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2041-12

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